Biomedical Engineering Career Careers in the United States

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Biomedical Technician / Supervisor

Job Summary : The Biomed Supervisor is chiefly responsible for the orderly operation of the site and a resource for all technicians. He / She will function at the BMET II or higher-level and will be capable of troubleshooting, repairing and performing preventative maintenance on a wide variety of medical devices including Beds, Mattresses, Ventilators, Wound Pumps, etc? Primary Responsibilities: Will function as a technician as well as a supervisor Will identify training needs for biomedical personnel. Will assure the service area is clean and orderly, providing a safe environment for service personnel. Will assure accurate database entry and reports. Expected to meet production goals set for department to keep rental equipment patient ready. Be able to document and maintain appropriate paperwork for site including employee write ups and routing forms. Manage and perform on-call responsibilities. Organize after-hours on-call rotation for self and staff. Expected to perform all duties under biomedical technician?s responsibilities, including repair, pm, cleaning and delivery driver responsibilities. Responsible for Inventory control and repair part ordering. Will be expected to work Overtime with short notice. Responsible for sale order processing and fulfillment. Responsible for all Distribution Dispatching when the Operations Manager is not available. Expected to provide technical support and troubleshooting for customers as needed. Must assist the ongoing training of service, distribution, sales and customer service personnel. Quality Management System: Responsible for maintaining the effectiveness of the QMS as appointed management representative for branch biomedical employees. Ensures that all QMS and safety procedures are followed. Ensures all required records are completed in an accurate and timely manner and available for audit purposes....

Biomedical Technician Lead

Biomedical Technician Contract/Contract to Hire/Direct Hire Los Angeles, CA *Subject to background and drug screen Pay range: Hourly $25 - $35/h r The Biomedical Technology Specialist III provides high level of expertise in the maintenance and repair complex biomedical systems and devices located within the company. Provide technical leadership and guidance to other Biomedical technicians on project implementations, networking and physiological patient data integration and act as a liaison to IS/PMO for biomedical project matters. Maintains accurate documentation to meet JCAHO and DHS requirements as they pertain to Medical Equipment Management Plan. Under limited direction, responsible for providing physiological monitoring data backup, recovery and security procedures. Has responsibility for the physical management of the Biomedical Engineering data, including regulatory documentation and report production, for various committees, agencies and management presentations. Titles & Number of Employees Supervised: Functional supervision of several Biomedical Technichians II, Biomedical Technichians I and Biomedical Assistant. A great degree of individual responsibility on the part of the technician is required. Approximately only one third of the workload is performed in the workshop, while two thirds is performed in patient care areas. Equipment/Machines Used: Defibrillator analyzer, electro surgical analyzer, electrical safety analyzer, Patient simulator, Oscilloscope, digital/analog multi meter, frequency counter, power supplies, function generator, various hand tools, ultrasound output analyzer, TENS output analyzer, gas flow analyzer, anesthesia gas analyzer, laser power meter, Anesthesia machine, cell savers, ventilator, blood pumps and other electronic diagnostic equipment. To provide the highest quality technical service and to reduce the downtime of essential surgical systems, while completing all scheduled work as required. Interface with medical and nursing personnel, and keeping a professional approach at all times....

Biomedical Technician

Biomedical Technician FT Days: 7:30 am to 4 pm The Biomedical Technician is responsible for ensuring the maintenance of all Biomedical equipment throughout the facility as well as implementing processes for the effective and efficient delivery of services for all aspects of medical equipment at the facility. Biomedical Technician...

Manager Biomedical Engineering

Under limited supervision, organizes, directs and coordinates the work of Biomedical Engineering; helps manage the Clinical Equipment Capital Program and works with Clinical Departments in planning their future equipment requirements. Establishes and implements equipment monitoring, maintenance, and testing procedures Determines staffing requirements and supervise and mentors the work of all biomedical engineering staff to ensure effective and efficient departmental functions. Designs and develops quality assurance measures which monitor the consistency and quality of services. Manages The Joint Commission required Environment of Care Medical Equipment Management Plan and policy and procedures to comply with the Joint Commission for standards of medical equipment management to ensure patient and employee safety. Determines in consultation with the Clinical Engineering Director and end users the appropriate approach to equipment maintenance and services. Establishes service requirements, service standards, and service vehicles. Manages the Clinical Equipment Operating and Capital budget in collaboration with the Director of Clinical Engineering, the VP of Facilities, and Finance. Develops, implements and assures adherence to Biomedical Engineering practices and general departmental policies and procedures to improve the operational efficiency of the engineering and technical activities of Clinical Engineering. In absence of Director being available, the Manager, Biomedical Engineering will function in place of the Director with authority as delegated in advance by the Director....

Director, Biomedical Engineering

Category: Management/Executive Facility: Sidney & Lois Eskenazi Hospital Department: Biomedical Engineering Shift: Days Hours: 7:00 - 3:30 JOB SUMMARY: Eskenazi Health is seeking an innovative leader to fill its Director of Biomedical Engineering position! The successful candidate will coordinate activities, give direction to personnel within the department and serve as a consultant on medical equipment matters. The Director, Biomedical Engineering will be responsible for the following job functions: Responsible for the applications and adherence of personnel to hospital and departmental policies. Conducts/reviews personnel evaluations; ultimate responsibility for hire, discharge and discipline of personnel. Delegates work projects to department personnel for two distinct work areas (medical equipment repair and radiation equipment repair). Supervises new project and equipment evaluations; may include writing specifications designed to make recommendations regarding both new and replacement equipment. Evaluates potential equipment purchases to determine utilization and value; may include organization cost of feasibility studies with proper documentation to facilitate recommendations. Provides consultative service for researchers upon request. Assists in collection /verification of research data. Makes recommendations to management; explains and instructs medical staff with regard to selection and use of equipment. Serves as liaison between medical staff with regard to selection and use of equipment. Responsible for overall in-service education programs for medical staff relative to medical equipment. Develops annual departmental budget....

Intern - Biomedical Engineering

This position supports the Artificial Heart Program at the University of Maryland Medical Center (UMMC). The Artificial Heart Program consists of cardiac surgeons, cardiologists, biomedical engineers, and nurses who work together in treating patients with terminal heart failure with ventricular assist devices (VAD). Under the direction of the VAD engineers collects clinical data and assists with UMMC Artificial Heart database entry. Provides assistance in clinical areas assuring VAD equipment is performing adequately. Performs minor service of biomedical equipment. Assists in monitoring VAD patients....

BIOMEDICAL REPAIR TECHNICIAN III

Job Description: BMET III - Shreveport LA Crothall Healthcare , a division of Compass Group North America, provides customer focused support services. As specialists, we perform services including healthcare housekeeping, management in laundry processing, patient transportation, business facilities management and clinical engineering. Crothall is a compilation of the most committed and talented individuals working in the industry today. Our dedication to quality, exceptional customer service, and unequivocal results allow us to provide the best outcomes to our clients. And, as a member of Compass Group North America, we want you to be as great as you can be. We empower our associates to direct their own future, keeping them confident that we support them every step of the way. As a result, our associates embody greatness through their actions, natural passion for quality, and a can-do attitude. Generous compensation, flexible benefits package, intense training, unrivaled career opportunities, and a shared passion for quality attract the best people to Crothall Healthcare . The opportunity for greatness is real at Crothall Healthcare, and throughout the Compass world. If you are looking for a rewarding career where you can make a difference, Crothall is the place for you. We are looking for energetic, passionate and career minded people to join our team and help grow our business. This is a GREAT OPPORTUNITY to become a leader in a great company and growing corporation. In this position you will be responsible for providing Biomedical engineering, service and repairs on high end Laboratory Equipment at hospitals in your region, including preventive maintenance, and calibrations. Responsibilities: Perform complex repairs and calibration services on a broad range of patient care and support equipment. Perform planned maintenance and electrical safety inspections on range of patient care and selected support equipment in compliance with established standards. Manage equipment and schedule service. Perform pre-acceptance inspections and develop PM procedures on newly purchased equipment; maintains files on procedures and manuals. Ensure test equipment is working properly and calibrated within established intervals. Respond expeditiously to calls from clinical departments to evaluate and rectify valid operator complaints and concerns. Research and initiate orders for repair parts. Provide informal training to equipment users. Participate in the Quality Improvement / Risk Management program and make recommendations for improvement. Provide emergency on-call responsibilities as needed....

BIOMEDICAL REPAIR TECHNICIAN III

Job Description: BMET III - Lexington KY Crothall Healthcare , a division of Compass Group North America, provides customer focused support services. As specialists, we perform services including healthcare housekeeping, management in laundry processing, patient transportation, business facilities management and clinical engineering. Crothall is a compilation of the most committed and talented individuals working in the industry today. Our dedication to quality, exceptional customer service, and unequivocal results allow us to provide the best outcomes to our clients. And, as a member of Compass Group North America, we want you to be as great as you can be. We empower our associates to direct their own future, keeping them confident that we support them every step of the way. As a result, our associates embody greatness through their actions, natural passion for quality, and a can-do attitude. Generous compensation, flexible benefits package, intense training, unrivaled career opportunities, and a shared passion for quality attract the best people to Crothall Healthcare . The opportunity for greatness is real at Crothall Healthcare, and throughout the Compass world. If you are looking for a rewarding career where you can make a difference, Crothall is the place for you. We are looking for energetic, passionate and career minded people to join our team and help grow our business. This is a GREAT OPPORTUNITY to become a leader in a great company and growing corporation. In this position you will be responsible for providing Biomedical engineering, service and repairs on high end Laboratory Equipment at hospitals in your region, including preventive maintenance, and calibrations. Responsibilities: Perform complex repairs and calibration services on a broad range of patient care and support equipment. Perform planned maintenance and electrical safety inspections on range of patient care and selected support equipment in compliance with established standards. Manage equipment and schedule service. Perform pre-acceptance inspections and develop PM procedures on newly purchased equipment; maintains files on procedures and manuals. Ensure test equipment is working properly and calibrated within established intervals. Respond expeditiously to calls from clinical departments to evaluate and rectify valid operator complaints and concerns. Research and initiate orders for repair parts. Provide informal training to equipment users. Participate in the Quality Improvement / Risk Management program and make recommendations for improvement. Provide emergency on-call responsibilities as needed....

BIOMEDICAL REPAIR TECHNICIAN II

Job Description: Crothall Healthcare ,a division of Compass Group North America, provides customer focused support services. As specialists, we perform services including healthcare housekeeping, management in laundry processing, patient transportation, business facilities management and clinical engineering. Crothall is a compilation of the most committed and talented individuals working in the industry today. Our dedication to quality, exceptional customer service, and unequivocal results allow us to provide the best outcomes to our clients. And, as a member of Compass Group North America, we want you to be as great as you can be. We empower our associates to direct their own future, keeping them confident that we support them every step of the way. As a result, our associates embody greatness through their actions, natural passion for quality, and a can-do attitude. Generous compensation, flexible benefits package, intense training, unrivaled career opportunities, and a shared passion for quality attract the best people to Crothall Healthcare . The opportunity for greatness is real at Crothall Healthcare, and throughout the Compass world. If you are looking for a rewarding career where you can make a difference, Crothall is the place for you. We are looking for energetic, passionate and career minded people to join our team and help grow our business. This is a GREAT OPPORTUNITY to become a leader in a great company and growing corporation. In this position you will be responsible for providing Biomedical engineering, service and repairs on high end Laboratory Equipment on site at a hospital, including preventive maintenance, and calibrations. Responsibilities: Perform complex repairs and calibration services on a broad range of patient care and support equipment. Perform planned maintenance and electrical safety inspections on range of patient care and selected support equipment in compliance with established standards. Manage equipment and schedule service. Perform pre-acceptance inspections and develop PM procedures on newly purchased equipment; maintain files on procedures and manuals. Ensure test equipment is working properly and calibrated within established intervals. Research and initiate orders for repair parts. Provide informal training to equipment users. Participate in the Quality Improvement/Risk Management program and make recommendations for improvement. Provide emergency on-call responsibilities as needed....

BIOMEDICAL REPAIR TECHNICIAN I

Job Description: Crothall Healthcare ,a division of Compass Group North America, provides customer focused support services. As specialists, we perform services including healthcare housekeeping, management in laundry processing, patient transportation, business facilities management and clinical engineering. Crothall is a compilation of the most committed and talented individuals working in the industry today. Our dedication to quality, exceptional customer service, and unequivocal results allow us to provide the best outcomes to our clients. And, as a member of Compass Group North America, we want you to be as great as you can be. We empower our associates to direct their own future, keeping them confident that we support them every step of the way. As a result, our associates embody greatness through their actions, natural passion for quality, and a can-do attitude. Generous compensation, flexible benefits package, intense training, unrivaled career opportunities, and a shared passion for quality attract the best people to Crothall Healthcare . The opportunity for greatness is real at Crothall Healthcare, and throughout the Compass world. If you are looking for a rewarding career where you can make a difference, Crothall is the place for you. We are looking for energetic, passionate and career minded people to join our team and help grow our business. This is a GREAT OPPORTUNITY to become a leader in a great company and growing corporation. In this position you will be responsible for providing Biomedical engineering, service and repairs on high end Laboratory Equipment on site at a hospital, including preventive maintenance, and calibrations. Responsibilities: Perform complex repairs and calibration services on a broad range of patient care and support equipment. Perform planned maintenance and electrical safety inspections on range of patient care and selected support equipment in compliance with established standards. Manage equipment and schedule service. Perform pre-acceptance inspections and develop PM procedures on newly purchased equipment; maintain files on procedures and manuals. Ensure test equipment is working properly and calibrated within established intervals. Research and initiate orders for repair parts. Provide informal training to equipment users. Participate in the Quality Improvement/Risk Management program and make recommendations for improvement. Provide emergency on-call responsibilities as needed....

Biomedical Electronics Tech TEMP

In accordance with the mission and philosophy of Dignity Health, the Biomedical Electronics Technician is a professional electronics technician who provides the skills and knowledge necessary to achieve the operational goals of the Biomedical Engineering Department and Sequoia Hospital. The Biomedical Electronics Technician provides a variety of technical equipment maintenance skills including preventive maintenance and repair of diagnostic and therapeutic medical equipment and equipment systems. .A. S. Degree in Biomedical Electronics Technology, electronic technology or the equivalent with four years experience in Biomedical Engineering or completion of vocational/technical training school with four years experience in Biomedical engineering is required. A.A.M.I. certification is preferred. Valid California Drivers License. Sequoia Hospital, a Dignity Health Member, is an accredited, not-for-profit community hospital providing innovative and exceptional health care for generations of Bay Area residents. In 2014, the hospital will celebrate the opening of a rebuilt, state-of-the-art medical campus, including modernized emergency services and an all-new pavilion with three floors of larger, private patient rooms. Recognized for superior and sustained clinical quality, the hospital received the 2013 America's 50 Best Hospitals Awardâ and the 2013 Distinguished Hospital Award for Clinical Excellenceâ from HealthGrades®, a leading provider of comprehensive information about physicians and hospitals. Sequoia's Heart and Vascular Institute is a nationally known pioneer in advanced cardiac care....

Biomedical Engerineering Technician

Biomedical Engerineering Technician309581WashingtonAdventistHospitalFull-TimeRegular Return to Previous Page ResponsibilitiesResponds to service calls to evaluate, diagnose and perform repair and planned maintenance (PM) on biomedical electronic equipment, verifying proper condition and operation. Also provides training to BioMed Technicians and monitors biomedical equipment vendors performing on-site service.Qualifications* A.S. in Electronics, Mechanical Principles or equivalent formal technical training. * Proficiency to independently perform repairs and planned maintenance on a variety of clinical equipment. * 2 years experience as Biomedical Technician, hospital experience preferred. * Effective technical communications skills. * Ability to work independently and also in a collaborative environment. * Strong customer service skills. * Proficient in PC skills in a MS Windows environment. (e-mail, workorder processing, procurement, etc.)Work ScheduleFull Time day shift with on-call service one week each month.Equal Employment OpportunityAdventist HealthCare is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, national origin, age, marital status, disability or any other basis prohibited by law. Return to Previous Page...

BIOMEDICAL ENGINEERING - FIELD SERVICE SPECIALIST III

To provide specialized repair (Radiology, CathLlab, CT, MRI, PET etc.) and maintenance services on Diagnostic Imaging and Biomedical Equipment. Experience: Eight years of related experience. Must have up-to-date knowledge on technological and medical advances. Must have up-to-date understanding of The Joint Commission, CMS, 21 CFR, MDE and NFPA regulations....

Quality Engineer

Quality Engineering About Our Company: With more than25,000 employees globally, ZEISS is one of the leaders in the optical andoptoelectronic industry. As part of the Medical Technology business group youwill work on simplifying clinical and office workflows through innovativesolutions. Products from ZEISS help doctors to diagnose and treat moreefficiently and reliably, and therefore enhance their patients' quality oflife. Carl ZeissMeditec AG, recently acquired, AAREN Scientific, a US-based manufacturer ofintraocular optical lenses (IOLs) and ophthalmic surgical products for cataractsurgery. AAREN Scientific is located in Ontario, California and seeks experienced, highly motivatedindividuals to support the growth and demands within various departments andfunctions. Within our QM/QC department we need; QualityEngineering Job Summary: This individual will p rovideQuality support for Validations, IQ/OQ and PQs creation and Quality processdevelopment and documentation necessary to integrate and maintain products intothe production systems. Plans and coordinates activities to support new productintroductions and process improvements by performing the following duties. ESSENTIAL DUTIES ANDRESPONSIBILITIES : Other duties may be assigned. Document implementation of QM/QC group (SOP?s; ETE?s). Reviews records; Writes procedures for QM/QC group. Support QM/QC document control function Responsible for QM/QC validations, IQ/OQ/PQs, testing and other assigned QM/QC functions Responsible for regulatory agency audit support, QSR maintenance and improvements and creating improving QM/QC documentation Create new documents in-QM/QC implementation Development/optimization of QM/QC processes to improve product quality Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes. Establishes statistical confidence by identifying sample size and acceptable error; determining levels of confidence. Establishes statistical reliability by using mean time before failure, weibull 3-parameter distribution, reliability modeling, and reliability demonstration tests. Develops experiments by applying full and fractional factorial techniques. Develops sampling plans by applying attribute, variable, and sequential sampling methods. Maintains statistical process controls by applying demerit/unit, zone charting, x2 charts for distributions and individual-medial/range for multi-stream processes Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests. Prepares reports by collecting, analyzing, and summarizing data; making recommendations. Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies; maintaining ASQ American Society of Quality Control certified quality engineer qualification. Contributes to team effort by accomplishing related results as needed. Quality Engineering...

Engineer- Medical Device

Seeking ENGINEERS in the MEDICAL DEVICE Industry Multiple positions for the following: Quality Engineer Project Engineer Industrial Engineer Operations Engineer Jr. Engineer...

Healthcare Technology Engineer (Project Officer/Biomedical Engineer)

ECRI Institute is seeking an analytical professional to evaluate medical products and provide technical consultation to the healthcare community. This position is based out of ECRI Institute's Headquarters in Plymouth Meeting, PA. About ECRI Institute: ECRI Institute is a nonprofit organization that researches the best approaches to improving patient safety and care. It has its headquarters in Plymouth Meeting, Pennsylvania. We have a diverse working environment that encourages teamwork and an open exchange of ideas. Over 350 dedicated staff blend extraordinary scope and depth of clinical, management, and technical expertise with a wide range of experienced healthcare professionals. Our competitive benefit package for full-time and benefit-eligible part-time employees includes medical, dental, vision, and prescription coverage which begin on the first day of employment. For more than 45 years, ECRI Institute has dedicated itself to bringing the discipline of applied scientific research to healthcare. Through rigorous, evidence-based patient safety research, ECRI Institute has recommended actionable solutions that have saved countless lives. ECRI Institute is designated an Evidence-Based Practice Center by the U.S. Agency for Healthcare Research and Quality. ECRI Institute PSO is listed as a federally certified Patient Safety Organization by the U.S. Department of Health and Human Services and strives to achieve the highest levels of safety and quality in healthcare by collecting and analyzing patient safety information and sharing best practices and lessons learned. Qualified applicants must be legally authorized to work in the United States. ECRI Institute is an equal opportunity and affirmative action employer and does not discriminate against otherwise qualified applicants on the basis of race, color, religion, age, sex, sexual orientation, national origin, disability or veteran status. If you need a reasonable accommodation for any part of the application and/or hiring process, please contact the Human Resources Department at 610-825-6000. EOE Minority/Female/Disability/Veteran...

Senior Engineer, New Product Development

TITLE : Senior Engineer, New Product Development Department: New Product Development Classification: Exempt Reports To: Manager/Director of New Product Development Date: April 28, 2014 Symmetry Medical is an Equal Opportunity Employer. 41 CFR § 60-1.41 (a) JOB SUMMARY: The Senior Engineer will be responsible for the product design and development aspects of a complex project with a focus on innovative medical devices that address the customer needs for a complete procedural solution. This position is expected to develop an expert knowledge of products and will assist in providing product support to the field as required. This is accomplished by maintaining Symmetry Medical?s principles of Safety, Quality, Customer Satisfaction and Innovations. ESSENTIAL FUNCTIONS: Lead cross functional project teams through all phases of the product development process including planning and product launch. Lead all aspects of the project management functions including scope definition, budgeting, and contingency planning Work closely with project core team (marketing, manufacturing, quality, testing etc) and surgeons to define user needs, generate design concepts and prototypes, and perform design evaluations (such as tolerance analysis, FEA, DOE, simulated use testing etc). Support development of product process validation plans and testing. Collaborate with manufacturing engineering and suppliers to optimize designs for manufacturability and produce prototypes. KNOWLEDGE, SKILLS, AND ABILITIES: Medical device industry Project Management Three-Dimensional Parametric Solid Modeling FDA QSR and ISO 13485 quality standards Quality standards within the company Scheduling work to achieve goals Customer focused environment Business systems and knowledge of impact to business Strong organizational skills Strong people and leadership skills Diplomacy Motivation Teaching/Coaching/Mentoring Excellent verbal, written and presentation skills required. Problem solving and evaluation Process improvements Computer operation; Proficiency in MS Office Suite Project management Streamlining processes Self Motivated Multi-task Speak in front of people in a variety of settings Be flexible and adapt to changes in the market place Interface professionally and courteously with customers/public/internal staff Prioritize work Meet goals and objectives set for department and company Keep current in changing work methods and regulatory changes EDUCATION AND WORK EXPERIENCE A minimum of a BA/BS in Engineering plus 6 years of experience or an MS degree in Engineering plus 4 years of experience is required. Advanced degree is preferred. A degree in Biomedical Engineering or Mechanical Engineering would be preferred. Experience with medical device development is strongly preferred. Previous experience in new product development is required. Must have experience in identifying user needs, device design principles, material selection, ability to verify and validate design concepts, and understand design failure modes is required. Demonstrated understanding of various types of mechanisms, materials, proper tolerancing, drafting standards, design for mold ability and GD&T are required. Demonstrated background in developing creative solutions to solve design problems. Must demonstrate a strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively. Must have experience leading and influencing others without authority, participating on cross functional teams and solid negotiating skills to bring products from concept to launch is required. Must have experience communicating concepts, ideas and knowledge to other individuals, surgeons, customers and/or teams, and work effectively as a project leader. Experience utilizing computer aided design (CAD) to develop a product is required Process experience/six sigma training preferred. PHYSICAL AND ENVIRONMENTAL DEMANDS: Very frequent ? 20 + hours per week: Office environment Production floor Walking Hand dexterity - keyboarding Sight Talking Frequent ? 8 to 20 hours per week: Working overtime Occasionally: Lifting 25 pounds TRAVEL REQUIREMENTS: X YES NO Yes, may require up to 10% travel. INTENT AND FUNCTION OF JOB DESCRIPTIONS: Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions. In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all inclusive. In accordance with Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals. However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose undue hardships on the organization. Job descriptions are not intended as and do not create employment contracts. This organization maintains its status as an at-will employer. Employees can be terminated for any reason not prohibited by law....

Manufacturing Engineering Manager - New Product Introduction

Pioneering Therapies, Transforming Lives. What does it mean to be part of the Thoratec Team? It means working in a fast-paced environment that inspires you. It means collaborating on projects that literally save patients' lives. We have an incredible opportunity for a Manufacturing Engineering Manager to work with our innovative Manufacturing Engineering team in Pleasanton, CA. The Manufacturing Engineering Manager will perform and coordinate a diverse range of complex activities associated with the manufacturing engineering support of existing circulatory support products, development of manufacturing processes and transfer of new products into production. Work will be performed without appreciable direction. He/she will exercise considerable latitude in determining strategic direction of a Manufacturing Engineering work group. The Manufacturing Engineering Manager will manage projects received from internal and external customers relating to sustaining the production line, designing for manufacturability, creating new processes, validation of existing, new or external manufacturing processes and establishing manufacturing systems to drive and improve common work streams. This position will be required to lead a cross functional group of technical experts in the mechanical, electrical, chemical/process, industrial, biomedical or other engineering disciplines to provide best-in-class customer service and responsiveness in completing work. The Manufacturing Engineering manager is responsible for assuring projects are appropriately optimizing performance, scheduling and cost trade-offs. The candidate must have demonstrated ability to manage people and budgets. The candidate will operate collaboratively with Operations Management and their customers including Manufacturing Engineering, Production, Supply Chain, Quality, R&D, Regulatory Affairs, Customer Driven Quality and Marketing. The candidate will represent Thoratec Corporation in a professional manner and project a quality image with the current and future internal and external customers. Responsibilities: This position is responsible for, but not limited to, the following: Leads cross-functional teams and manages projects to plan with high quality deliverables. Presents data to upper management, peers as well as down the organization. Oversees the new product introduction, sustaining, systems and or engineering service responsibilities and functions for Thoratec. Assumes a leadership role in working with R&D project teams to transfer new products into manufacturing. Provides technical support to manufacturing and improve productivity and reduce costs. Provides input and support to Regulatory Affairs for FDA submission and to resolve customer concerns. Provides project prioritization for the group. Projects will vary in duration and across a variety of disciplines, product lines and customers. Communicates status to all projects including issues encountered, resolutions and conflicts to all levels of management. Manages a staff of Manufacturing Engineers and/or Technicians. Selects, develops and evaluates personnel to ensure the efficient operation of the function. Monitors productivity of direct reports and identifies means to assure efficiency and consistency of work. Periodically audits employee?s work activities to assure accuracy of work performed and compliance with GMP and regulatory requirements. Conducts performance and development discussions as needed. Engages and motivates both team and cross-functional relationships. Mentors staff to ensure future growth. Provides guidance and performs various Engineering functions directly or through subordinates including: Developing and validating manufacturing processes, including equipment identification, design, installation and validation for fabrication of products heavily weighted in metal precision machining and electro/mechanical assembly in a clean room environment. Process automation, electronic data control, time flow, rework and process optimization. Design for manufacturability and the ability to work as a part of cross-functional development teams. Developing, releasing and maintaining product assembly drawings, bill of materials, and component drawings in an ISO-9001/FDA GMP design and document control environment. Developing effective fabrication procedures, QA procedures, and process control documents. Establishing manufacturing process flow diagrams and process validation procedures. Evaluating process capability and identify areas for improvement. Collecting and analyzing ?in-process? data to determine areas for process improvement. Leading process improvement projects as necessary. Experience and knowledge in building quality into processes, including process flow and Failure Mode Effects analysis as well as gauge reproducibility and reliability. Stays current with industry best practice and serves as a change agent to introduce effective and efficient practices to the department. Maintains current knowledge of all applicable internal and external standards. Acts as subject matter expert when representing team in cross functional meetings or projects. Negotiates with and supports Upper Management to allocate resources required for completing all approved projects. Establishes , plans and operates within an annual financial budget Promotes a strong culture of Continuous Improvement philosophies by establishing performance metrics for the group and implementing internal processes or tools to demonstrate results Additional tasks will be assigned as appropriate....

UI Design- iOS apps

Start Date : 8/4/2014 End Date : 2/4/2015 CONTRACT ROLE Job Duties : Participates in Design and Code Reviews,Specifies, Designs, and Debugs, and Verifies Medical Applications Software,Participates in Software Requirements Specifications inspections ,Researches Automated Testing Tools and Techniques Details:- Design and develop Apple iOS apps in conjunction with low power embedded sensor interface electronics, next generation display devices, and software tools for supporting development and test. Basic Qualifications:?BSEE, BSCS, or BS Biomedical Engineering ?Minimum 5 years of software design and implementation ?***Minimum 2 years experience in developing iOS apps.*** ?***Experience in UI design*** ?Overall software system architecture design experience. ?Good oral and written communication skills....

Medical Device Design Engineer / R&D Engineer

Engineer Today, Manager Tomorrow A very good client of ours is searching for several Product Development Engineers. Candidates ranging from Junior to Principal levels should apply. This is with a rapidly growing medical device company. The ideal candidates will have a background in Mechanical Engineering. This is a ?hands on? position that involves ?concept to manufacturing? work. Mechanical Engineers with the innovation and work ethic have an excellent chance for advancement as the company continues to expand. Please do not hesitate to apply. - BS, MS, PhD ? Mechanical Engineer or Biomedical Engineer - 1-10 years of experience - Concept to Manufacturing - Innovative, fast moving company - SolidWorks, FEA, GD&T, Fluid Dynamics...

Mechanical Engineer/ Product Development Engineer

Product Development Engineer ? Medical Device *3rd PARTY RECRUITER - CONFIDENTIAL My client is looking for several top Senior Product Development Engineers (2-10 years exp/ Entry Level Ph.D.) with a Mechanical Engineer or Biomedical Engineering degree. This is a strong player in the Medical Device industry (Specializing in Drug Delivery Systems), looking to bring their new products to market through added manufacturing and increased product lines. They are looking for a strong mechanical aptitude as well as a commanding technical knowledge. This position will be requiring ?concept to manufacturing;" demanding innovative problem solving ability. They need everything from TOP BS/MS degree students to several years experience in design of intricate, complex component devices. The candidate will be need hands on" ability and experience with the verification and validation of product designs. The company will consider engineers from any industry but prefers a top tier company and solid work history. (i.e. Boeing 5 years or Toyota 6 years). They are looking for management ready applicants; provided their continuous expansion and opportunity to move up. Salary is among Industry Elite; along with a TIER 1 benefits package/ Relocation Assistance...

Sr Validation Engineers ? Project based - Draper UT

Projects are 4-6 months in length working in a Medical Device manufacturing company located in Draper, UT. Very good likelihood of being extended. To be considered you must meet these minimum requirements: Must have at least a Bachelor?s degree in Engineering: Biomedical, Manufacturing, Chemical, or Quality are highly preferred. Must have 5-7 years hands on experience in with the entire IQ/OQ/PQ/PPQ & TMV process. Must be able to work an onsite schedule of M-F 8am-5pm in Draper, UT. Prior to starting selected applicants must successfully pass a complete background screen consisting of: I-9/Everify, criminal history, employment verification, salary verification, education verification, drug screen. To be considered send resume and salary history to:...

Field Service Engineer MEM

Summary: Perform service work in accordance with established policies and procedures of the HSS Biomedical Instrumentation Department. Works with a high degree of autonomy and may supervise others. Qualifications:...

Supplier Quality Engineer

Overview: This position is responsible for the development, documentation, and management of Supplier Quality Assurance and Control processes as required to support facility/division/corporate quality objectives. This position will act as the Supplier quality consultant to transfer project teams, and will lead projects to resolve supplier quality issues. This position is also responsible to manage the BES-Dymax Material Review Board, to participate in qualification efforts for new suppliers, to monitor and report on supplier performance of existing suppliers, and to perform on-site audits of supplier quality systems. Summary of Position with General Responsibilities: ?Lead the BES-Dymax Material Review board and assist in the investigation of component defects and failures. ?Participate on New Product Development and Project Transfer teams to facilitate the approval and transfer of suppliers into the BES-Dymax supplier management system. ?Assist Materials and Engineering in the selection of new suppliers and conduct qualifications and/or surveillance audits of new or established suppliers to BES. ?Track supplier performance and prepare and issue monthly reports of supplier and material quality performance, issues, and actions. ?Issue Supplier Corrective Action Requests as appropriate in response to detected supplier quality trends, and follow-up with suppliers on root cause investigation and closed loop corrective action. ?Plan and perform component, supplier, and process qualifications including First Article Inspections and the preparation of written test protocols and reports. ?Provide supplier related quality assurance sustaining engineering support to established product lines. ?Work with suppliers to identify and support process and product improvements in support of quality and cost improvement projects. ?Develop quality inspection processes, tests, techniques, tools, and fixtures, and train the production, service, and quality control staffs as needed to perform their respective duties. ?Develop written quality plans, quality inspection and test procedures. ?Create and review Risk Assessments and Rework Plans for component and product related issues including use-as-is and rework dispositions. ?Design and conduct Quality Engineering studies to determine causes of quality non-conformances, initiate changes in process, tooling, product design, etc. to correct them. ?Other duties as assigned....

Electronic Hardware/Engineer

Volt has an exciting full-time opportunity for an Electronics/Hardware Engineer in Bellevue, WA. The ideal candidate will be responsible for the development of mixed signal systems, engineering boards, circuit design, simulation and testing, PCB layout, production and validation, biomedical electronics, device level audio circuits, analog signal acquisition systems or sensors, or related fields. If you have on the job experience in the following areas, please apply ASAP! Semiconductor devices Analog/RF circuits Biomedical electronics Device level audio circuits Analog signal acquisition systems or sensors, or related fields This is a Direct Hire position in Bellevue, WA and is offered through Volt Workforce Solutions - Northwest Engineering . We are among the largest Staffing Companies in the US for contingent/temporary and direct hire placements, and support many of the top rated Pacific Northwest companies....

Associate Mechanical Engineer

Do you: Want to work on technical challenging projects? Crave the opportunity to learn new things? Want to have control over what direction your career turns? Then you should work at Moog, Inc. We are the Medical Device division of Moog - a global organization that operates in 23 countries. Our expertise lies in applying advanced technologies to the precision control of motion and fluids. Underlying this expertise is a set of values and beliefs that guides our actions: we pride ourselves on solving challenging problems that make a difference; we strive to be flexible to our customers? unique needs; we do what we say we?ll do; and we believe close working relationships provide better results. The Medical Devices Group designs, manufactures, and distributes industry-leading enteral feeding, infusion, and post-operative pain management pumps, fluid sensing and control solutions, and surgical hand pieces. We have a current openings for Associate Engineers who have either just graduated with their BS/MS in Mechanical/Biomedical/Chemical Engineering, or if have 1-2 years of experience but just didn?t land at the right company and are looking for the right home. Our culture is based upon mutual trust and respect, and we hire capable people and let them do their jobs. Sound good? Here?s the details: Core Responsibilities: Reporting to the Engineering Manager, this position participates in the design & development of the disposable sets related to enteral feeding and intravenous infusion. The candidate will be involved with tubing set device design from engineering requirements to final validation. The position requires working in a team environment interacting closely with other departments such as Operations, Purchasing, Quality Assurance, Regulatory Affairs, Clinicians, Marketing, Customer support, etc. This position requires working with internal and external partners. This position is located in Salt Lake City Project Management ? Serves as engineering team member for the disposable sets portion of related enteral and intravenous pump design and development projects. ? Conducts feasibility studies, identifies engineering tasks and cost estimates, identify technical risks and mitigations ? Establishes and maintains schedules for own deliverables, including tasks and completion milestones. ? Ensure that product development goals are met. ? Confers with supervisor and/or technical leads on unusual matters, reports at regular interval to project leaders on activities/problems/plans ? Time and project management with the ability to manage multiple priorities. ? Works effectively with designers at contracted companies and affiliated organizations ? Works effectively with designers at contracted companies and affiliated organizations. Technical ? Document and review designs using the established development process, including but not limited to high level design, design specifications, design verification, test specifications, and traceability. ? Work with mechanical, software, and manufacturing teams to reach consensus on difficult system-level tradeoffs. ? System Integration ? Problem Solving and Innovation - Provides root cause analysis and design solutions for system level issues. ? Determines and implements the closure of specific corrective actions. ? Involved with device safety and hazard analysis activities. ? Ensure and create as needed, engineering processes, practices to ensure compliance with various standards and regulatory requirements. ? Work with technicians in evaluating and testing concepts. ? Monitor technology trends such as emerging standards for new technology opportunities. What talents and abilities you will bring with you: ? BS/MS in Mechanical/Biomedical/Chemical Engineering ? 0-3 Years related Project Management experience. Plastics knowledge is preferred. ? Understanding of concept-to-production engineering, including high level design, detailed design, prototype assembly logistics, lab debugging, system integration, design verification, and manufacturing handoff. ? Complete understanding of technical principle, theories, and concepts in the field of engineering. ? Independently determines and develops approach to solutions. ? Excellent communication skills, both written and verbal, enthusiastic, motivated and self driven. Benefits: Moog Medical Devices Group offers a wide range of benefits, including, comprehensive medical and dental insurance at competitive rates, life insurance, short and long term disability insurances, 401(k) plan with a company match, generous paid time off policy for work life balance, on site fitness facility, and the opportunity to work in a great team environment. How to Apply: If you are interested in joining a progressive and fast paced company, and have what it takes to make a positive impact in the lives of the patients we serve, submit your resume via the Moog on-line Career Center located at: www.moog.com . The requisition number for this position is: 14-10835 EOE/AA Minority/Female/Disability/Veteran #CB...

Utility Operator/Stationary Engineer (4396)

The Jackson Laboratory is an independent, nonprofit biomedical research institution and National Cancer Institute-designated Cancer Center based in Bar Harbor, Maine, with a facility in Sacramento, Calif., an institute for genomic medicine planned in Farmington, Conn., and a total staff of about 1,400. Its mission is to discover the genetic basis for preventing, treating and curing human disease, and to enable research and education for the global biomedical community. The Laboratory is the world's source for more than 5,000 strains of genetically defined mice, is home of the mouse genome database and is an international hub for scientific courses, conferences, training and education. The Jackson Laboratory is seeking an experienced Stationary Steam Engineer to join the Facilities Maintenance and Operations team. Our plant is always growing and we are seeking enthusiastic engineers to operate and maintain our complex plant in Bar Harbor while being part of a tight knit crew. Key Responsibilities Include: Responsible for operation and maintenance of a complex and modern high pressure steam plant, chill water plant, and emergency electrical generation to include:Documentation of plant condition, maintenance, and status via equipment rounds, fuel and water meter logs, preventative and corrective maintenance using our CMMS software, and keeping a detailed log book in the control room. Very unique Suspended Wood Powder Combustion 1200hp, 300 psi pellet boiler with a 600kW back pressure steam turbine, 1600hp of LPG fire tube 85 psi boilers with associated vaporizers, and 1500hp of fuel oil fire tube 85 psi boilers. Responsibilities of operation and maintenance of associated supporting plant equipment such as condensate pumps, feed water pumps, steam pressure reducing stations, steam traps, air compressors, and boiler water chemistry amongst others. 5,500 tons of chiller capacity from x4 low pressure units, x2 steam absorption units, and x3 high pressure units including associated supporting plant equipment such as towers, pumps, and water chemistry. 4.25Mw of emergency diesel generation capacity. Documentation of plant condition, maintenance, and status via equipment rounds, fuel and water meter logs, preventative and corrective maintenance using our CMMS software, and keeping a detailed log book in the control room. Working up to personal ability level in other Maintenance trades as a first responder to after-hours facility related issues. Work will require shift work as part of a 24/7/365 operation with occasional required or optional overtime....

PRODUCT DEVELOPMENT ENGINEERS

Must have Med Device experience Must have metals experience Must have a Mechanical Engineering Degree or Biomedical degree Must have design experience with Pro E or Solidworks Designs and develops new implants and instrumentation. This includes communication with surgeons and sales consultants, understanding the clinical issues, defining the design parameters to support AO philosophies, and ensuring the correct product is provided to the customer. Position Duties Include: - Designs and develops new implants and instrumentation and develops improvements and modifications to current products. - Interacts with surgeons, manufacturing, regulatory affairs, sales consultants, product managers, and other functional departments to define and develop product requirements and concepts. - Works directly with surgeons for design concept development, prototype and cadaver evaluation, and clinical follow-up. - Generates product models, concept layouts, and prints using ProEngineer software. Apply geometric dimensioning and tolerancing accordingly. - Performs the required activities and generates the appropriate documents to ensure compliance with FDA Design Control regulations, and to support 510(k) submissions or IDE clinical studies. This includes all Risk Management activities - Develops mechanical test protocols according to ASTM standards and coordinates the activities required to fabricate test parts and complete mechanical testing. - Works with manufacturing during the design stages to incorporate manufacturability into the product designs. - Responsible for all the designs from concept development through product launch. - Responsible for initial patent review of designs for freedom to operate. Experience Required: - Bacheloras degree in Engineering required (BSME or Biomedical are acceptable) - Working experience with ProEngineer or Solidworks is required - Must have experience working with metals in Med Device - Experience within a product development team in the Medical Device industry is required - Familiarity with FDA Design Controls - Must have 3 to 7 yearsa experience in design and development of Medical Device products - This is a ahands ona position...

Engineer 1, Hardware-US - NY - Rochester - CNP

Ortho-Clinical Diagnostics, Inc. (OCD) is a leading provider of in vitro diagnostic products and services, offering accurate, timely, and cost-effective solutions for screening, diagnosing, monitoring and confirming diseases. The company has approximately 3,800 employees around the world serving the global clinical laboratory and transfusion medicine community, and is committed to providing customers with products, services and process solutions to make labs more efficient in delivering the quality test results doctors and patients need. OCD was recently acquired by global alternative asset manager The Carlyle Group as an independent, freestanding company. With new leadership and accelerated investment in research and development, OCD is well positioned for growth as a leading player in the global diagnostics market, tapping into rising demand for sophisticated medical diagnostic products and services worldwide Ortho Clinical Diagnostics a global company, is recruiting for an Engineer 1, Hardware in our Research & Development Organization located in Rochester, NY. The Engineer I, Hardware reports to the Hardware Engineering Manager within the Research & Development Systems function. Participates in Design Engineering Function responsible for development of hardware,designs from concept through transfer to manufacturing as well as significant post-launch design changes for current products. Responsibilities include participating in development of processes, process improvements, and staying up to date with latest design tools and practices. Is responsible to continually improving relevant engineering and leadership skills;conduct or manage deliverables, analysis or processes.Ensures completion of activities balancing quality, cost and time.Demonstrates a strongability to work as a systems engineer. Is responsible for leading laboratory automation development with external manufacturers. Requirements: Requires a minimum of a Bachelors Degree. Applicants who exhibit core competencies in one of the following fields: electrical engineering mechanical engineering chemical engineering biomedical engineering chemistry Requires at least 1 year ofequipment development experience.Medical Device Product Development experience is preferred. Demonstrated ability to work as a systems engineer in a team environment. Excellent verbal, written and presentation skills are required. Must demonstrate a strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively. Experience in identifying and resolving problems for Medical Device instrumentation. Ortho Clinical Diagnostics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law. R&D...

Business Systems Analyst

Our prestigious medical client is in need of a seasoned Business Systems Analyst with extensive experience in workflow and business process design. The Business Systems Analyst will be involved in new development efforts as well as helping to resolve production issues. Day-to-day contributions for this role will include: Working with customers to expose the root cause of issues as opposed to just the symptoms or solutions that the customer describes. The BSA will then use this information so that the team can define a technical solution that maximally addresses the customer needs. Working with the technical team to translate customer's desires into an optimally defined technical solution. Producing clear functional specifications to ensure success and traceability across the development cycle ? design, development, QA and user acceptance. Generates applicable artifacts. Defining information architecture requirements to ensure overall design adheres to best practices for the user experience and implementation. Work with technical team to identify the root cause and alternatives for resolving production systems issues Communicate with the customer to determine a path forward and risk mitigation....

Materials Manager

Under the direction of the Clinical Director, the OR materials management coordinator is responsible for the day-to-day management of the supply procurement and patient billing activities Scrub tech experience a plus Responsibilities: Complies with accreditation and regulatory bodies and commissions in relation to operating room materials management Attends all required safety training programs and can describe his/her responsibilities related to general safety, center/service safety, and specific job-related hazards Follows the center exposure control plans/bloodborne and airborne pathogens Oversees the maintenance of materials management and center records Monitors equipment control including maintenance and repair in collaboration with biomedical engineer Assists in preparation of material and service budgets Collaborates with Clinical Director to negotiate competitive pricing with vendors Develops a system for inventory management Promotes effective working relations and works effectively as part of a center/unit team inter- and intracenter to facilitate the center's/unit's ability to meet its goals and objectives Demonstrates willingness to identify and/or assume activities relative to the developmental needs of the center and the organization Controls operating room inventory Responds to Business Office Manager and billing concerns Develop materials management and patient billing policies and procedures for the operating room region in accordance with center policies and procedures Qualifications: High School Diploma Basic computer skills Good phone etiquette The ability to multi task Excellent organizational skills CPR-AED on hire or within 90 days of hire...

Staff Quality Engineer

Performs quality engineering analysis and synthesis activities in support of projects to develop new products or improve products already in production. Typically will work in small project teams where keys to success will be to respect the ideas of others while having the knowledge and experience to gain team support to ensure that quality and regulatory requirements are met as they relate to design control and change control. This person will also work with cross functional stake holders to ensure overall improvement of product reliability. Responsible for evaluating the scope of new projects, defining and planning for quality requirements; researching or consulting with QA/RA staff to define applicable regulatory and statutory requirements, Ensures that all requirements and deliverables are met during the design control process. Responsible for forming risk analysis teams and leading risk analysis activities on projects as required. The incumbent may complete some risk analyses personally, but emphasis will be on facilitating team efforts. Will generate or assist in the generation of design verification and validation protocols and reports which are clearly understood and are compliant with all applicable standards and regulations. Will have command of an appropriate set of mathematical, statistical and scientific problem solving knowledge to bring to bear on problems encountered. Will serve as a consultant on design control processes to the business to ensure project success. Other Duties and Requirements Verification, Qualification, Validation, Reliability, Root cause Analysis, Process mapping and analysis, Project management, depending on specific function Project Management Skills...

Project Manager

A Project Manager provides leadership to the task force to ensure timely completion of all activities and deliverables during the various stages of multidisciplinary design projects. The project manager is responsible for the technical integrity of the design deliverables as well as management of the project scope of work, project engineering budget, design schedule and client relation management. The projects may vary in size and nature, but are mainly in the area of small to medium capitals works, plant engineering and improvements to mill or plant operations. Besides project execution activities, the project manager takes leadership in the development of competitive proposals which outline and define project scope of work, design deliverables, engineering effort-hour and engineering cost estimates....

Laboratory Automation Support Technician

POSITION DETAILS: Currently, Spectrix Analytical Services, LLC is searching for a candidate for a long term, permanent contract position. The job location is in central Connecticut. Job Responsibilities: Provide support for laboratory automation equipment that implement cell culture and cellular assay processes in the context of target identification, lead optimization and program support. Provide scheduled and unscheduled maintenance on analytical, liquid handling and other general laboratory systems Quality control testing on specified equipment with accurate result reporting Accurate data entry of all support/service activities into the clients Incident Tracking Database Provide scheduled service, cleaning, PM and QC work on Multidrop, Plateloc, Embla, Combi, Biotek and Harvester systems. First line responder to service calls and possible quick repair as well. A person familiar with these systems would be preferred, but training can be provided if needed. Spectrix Analytical Services, LLC is an analytical services company that provides on-site services tailored to its client's needs. The company has provided reliable first-rate services since 1999. Spectrix offers flexible schedules to its employees, including competitive salaries and a committed work environment; the company provides automatic benefits of life insurance, short and long term disabilities. Spectrix is not a placement agency. Optional benefits include health, dental, and a retirement savings plan....

Senior Engineer II, Software

This position is responsible for the implementation of embedded software systems or applications for software enhancements and new products according to defined specifications and existing processes in a team environment to meet business and quality objectives. Execute according to software standards for life cycle, documentation, development methods, testing, and maintenance. (rev. 7/23/12) Experience in real-time embedded software systems, preferably in systems with commercial off the shelf real time Operating Systems such as QNX, RTLinux, LynxOS, VxWorks, Integrity, etc. Experience with the full software development lifecycle, cross-functional leadership skills, experience with more complex systems that include GUI design, low-level driver, and real-time implications. At Terumo Cardiovascular Group, we develop, manufacture and distribute medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass, intra-operative monitoring and vascular grafting. Each year, millions of patients around the world benefit from the use of our products. Our corporate headquarters is located in Ann Arbor, Michigan along with one of our manufacturing sites. We also have manufacturing sites in Elkton, Maryland and Ashland, Massachusetts. Our parent company, Terumo Corporation, is a global medical device manufacturer focused on cardiac and vascular specialties, hospital and home health care products....

Clinical Engineering Manager - Imaging

The Clinical Engineering Manager I leads clinical engineering initiatives to provide superior customer service and operational efficiency by managing the execution of the TriMedx Medical Equipment Management Plan (MEMP) and will manage a large imaging program supporting multiple hospitals within the Detroit area.. This position manages operations on a day-to-day basis, collaborates and maintains positive relationships with customers, works to develop colleagues, and provides a communication channel between hospital executives and the TriMedx Central Office. The Clinical Engineering Manager I also directs Joint Commission inspections and ensures that TriMedx services are in compliance with regulatory standards. This position includes a hands-on service component in general biomedical support....

Associate Quality Engineer

Start Date : 8/4/2014 End Date : 12/31/2014 CONTRACT ROLE. CAN CONVERT TO FULL-TIME Job Duties : Completes Design History File documentation ,Design of Experiments (DOE) and Statistical Process Control (SPC),Develops plans to evaluate process repeatability and stability ,Develops product and process improvements,Participates in procedure writing and review ,Performs deliverable checklist audits ,Performs process and equipment validations ,Reviews product performance data to identify trends,Utilizes FMEA within process development ,Generates documentation for engineering protocols and reports ,Implements quality system improvements Details:- Looking for entry level Assoc Quality Engineer. Previous experience as a Co-op preferred. Preferably the incumbent would have experience creating, reviewing, interpreting & identifying trends w SPC, trend charts & other process control elements as it relates to product complaints, failures, & process data. Secondly, the candidate would have experience assessing risk associated w product failures, & have experience working w customer facing organizations. He/she would support the development, establishment & maintaining of quality assurance programs, policies, processes, procedures & controls ensuring that performance & quality of products conform to established standards & agency guidelines to ensure lasting customer satisfaction....

Windows Systems Engineer

TEKsystems has partnered with a local Healthcare organization to assist in the creation of a massive data warehouse. The team is in need of a strong systems administrator to support the research and clinical laboratory environment (this is one of the environments where the original data sets are collected). He or she will support a wide range of applications, hardware, systems, and biological databases for the research lab. The engineer will interact with the Bioinformatics staff and collaborators as appropriate. The engineer will need to have excellent verbal and written communication skills, along with necessary skills to develop training and support materials for the staff. He or she will also write reports to a high standard on analyses undertaken, and contribute to resulting research as appropriate. The Lab Infomatics Engineer will work closely with the Director of IT, development team, and bioinformatics professionals to establish, configure and support a variety of computer environments. Expect to spend 60 percent of your time doing integration work and maintaining the current technical lab environment. The other 40 percent of the job will include gathering requirements from the end users, listening to scientists, and turning their requests into technical outcomes. Knowledge and experience with LIMS/LIS systems is a huge plus. This administrator will take commercial off the shelve software (COTS) and build custom workflows for the end users. The software is typically on Windows XP or 7 and integrated onto the Windows system. He or she will need to write SQL queries and understand Oracle enough to write stored procedures. There are 2 Linux boxes and Windows 2008 servers. Any experience in a lab or research environment is a huge plus. Candidates from NIH, NCI, or academic research hospitals are strong candidates. Skills Required: * BS or higher in Information Technology, Computer Science, Information Management Systems, or related area * Expert of Microsoft Suite products. Ability to handle basic system administration issues related to Window Server 2008. Experience with Oracle, MySQL, Postgres, etc. * Must be able to communicate technical/complex information both * Ability to establish and maintain cooperation, understanding, trust and credibility * Willing and competent in performing multiple tasks concurrently and responding to emergency situations effectively. Nice to have: * 1-3 years w ork experience in a biomedical lab or other research environment. * Experience in integrating laboratory instrumentation and robots with a LIMS via application programm interfaces (APIs) and web services. * Programming knowledge and experience related to system administration and basic web services. * Proficiency in Perl, Python, HTML and SQL. Exhibits technical know ledge and experience in Networking technologies. Strong report writing experience including Crystal Reports. About TEKsystems: Join TEKsystems®, a leading IT staffing, IT talent management and IT services firm, and get your career on the fast track. We have more than 100 offices worldwide, and we partner with over 6,000 clients and place over 80,000 consultants per year. At TEKsystems, we seek to understand our consultants? skills, goals and interests, allowing us to present targeted job opportunities on a contract, contract-to-hire or direct placement basis. TEKsystems' leadership in the market stems from our sincere and personal commitment to driving the success of our customers, consultants and each other....

Principal Reliability Engineer

Job Description This Principal System Reliability Engineer will join a new product development team working on the development and support of next-generation minimally invasive surgical platform. The overall job of the Principal System Reliability Engineer is ensuring customer satisfaction and overall project success by implementing Design for Reliability Principles throughout the new product development process for a complex system. This position entails working closely with R&D and Quality leads, members of the System Integration and Testing team, and cross-functional Quality Engineers in order to ensure united efforts focused on delivering a safe and effective product to our customers. ? Develops a comprehensive Reliability Engineering strategy and plans for a complex electro-mechanical system comprised of capital, serviceable, reusable, as well as disposable electro-mechanical sub-systems and/or components and software. ? Performs design for reliability engineering tasks for medical device new product development projects including providing input and approval for Reliability and related design verification protocols and reports. ? Prepares reports, charts and diagrams to disclose results and highlight areas for further investigation. ? Performs follow-up investigation to determine product design flaws. ESSENTIAL FUNCTIONS: ? Guides the successful completion of major programs in a key functional role. ? Accelerate Design For Reliability early involvement in new medical device product development ? Contribute to system risk management activities for new medical device product development to be in compliance with ISO 14971. ? Assure compliance with Good Manufacturing Practices and International Standards Organization requirements and promotes continuous reliability growth and overall quality improvement. ? Develop and document engineering test protocols for testing of medical devices ? Develops Design for Reliability requirements. ? Evaluate designs for Design for Reliability requirements. ? Coordinates reliability testing at a system and sub-system level. ? Prepares and maintains Design for Reliability assessment reports. ? Assumes supervisory responsibility as needed. ? Can interpret and effectively communicate technical findings to a broad audience. ? Anticipates and identifies problems of a wide range including those requiring research and or analysis. ? Collaborates with peers to manage the development of appropriate testing to verify product meets internal and external customer requirements. ? Works closely with external testing agencies as needed. ? Analyzes field data to ensure reliability goals are met ? Works on complex technical projects and provides highly innovative solutions that require the regular use of ingenuity and creativity. ? Trains and mentor others in specialized area. ? Contributes inventions, new designs and techniques regarded as advances in the medical device development and technical / scientific community. ? - Qualifications Education Required: BS in a science or engineering discipline Education Preferred: M.S. in Mechanical, Electrical, or Biomedical engineering or related discipline. Minimum Experience: Bachelor's plus a minimum of 10 years relevant experience; or Master?s plus a minimum of 7 years relevant experience in developing complex electro-mechanical and/or robotic systems in a regulated industry. Medical device development experience is a must. Skills/Qualifications/Experience: ? Strong design for reliability and applied statistics knowledge. Reliability modeling experience using Weibull, exponential, and other reliability distribution functions. ? Knowledge of medical device risk management standards, regulations and requirement. ? Knowledge of engineering documentation including test protocols, laboratory notebook entries and reports. ? Knowledge of reliability engineering laboratory equipment and procedures. ? Strong familiarity with medical-device use in a surgical setting ? Solid understanding of system integration principals in a product development environment. ? Knowledge and experience of using DOE methods. ? Must have experience in generating technical documents. ? Experience with tools such Reliasoft and Minitab is preferred. Skills/Competencies: ? Functional/Technical Skills ? Action Oriented ? Self-Development ? Time Management ? Listens & Communicates Effectively ? Problem Solving ? Customer Focus ? Strategic Planning ? Decision Quality ? Organizing ? Creativity ? Drive for Results ? Presentation Skills ? Developing Others (technical) ? Innovation Management About Kelly Services ® Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly ® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis. Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion. [Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter . Download WorkWire ? , a free career and employment resource iPad® app by Kelly Services.] iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc. Since employing its first engineer in 1965, the Kelly engineering specialty has grown to be recognized as a leading provider of engineering resources to customers in such industries as automotive, chemical, defense, electronics, energy, medical device and pharmaceutical. Want more information? Visit kellyservices.com/engineering Connect with us on...

Design Engineer (IRC4037)

The Design Engineer is responsible for collaborating with Product Development/Project Engineers and/or Engineering Services to create designs and drawings for medical device instruments. The Design Engineer will provide solutions to a variety of introductory technical problems under immediate supervision from senior engineering staff. , Primary responsibilities are to: Develop unique or modified instrumentation for clinicians while maintaining compliance requirements Design medical instruments; generate CAD models and engineering drawings using Pro-Engineer software Interface with vendors on technical issues while supervising designs throughout the manufacturing process Gather and incorporate necessary design inputs from field personnel Verify that designs meet functional and performance specifications Effectively interact with interdepartmental personnel and teams, such as marketing, purchasing, and manufacturing to uphold project plans and achieve project objectives Assist Quality in completing First Article Inspection Obtain RFPs from vendors to manufacture a quality product ensuring project timeline and budget are achieved Attend and participate in all team meetings as scheduled Perform other duties as assigned...

Sr. Quality Assurance Engineer (IRC6785)

Provide Plant Quality Compliance support for the following Quality tasks and duties: Introduction and launching of new or improved products and processes into the site. Participate in problem solving teams. Facilitate from a Quality and Quality Engineering and Plant perspective the launching of new or improved products/processes. Writing and coordinating efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product and material specifications, design and development documentation, SOPs, development and task force projects. Facilitates the development, implementation and monitoring of quality programs and policies that ensure that the development, manufacture and distribution of medical products is in compliance with corporate policies, U.S. Food and Drug Administration Regulations, ISO 13485:2003, the Medical Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies., To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Investigate complaints generated from corporate complaints regarding materials produced in the manufacturing facility and/or assigned to the individual. Facilitate the launching of new or improved product/processes, and the transfer of technology from development to commercialization from a Quality and manufacturing perspective. Writing and coordinating efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product and material specifications, design and development documentation, SOPs, development and task force projects. Aid other engineers in the development of statistically based sampling plans for in-process and final testing and inspections, and validations. Work with project teams to develop statistically sound tests for appropriate support of results. Develop, review and approve validations and completion reports for new and existing products, processes and equipment. Provide statistical analysis of the data to support the reports. Ensure that all projects are in compliance with GLP, QSR (including Design Controls), ISO or other applicable requirements. Support the Quality Management Review Process and other reporting requirements with appropriate data/information. Participate in FDA inspections, ISO certifications and surveillance audits and customer audits. Support corporate Regulatory Affairs by providing information for submissions. Identify and implement opportunities for continuous improvement. Interact and coordinate activities with other departments, external vendors and customers. As required, assist or lead in the prompt implementation of non-Conformance resolution, and Corrective and Preventative Actions(s). Aid in the implementation SPC control system with Manufacturing, Quality Control, and other Quality System. Perform other Quality Systems related duties as required....

PSD/Applications Engineer

Business Segment Healthcare Systems About Us GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. Role Summary/Purpose Essential Responsibilities Develop new Magnetic Resonance (MR) clinical application features by working with marketing, customers, internal/external researchers, and engineers. Involved in pulse sequence design, implementation, and feasibility testing in a clinical environment. Conduct statistical/quantitative analysis to improve software quality. Qualifications/Requirements Master's degree, or foreign equivalent, in Biomedical Engineering, Biophysics, Medical Physics, Information Sciences, Electrical Engineering, Computer Engineering or related field is required. One (1) year of academic/research/industrial experience in MR focused on MR pulse sequence development is required. GE will only employ those who are legally authorized to work in the US for this opening. Desired Characteristics GE is an equal opportunity employer, offering a great work environment, challenging career opportunities, professional training and competitive compensation....

Electronic Engineering Technician (EET) Instructor

JOB DE S C R I P TION Position Title: Instructor Department: Faculty Reports to: Program Director Supe rvi ses: N/A Cl a s sification: Salaried S tatus: Exempt I M P O R T ANT N O T E S : Management reserves the right to change or otherwise modify the functions of this job in order to meet the needs of the company. Additional duties may also be assigned. Consideration will be given to make reasonable accommodations for individuals with disabilities. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed hereafter are representative of the knowledge, skills and or abilities required to do this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. P O S ITION OVERVIEW: T e ach t ech n ical su b je c ts t o s tud ents in t h e o ry and la b / s h o p . Our teaching faculty is encouraged to create an educational environment that is stimulating, motivating, safe, and conducive to learning. E SS E N T I AL FU N C T I O N S : Provide for the safety of students and co-workers. Always attend to a safety hazard or potential safety hazard immediately. Prepare and deliver effective lectures/lessons to students. Organize and plan students? lab/shop projects and provide effective ?hands-on training." Listen to students and staff in an effort to resolve conflicts in a prompt manner and establish good communication. Identify students who are ?at risk." Help them or see that they receive the help that they need. Ensure that all classroom/lab equipment is maintained and in good working order. Prepare in advance to see that students have sufficient materials and equipment to complete all classes and lab assignments. Inspect and identify colored wires, color codes, cells, and so on. Listen to students and co-workers in an effort to resolve conflicts and establish good communication. Understand and enforce school rules and policies. Stay current in subject field through personal study, in-service days, and attending workshops or seminars. Keep the curriculum, performance standards, competencies, lesson plans, and tests current with industry needs. Assist in organizing/conducting field trips. Supervise lab/classroom clean-up by students. Perform other work-related duties that are assigned. Must be able to work flexible hours. Must have a valid driver?s license and minimum legal insurance coverage on a personal vehicle. Supervise Lab Assistant. EDUCATION AND EXPERIENCE REQUIREMENTS: 1. A n y o n e o f t h e f o l l o wing as ap p lica b le t o a s p ecific p r og ra m : A Bachelor?s Degree with two years? experience in the subject field within the last 10 years. An Associate?s Degree with three years? experience in the subject field within the last 10 years. A high school diploma or GED with five years? experience in the subject field within the last 10 years. 2. Be o f g o o d r e pu t ati o n s and c h aract e r as d efi n ed by t h e Sta t e o f T e x as a s f o ll o ws: Title 1 9 T e x as A d m i n is t rat i v e c o d e; Ru l es se c ti o n 1 7 5 .1 27 . ? Good reputation" - A p er s o n is c o n si d e red to b e o f g oo d r ep u tat i o n if: there are no felony convictions related to the operation of a school, and the person had been rehabilitated from any other felony convictions; there are no convictions involving crimes of moral turpitude; within the last 10 years, the person has never been successfully sued for fraud or deceptive trade practice; the person does not own a school currently in violation of the legal requirements; has never owned a school with habitual violations, or has never owned a school which closed with violations including, but not limited to, unpaid refunds; or the pe rson has not knowingly falsified or withheld information from representatives of the agency. 3. A pp r ov al b y t h e T e xas Ed u c ati o n A g en c y ( th i s can b e obtain ed i m m ed i a t ely a ft e r an a pp lica n t is h ire d ). 4. A pp lica b le p r o f e ssi o n al li c ense a n d /o r cre d entia l s. For E xa m p l e: A S E C ertifi c ati o n s in A u to M echa n ic s , Ci t y licenses a n d ARI in r e fr ig e r ati o n HV A C, C M A , H I T, CC S , CCSP o r R M A in M ed i cal A ssisti ng , CET in El e ct r o n ics, AWS in W e l d i ng . In m o st cas e s th i s is n o t a r eq u ir e m e n t to b e h ire d ; ho w e v er, it is a req u ir e m ent f o r c o n t i nu ed e m p l o y m ent. W TI hel p s n ew e m p l o y e e s o b tain t h e n ec e ssa r y c r edenti a ls an d/o r licenses. K N O W LE D G E, SK I LL S , A N D A B I L IT I ES R E QU I RED: Ability to read, write, speak, and understand English fluently. Str o n g v erb a l a n d writ t en c o m m un icat i o n skills, p l u s a n aly t ical, o r g a n i z at i o n al, i n t e r p ers o n al, a n d p r ob l e m- s o lving s kills. Must be customer service oriented. Ability to meet or exceed the company?s attendance and punctuality standards. Ability to evaluate objectively, fairly, and consistently. Creativity and initiative. Ability to correctly use and demonstrate all regular equipment and tools within the subject field. PHYSICAL REQUIREMENTS: Color vision Hearing Lifting or pushing up to 50 pounds Must stand up to 5-6 hours per shift. Ben d i n g at the wai s t, si t t i ng , kneeli ng , l a y i n g h o ri zon tally, cl i m b i ng , wa l ki n g , and so on, as req u ired f o r the l ab o r classr oo m d e m o n strat i o n . Must be able to travel locally and out of town. Manual dexterity E N VI RO N M E N T AL C O N D IT I ONS Extreme heat or cold. Fumes such as from soldering, welding, automotive exhaust and/or air conditioning equipment. Noise level which may, at times, require normal hearing protection in the form of ear plugs. Exposure to machinery and moving parts. Heights (R/HVAC instructors/lab assistants only). Electricity Lubricating fluids, cleaning solvents, batteries, and so on Bio-medical waste such as hypodermic needles, body fluids, cultures, specimens, and so on (Medical/Clinical Department only). The above Job Description is not intended to be an all-encompassing list of responsibilities, skills, efforts, or working conditions associated with this position. It is intended to be a guideline reflecting the principal activities. I do hereby certify that I have read and understand the above job description. I also understand and agree that W e s tern Technical College has the right to change or otherwise modify this job description at any time. Si g nature/Print Name Date...

Research Engineer

MED Institute, Inc. is currently accepting applications for a Research Engineer to become a part of our growing Product Discovery team. The successful candidate will support and lead research and development of novel medical devices. The candidate will work within an interdisciplinary team of engineers and scientists evaluating novel design concepts for new medical products and will also be expected to independently formulate new concepts and produce prototypes. Familiarity with a variety of medical device materials would be advantageous. Responsibilities Collaborate with and lead interdisciplinary teams of scientists and engineers to discover and develop novel medical devices; Develop methods for prototype device fabrication; Take a ?hands on? approach to fabrication of concepts and prototypes; Research new technologies and integrate new capabilities into the product development team; and Lead and assist in the development of experiments, execution, analysis of results, interpretation and reporting of results; Identify problems and propose + develop approaches for solving them. Essential Qualifications MS, or PhD in Engineering (Mechanical, Biomedical, Materials, etc) or a related field; Experience with medical devices is strongly preferred; Experience working in and leading multidisciplinary teams is beneficial; Must be highly flexible, have a hands-on approach and be willing to take the initiative; and Ability to communicate well through written and verbal means is required....

Engineering Technician

This is going to be a 1 year contract assignment Job Summary: Assemble, troubleshoot, repair, test, calibrate and maintain electro-mechanical equipment and systems used within company?s Transplant Diagnostics Serology, Production and Plastics departments and in the biomedical laboratories of its customers. Inspect and/or test electronic and mechanical parts and components to drawing tolerances and written specifications. Ensure continued internal and external customer satisfaction with products by providing high quality and timely assembly, service and repair of electromechanical systems and products. Duties and Responsibilities: Assemble and Test Electromechanical Systems (Lambda Dots, Jets Scans etc.) Pull parts and components from raw materials inventory. Assemble and test electromechanical systems utilizing written build instructions. This includes such tasks as building and testing wiring and cable assemblies, soldering, bench top mechanical assembly, full functional testing and recording of test and inspection results on quality control records, downloading software programs to EPROMs and packing. Order Filling: Pull and package parts, accessories and equipment from stock. Deliver ordered goods to Shipping Department and process associated paperwork. Record keeping and Goal Setting: Use time management and time planning techniques to set milestones and goals for all relevant projects as requested by the engineering manager. Keep an accurate running log of daily time usage, by project, as directed by engineering manager. Skill Requirements: Basic working knowledge of bench top electromechanical assembly, troubleshooting, repair and testing techniques. Working PC skills including Windows, Outlook, Word, and Excel. Procurement & inspection of incoming materials: Apply general sourcing skills, request quotes, and submit purchase requisitions to procure required parts, tools, and materials. Inspect incoming material and document inspection results per established departmental procedures. Participate in departmental quality initiatives: Complete assigned tasks within assigned deadlines Provide input during all stages of 5S implementation: design, process review and modification, ordering supplies, workshops, analysis, report generation, etc. Sustain 5S results by following applicable principles of m...

Principal Design Quality Engineer

The Principal Design Quality Engineer is responsible for creating and implementing the Risk Management File, demonstrating statistical expertise, and injecting the voice of quality to assure quality and compliance for New Product Development (NPD) teams. This position is a hybrid between a traditional R&D Engineer and a traditional Quality Engineer. Essential Duties and Responsibilities ? Represents Quality Assurance on the New Product Development (NPD) cross-functional team (CFT). Interfaces among multiple departments and teams such as R&D, Regulatory Affairs, Advanced Operations, and Marketing to ensure specific product development metrics are met. ? Plans and leads intra-divisional initiatives. ? Creates and implements the Risk Management File for an NPD team. ? Leads Risk Management activities for an NPD team, including identifying hazards and harms that may be associated with the medical device. ? Leads Design Reviews for NPD teams to ensure design and process robustness and compliance to Corporate and Divisional design control procedures. ? Leads the exercise of understanding the functional inputs and outputs of the medical device. ? Plans, designs, and /or implements complex methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment. ? Analyzes reports and recommends corrective action. ? Plans and develops complex process and product protocols and monitors progress. ? Broad knowledge of applicable regulations and standards (e.g. QSR, ISO 13485) and how to apply the principles, practices, and procedures ? Provides and/or reviews advanced statistical techniques for test sample size determinations. ? Uses and/or reviews advanced statistical rationale to plan, analyze, and interpret engineering test data collected during new medical device testing. ? Plans, leads, monitors, and/or controls progress of complex projects to ensure sound application of engineering principles are used, and design intent is being achieved. ? Plans, selects, analyzes, designs, and/or improves complex manufacturing procedures and engineering systems for medical devices. ? Plans and verifies that new complex engineering devices are technically sound and in compliance with FDA and other regulatory bodies. ? Plans, performs, and reviews complex engineering risk analyses to manage technical difficulties encountered with new medical devices. ? Provides leadership in the product development process by identifying effective test methods. ? Provides leadership and influence among multiple departments and teams such as R&D, Regulatory Affairs, Operations, and Marketing to ensure specific product development metrics are met. ? Leads and/or facilitates periodic design reviews during the product development process. ? Plans, improves, and/or supports complex processes. ? Possesses and applies comprehensive knowledge of particular field of specialization to the completion of complex assignments ? Demonstrates technical leadership as an inter-departmental resource. ? Provides leadership and mentoring to more junior staff. ? May interact with customers to solve complex product quality issues and /or answer general product questions. ? May work with verbal and/or written instructions. ? May train others in quality assurance / GMP related topics. ? May direct and/or evaluate the activities of one or more Design Quality Engineering technicians, Associate Design Quality Engineers, Design Quality Engineers, Sr. Design Quality Engineers, Staff Design Quality Engineers, or Sr. Staff Design Quality Engineers....

Field Engineering Specialist ? Medical Instrumentation

Field Engineering Specialist - Medical Instrumentation Do you enjoy working with your hands and with people as a Field Engineering Specialist? Do you enjoy being recognized as the ?go to? or technical expert? Do you have current work experience installing, training and maintaining analytical instrumentation? Are you complimented for your diplomacy skills and cooperative attitude? When everyone else?s hair is on fire, are you able to remain relaxed and patient? Are you comfortable working in a dynamic environment? Are you able to change direction and priorities quickly, based on new information? Are you looking for a small and dynamic company that is growing? Do you want a position that offers visibility and the real opportunity to contribute ideas for new products and product updates? Are you ready to make a change now? If this describes you, please read on: we want to fill this position in the next week! Accountabilities & responsibilities Provide customer support through the performance of on-site installation, as well as overseeing any necessary diagnoses, troubleshooting, service, and repair of complex equipment and systems. Interface with company personnel on new product design to include testing, implementation, installation and support of software, instrumentation, and applications. Evaluate and approve operational quality of system equipment. Document and address customer complaints following FDA guidelines. Ensure field service reports are closed in a timely manner. Support the Sales Team. Facilitate, coordinate, or conduct technical training as needed. Give presentations and/or demonstrations to a variety of audiences. On-call support may be required. Location Boston, MA Compensation The compensation package for this position is dependent upon experience and consists of a competitive base salary plus benefits and the tools necessary to be highly effective in the position. Company information Our client provides molecular-technology solutions. The company develops assays and reagent systems that provide quantitative gene expression analysis in formalin-fixed paraffin embedded tissue (FFPE). The company offers endogenous control assays that are used to identify a set of normalization genes for a custom assay, to mitigate bias when an endogenous gene is over-or under-expressed, or to predict gene expression levels across various tissue types prior to testing on an assay; human, rat, or mouse microRNA gene markers plus clinical trial support, and ingenuity IPA data analysis services to pharmaceutical clients. In addition, the company provides automated instrumentation designed for clinical and research laboratories that offer nucleic acid extraction-free gene expression results from FFPE tissue and various other sample types....

CAD Technician

Advanced CAD Technician needed for a long term (1 year) contract opportunity with Yoh's client located in Brea, CA. Top Skills You Should Possess: CAD Drafting experience with SolidWorks and Unigraphics Technical Bachelor's Degree with a year experience or equivalent experience What You'll Be Doing: Advanced Technician Engineering is proficient with the Computer Aided Design software (SolidWorks) and helps assist with the design and integration of the parts and modules within the instrument design. Conversion of Unigraphics drawings to SolidWorks This position is responsible for maintaining assembly, part and detailed drawings associated with the instrument design. This position is responsible for creating complete assembly models, bills-of-materials, part models and completed drawings. Responsibilities include: Mechanical design of milled, sheet metal, and molded parts using SolidWorks software; Create part models and detailed drawings; Create and maintain module level assemblies and their bill-of-materials; Create documentation to control the release and revision control of drawings (DCO's); Maintain and usage drafting and modeling best practices; Monitors policies procedures and standards relating to hardware development group; Provides timely feedback when roadblocks are not easily overcome. Person will be responsible for documentation and coordinating the implementation of product documentation release, maintenance and the associated electronic data. Creates documentation from CAD system and insures appropriate approval and release process. Organizes and tracks design support activities ensuring completion on schedule and meeting customer needs. What You Need to Bring to the Table: Experienced with creating and maintaining detailed component leveldrawings that include material specifications, material coatings, tolerancing and GD&T. Experienced with software such as e-mail, MS Work, and Excel. Self-starter, sense of urgency to resolve issues and completes assigned tasks. Good written and verbal interpersonal communication skills. SolidWorks experience. Two (2) year technical degree - preferably in Drafting/Mechanical Design. At least one of year of industry experience. Ensures product documentation is created, updated and is in compliance with company standards, ISO and GMP as required. Medical Device experience is desirable. Ability to use Solidworks and familiarity with cad management software SmarTeam or Enovia. Knowledge of drawing requirements and use in CAD system Knowledge of Medical Device documentation requirements (GMP, CFR 820, ISO) Technical Bachelor's Degree with a year experience or equivalent experience. Strong communication skills with the ability to work in a multidisciplinary team environment. What's In It For You? Our client develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Their diagnostic systems are found in hospitals and other critical care settings around the world and produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Be a part of this team! If This Sounds Like You, Apply Now! Recruiter: James Dangler Phone Number: 585-327-7475 Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here! Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. J2W: ENG...

Principal Design Engineer - Medical

EXCITING OPPORTUNITY IN NORTH HOUSTON, TX!!! SUMMARY GKA is currently hiring for a Principal Engineer/Project Manager to work for a leading company that develops, manufactures, and markets (plastic injection molded) medical devices to customers throughout the world. This opportunity is available due to rapid growth, and will lead and mentor engineering personnel in support of the development of new products. There will be also be a variety of hands-on design functions involved, along with overall project management of the program. ESSENTIAL DUTIES AND RESPONSIBILITIES Manages, trains and directs the activities of engineering personnel. May have technicians reporting directly. In project management, responsible for establishing and executing project timelines and budgets. Responsible for the design and development of new products and processes by applying engineering knowledge. Responsible for deploying skills for the purpose of tolerance analysis, fluid flow modeling, structural integrity and mold flow analysis. Responsible for the application of injection molding, machining processes, systems integration and design of tooling/fixturing required for design concepts utilized for new product development. Responsible for generating comprehensive protocols for analyzing, verifying, and validating new products. Works concurrently with the molding group regarding component design, in order to facilitate design for manufacturing. Will interface with manufacturing to apply Lean Manufacturing techniques. Responsible for translation of customer input into designs and subsequent product specifications. Assists in the identification, evaluation and implementation of new suppliers into the company system....

Project Engineer

PROJECT ENGINEER - SAN RAFAEL APYING $100-$150K DOE Looking for a Project Engineer with successful FDA submissions! Medical Equipment Industry BASIC FUNCTION - Project Engineer Coordinates and conducts research and development and technical studies which will lead to new or improved products under specific marketing, cost, time and regulatory constraints. RESPONSIBILITIES - Project Engineer: Will determine specific project related processes and development schedules to meet pre-determined goals and objectives. Will monitor and control progress of projects to ensure sound application of engineering principles are used and design intent is being followed/achieved. Coordinates with other units, vendors and senior managers as needed to ensure specific cost, time and/or regulatory standards are met. Will evaluate final results of project and provide manufacturing guidance/assistance as needed. May participate in the prototype assembly and/or design of sub- or final assemblies of assigned products. May train others on functional area related topics. Will submit periodic reports on assigned topics to appropriate personnel. Will have personal contact with customers. Employee has the necessary authority to execute above mentioned job responsibilities, and will have authority to carry out specific responsibilities defined by quality system documents. Employee has authority to recommend and initiate preventative and correction action with regard to product non-conformances and quality system activities. SUPERVISORY RESPONSIBILITIES - Project Engineer: May coordinate the activities of one or more exempt and/or non-exempt employee. May provide feedback on the performance of 1 or more employees based on pre-established performance parameters....

Quality/Process Engineer

Job Classification: Full-Time Regular Connect confidentially with MRIGlobalMedDevice at: This is a visible position and is a great opportunity to make your mark. This organization is positioned for huge growth and this is a ground floor opportunity to make a tremendous impact in the company?s future. Essential job responsibilities include, but are not limited to: Provides quality and process engineering expertise to the organization while ensuring conformance to the quality management system (QMS), FDA and international regulations, and applicable standards. Assists cross-functional teams with the development of new products and the maintenance of existing product lines. Establishes and implements process improvement projects to drive customer satisfaction, maintain an effective QMS, and improve business productivity. Drives validation projects and documentation, develops and revises QMS documents, reviews validation and production reports/records. Implements a global manufacturing footprint as warranted by evolving customer demands worldwide....

Mechanical Engineer - Cook Inc

Medical Product Manufacturing Since 1963, Cook Group companies have been among the leaders in developing healthcare devices that have improved lives around the world. COOK remains at the forefront of medical research and worldwide sales of products for endovascular therapy, critical care medicine, general surgery, diagnostic and interventional procedures, bioengineered tissue replacement and regeneration, gastroenterology and endoscopy procedures, urology, and obstetrics and gynecology. COOK is a global company with a global focus - and a global future. General Job Description The Engineer develops new products, solves engineering problems and completes projects to meet company objectives for a range of medical device products and processes to advance the strategic goals of the company. Job Functions/Duties (may include other duties as assigned) Develops new products as a member of the Engineering department following 21CFR and ISO standards. Utilizes engineering knowledge and technical expertise to create new designs from components through finished devices. Conceives new manufacturing processes and implements into manufacturing. Completes projects consistent with corporate and departmental objectives by engaging the efforts of other engineering, manufacturing, regulatory, quality assurance, and marketing staff. Contributes to the intellectual property of the company via invention disclosures and patent applications. Prepares and maintains accurate documentation of concepts, designs, drawings, and manufacturing processes consistent with the requirements of pertinent regulations and Cook?s Quality Management System. Maintains and increases technical, medical and biomedical development knowledge related to the company?s product lines. Work Experience 2-5 years experience in Engineering or Life Sciences. Experience using analytic skills and problem solving. Experience in communication and working with a wide variety of associates. Experience working independently and with minimal supervision. Education BS in Engineering or relevent Life Sciences degree. Microsoft software, e.g. MS Project, Excel, Word. We are proud to be an equal employment opportunity employer for men, women, protected veterans and disabled individuals. We maintain a drug-free workplace and perform pre-employment substance abuse testing as permitted by law....

Software Quality Engineer III

. Software Quality Engineer III needed for a four (4) month contract for a manufacturing company in Gainesville, Florida paying up to $41.30 per hour! Summary: The major purpose of this position is to lead the QA/RA Design Control activities related to the New Product Development and necessary on-going activities required to support existing products. The position will work to improve and maintain the standards utilized in the product development and related activities. Ensure that software developed by or for the company meets all applicable internal and external quality and regulatory requirements consistent with its intended use. Lead software risk management activities. Represent quality on product and process development teams ensuring quality procedures and regulatory requirements are met throughout the development process. Duties and Responsibilities: This position is responsible for providing Software Quality Assurance (SQA) engineering support for all lifecycle phases of commercialized software products. Assume subject matter expert position on NPI process, and conformance to regulatory requirements. Ensure new product development is in compliance with medical device regulations and internal procedures. Ensure new products meet customer requirements and specifications. Direct all activities necessary for the project team to achieve design control deliverables, specifically deliverables related to product safety, risk management, and performance. Actively participate in and/or facilitate the development of deliverables required for medical device product development. Provide interpretation and guidance on various SDLC methodologies. Participate in department quality improvement initiatives and actively apply software QA methodology standards in product development. Collaborate with Product and project management teams on system-related enhancements as well as issue resolution. Proactively escalate issues and risks appropriately through proper channels. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Serve as subject matter expert for quality related issues for software products. This individual guides product development teams on efficient and effective application of design controls. This position is responsible for providing Quality Assurance engineering support for all lifecycle phases of commercialized products. Assume subject matter expert position on NPI process, and conformance to regulatory requirements. Ensure new product development is in compliance with medical device regulations and internal procedures. Ensure new products meet customer requirements and specifications. Direct all activities necessary for the project team to achieve design control deliverables, specifically deliverables related to product safety, risk management, and performance. Actively participate in and/or facilitate the development of deliverables required for medical devices Knowledge/Skills/Abilities: Minimum of 3 years related experience in quality assurance or engineering in medical device, bio-tech or other highly regulated or process-driven environments (e.g. aerospace, defense). Strong working knowledge of various Software Development Life Cycle (SDLC) models. Working experience with quality systems, USFDA Quality System Regulation, and / or other mature regulatory or process models. Knowledge of software risk analysis. Test methods and concepts exposure including: exploratory testing, regression, stress, and load testing, and black-box and white-box testing Good organization and communication skills and able to prioritize workload Ability to work successfully in a dynamic, fast paced, high-pressure environment. Experience in imaging technology preferred. Experience/Education: Bachelor?s degree in computer science, biomedical engineering related field or equivalent education and experience. 3 years experience in Software Quality Assurance and/or Software Testing Excellent problem-solving skills and ability to execute. Excellent written and verbal skills. A minimum of three years of experience in software development, and/or systems qualification in a regulatory environment. Formal training in software development preferred Certification in Quality or Software Quality preferred QUALIFIED CANDIDATES APPLY NOW!!! Equal Opportunity Employer Minorities/Women/Veterans/Disabled Only local candidates will be considered as no relocation or per diem is available. Candidates must be able to successfully pass a background check and drug screen. Salary based on experience. Candidates must apply through the "'Apply Online"' function for consideration, or create a profile at www.AdeccoUSA.com then attach your resume to this positing. Qualified candidates will be contacted for interview. NO PHONE CALLS, PLEASE. If you are interested in industry specific articles and news about Engineering & Technical please visit our Facebook page at http://www.facebook.com/pages/Adecco-Engineering-Technical/13825422252?ref=mf and become our Fan....

Injection Molding Process Engineer

Job Classification: Full-Time Regular Connect confidentially with MRIGlobalPlastics at: This manufacturer of high quality plastic products has been successfully exceeding the needs of its customers for over 100+ years. As a respected leader in their industry, this organization really believes in its employees and proves it with excellent compensation, great benefits and a supportive atmosphere where a person's input and efforts are truly appreciated! Key Duties and Responsibilities would include, but not limited to: This Process Engineer will be responsible for effectively leading a number of activities involving injection molding process development and manufacturing deployment of existing and new engineered thermoplastics products. This position requires this Engineer to use their knowledge/experience of thermoplastic materials and analysis techniques to select, develop and optimize manufacturing methods and molds. They will work closely with cross-functional Engineering & Production teams to define and communicate equipment capabilities, evaluate new opportunities, and provide technical troubleshooting and solutions to manufacturing challenges....

Embedded Software Engineer w/ Bluetooth or BLE

Embedded Software Engineer w/ Bluetooth or BLE Develop application firmware for Continuous Glucose Monitoring products. Design and develop firmware for low power embedded sensor interface electronics, software for next generation display devices, and software tools for supporting development and test. RESPONSIBILITIES: Interpret, understand and provide feedback on software requirements for a project. Perform requirement analysis to determine completeness and compliance with software system. Ability to work with requirement management tools. Responsible for delivery of high quality code for a subsystem or project. Code is consistently well-documented and maintainable. Use appropriate tools to support code development. Perform all aspects of software development, including specification, design, and implementation of embedded and PC-based software per our client Diabetes software development procedure. Write and execute comprehensive unit and integration tests to meet quality expectations. Understand appropriate verification practices and tools. Support Hardware/software integration and software validation....

Sr. Product Development Engineer

Job Classification: Full-Time Regular Connect confidentially with MRIGlobalMedDevice at: Our client is a medical device organization located in eastern Tennessee. They have a critical need for a QA/RA Director so this is a great opportunity to make a strong impact and add immediate value. There is a strong team environment and great growth potential within the organization. Relocation assistance provided if necessary. Essential job responsibilities include, but are not limited to: Initiates and monitors the entire design process. Ensure that EN-13485 and FDA GMP Design Control requirements are adhered to per the Quality Manual. Prepare Capital Expenditure Requests as needed for new projects. Prepares detailed component and product drawings on CAD (Computer Aided Design). Directs and coordinates manufacturing or building of prototype products, if necessary. Creates and maintains ?Design History File? for all engineering projects. Analyzes test data and reports to determine if design meets functional and performance specifications. Participates in new product development teams and product launch teams to facilitate the introduction of new products. Applies engineering theory and problem solving techniques to address product deign, mechanical, and fabrication issues....

Product Development Engineer (IRC4659)

Product Development Engineer (IRC4659) Department Description Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery. Integra's orthopedic products include devices and implants for spine, foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair, and wound repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices. Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 3,000 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART." Brief Description The Product Development Engineer is responsible for developing new medical device systems from feasibility to prototype, through market introductions and field support in accordance with FDA and ISO requirements. The Product Development Engineer will provide solutions to a variety of technical problems under general supervision from senior engineering staff. Detailed Description Primary responsibilities are to: Design medical implant and instrument systems, generate CAD models and engineering drawings using Pro-Engineer software Maintain existing products with design and drawing revisions following standard operating procedures Interface with vendors on technical issues while supervising designs throughout the manufacturing process Support Design Control related activities and creation of other documentation Generate and analyze test data and reports to determine if designs meet functional and performance specifications Effectively interact with interdepartmental personnel and teams, such as marketing, purchasing, and manufacturing to uphold project plans and achieve project objectives Assist in the creation of inspection criteria Assist with field sales support and training Attend and participate in all team meetings as scheduled Perform other duties as assigned...

Field Sales Manager

A well-known, Kalamazoo-based manufacturer of fluid power controls is looking for a Field Sales Manager. This position is responsible for the development and management of the outside sales staff. Responsibilities include obtaining profitable results by developing the sales team and ensuring revenue/profit maximization through business development. This position also must collaborate with the sales & marketing director in establishing realistic goals for the department and company. This position requires 50% of travel by plane or car within the US and may require some international travel....

Principal Modelling Engineer

Position: Principal Modeling Engineer ? FEA, CFD Our client: is one of the top 4 oil and gas service companies (multi-billion dollar corporation). They have multiple R&D departments. This particular is a part of the Managed Pressure Drilling Group ? one of the most profitable divisions in the company. The group supports engineering, programming and software development by creating applied mathematical modelling. It provides modeling and simulation support to all product lines globally. R&D is the bread and butter for this company?s business. That is why their strategy is to keep coming with fresh ideas, which is easier to support by bringing professionals from other industries into the oil and gas sector. This hiring manager impressed me multiple times doing just that ? bringing folks from bio-medical, automotive, airspace into his team. Location: Houston, TX. Relocation package offered within the US Industry: Oil and Gas, R&D Reports to: Modeling Manager Sponsorship: No. Only US Citizens and Permanent Residents. Job Description : Modelling Engineer will be supporting modeling needs of MPD product line globally within the company. The perfect candidate is very strong with applied mathematical modeling and can write complex engineering software using modern programming languages. Duties : Use commercial FEA & CFD packages to validate proposed / developed numerical models Benchmark analytical, empirical and numerical models and work with software development team to integrate them into company engineering software Research, select, implement and validate appropriate numerical methods to solve various engineering problems Analytical and numerical modelling in the area of expertise (non-linear dynamics and vibration for downhole drilling, hydraulics or coupled hydro-mechanical systems, geo-mechanics and rock mechanics for drilling applications Implement analytical or numerical models into prototype software using software development tools like C++, C# Document numerical models and maintain internal knowledge base and theory manuals Assisting in coding, testing, debugging new modelling software or making enhancements to existing software Building and solving models of various complexities under strict time constraints Publish technical papers and Articles Acting as a liaison with other modeling and simulation R&D centers our client has globally Requirements : Masters degree or higher in Engineering, preference is given to (a) Mechanical, Petroleum or Chemical Engineering; (b) Physics; (c) Geology or Geosciences; (d) Mathematics ? in that order Strong background in analysis and mathematics Understanding of basics of modern programming such as C++ or C# required. Ability to write complex engineering software preferred. 10+ years of experience background after graduating from a university with a Ph.D. or 15+ with MS Hands-on experience with major commercial FEA and CFD (Abacus, ANSYS, Fluent). Experience in defining, identifying and recognizing how to organize components in numerical model. Describing components in a way for others to understand and be able to reproduce the process Excellent verbal and written communication skills Must be a team player and able to get along with individuals from other groups in the organization The company is not willing to sponsor candidates for this role. Only US Citizens and Permanent Residents will be considered....

Senior Electrical Engineer/Manager - Robotics

Senior Electrical Engineer / Manager | Robotics Northeast The Sr. Electrical Engineer / Manager will be responsible for the reliability, design, technical oversight, and development of the electrical systems and subsystems for a surgical platform utilizing multi-modal flexible robotic technology in an entrepreneurial environment. The position will entail working both hands-on with the systems and subsystems themselves and guiding overall strategy for a multidisciplinary team, including both systems and electrical engineering disciplines. Position Responsibilities: Management of a multidisciplinary robotic product development team Develop and implement product operational performance guidelines Ensuring QA and RA requirements are met (FDA and EU) Providing technical overall guidance in the following: Optical Engineering / Image Processing Mechanical Design System Integration Product Life Cycle Support / Maintenance Transitioning from Prototype to Products Keywords for this Title Include: Electrical Engineering Manager, Electrical Engineering Lead, Lead Electrical Engineer, Lead Systems Engineer, Systems Engineering Manager Keywords for this Position Include: Digital, Motion Control, Image Processing, Medical Device, Robotic, Navigation, Electrical Engineering, Image Capture, Optics, Optical, Embedded Systems, Surgical Robotics, Electro-mechanical, IEC 60601 Prior experience with the following or similar companies is helpful: Mako, Acclarent, Intuitive Surgical, Stereotaxis, Vital Images, Hansen Medical, IMRIS, Perfint, InTouch Health, Mazor, Robosoft, Mobile Robotics, Denso Robotics, BioFlex, MRI Robotics, Health Robotics, Accuray, CyberHeart, Device Technologies, Immersion Robotics, Restoration Robotics, Interactive Motion Technologies, Flir, Computer Motion, Analogic, Boston Scientific, Elekta, Covidien, Konica Minolta, Styker, Argo Medical Technology, Cyberdyne, Hocoma, iWalk, Kinea Design, Myomo, Ossur, Otto Bock Healthcare, Parker / Hannifin, Rex Bionics, RLS Steeper, Tibion, Titan Medical, Touch Bionics, Victhom Human Bionics NOTE: This job description is not intended to be all-inclusive and may have been abbreviated or maximized for online or mobile viewing. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization....

Principle Design Engineer

Maple Grove, MN - The Principle Design Engineer will be directly responsible for designing single use electrosurgical medical devices. The incumbent will be able to design complex precision mechanical mechanisms, fluid seals, injection molded components, thermo-formed components, which can be manufactured in high volumes and are highly reliable. EOE M/F/D/V...

IVD Systems & Verification Engineer ? Full Time Position (San Francisco Bay Area)

DESCRIPTION: Work closely with marketing to develop product requirements. Work closely with other senior technical staff to identify the key technical challenges to meeting said requirements, and develop system architectures for IVD products. Improve on the process for system and sub-system verification, including test automation and traceability to requirements, specifications and risk. Partake in verification and validation testing as needed. These responsibilities also apply to integration testing. Perform system level modeling to determine power consumption, throughput/speed, cost, etc., for complex IVD products. Perform risk analysis, compliant to relevant international standards, for products in development. Some lab work with blood based in vitro diagnostics. Support activities and processes in compliance with applicable international standards and FDA guidelines....

Mechancial Designer/ Designer/ Drafter

GURU Designer / Drafter - Medical Device+ * CONFIDENTIAL - 3 rd PARTY RECRUITER My client is looking for a GURU Product Development Designer/ Drafter (4-15 years exp/ Associates Degree or Tech Degree) with Mechanical CAD Design or ME Technology. *Background in ME/CAD/ENG Tech, SolidWorks, ProE, Exp. Designing Mechanical Parts, Prototype Assembly, Small Components / Tolerances Design, Medical Devices+ This is a strong player in the Medical Device industry, looking to bring their new products to market through added manufacturing and increased product lines. They are looking for a strong mechanical aptitude as well as a commanding technical knowledge. This position will be requiring ?concept to manufacturing;? demanding innovative problem solving ability. They require a minimum 4 years experience in design of intricate, complex component devices. The candidate will be need hands on? ability and a MASTERY in SolidWorks or ProE as it relates to product designs. The company will consider candidates from any industry but prefers a top tier company and solid work history. (i.e. Boeing 5 years or Toyota 6 years). They are looking for OT ready applicants; provided their continuous expansion and opportunity to move up. Salary is among Industry Elite; along with a TIER 1 benefits package/ Relocation Assistance Other Highly Desired Applicants: Senior Product Development Engineers with Medical Device Experience Manufacturing Engineers & Senior Manufacturing Engineers Process Engineers & Senior Process Engineers Any Manufacturing, Mechanical and Biomedical engineering candidates with desired skills *Candidates must be out of a TOP Engineering school with near perfect marks - Advanced Degree Preferred Preferred Skills: CAD: SolidWorks, PROE FEA: ANSYS, GD&T Manufacturing: SEMA, LEAN, SPC, Process Flow Strategies (Kanban, Just in Time, Cell Manufacturing, Demand Flow), Blueprints and Specifications, Designing Equipment, Designing Tooling and Fixtures, High Volume Automations - High Speed Assembly, Products to GMP Production, Designing Pilot Scale and High Speed Manufacturing Equipment in State-of-the-Art clean rooms Quality: ISO Standards, Knowledge of FDA Regulations, cGMP for Medical Devices, R&R Highlighted from successful hires: ? ?Streamlined an innovative manufacturing overhaul through a new rotational design cutting manufacturing time by 30%? ? ?Cut cost of manufacturing by 22% for small tolerance spinal implant device? ? ? Manufacturing process of cardiac stent from 6 to 4 steps while increasing quality benchmarks? ? ?Part of the design team responsible for several profitable patents and the leading product driving company revenues? ? ?Lead designer that won the prestigious MDEA (Med Design Excellence Award) for reverse engineering competing drug delivery product and bringing to market at a cheaper cost? Thank You, Robert Bennett CEO, Director of Client Acquisitions Asset Personnel Solutions Submit Resumes Attention: Robert Bennett Resumes@Asset-personnel.com...

Project Engineer, JR

Responsibilities: -Participate in multifunctional teams, led by a Project Manager and be responsible for defined project deliverables -Manage -Engineering Change Notices for new products from creation to final approval -Operate quality systems to produce documentation such as process validations, equipment qualifications, dynamic control plans, inspection plans and standard operating procedures -Operate?New Product Development Process? [NPDP], to build robust processes through involvement in ?Design for Manufacturability? and ?Lean Manufacturing? initiatives -Utilize Six Sigma process tools such as ?Define, Measure, Analyze, Improve, Control? (DMAIC), ?Failure Modes & Effects Analysis? (FMEA), ?Design of Experiments? (DOE), Gage Repeatability & Reproducibility? (Gage R&R) and ?Statistical Process Control? (SPC) as required -Provide input to Capital Equipment Requests (CERs) Project Engineers in New Product Innovation will also: -Program CNC, robotics and other manufacturing equipment to produce high quality, repeatable output in a cost effective manner -Develop fixturing, work holding and gaging solutions to optimize the manufacturing process -Work with suppliers to ensure they understand and comply with our Quality and NPDP system requirements, particularly for Supplier Innovation role...

Field Service Engineer (215260-017)

Responsible for maintaining the reputation of AngioDynamics hardware as reliable and high-functioning medical equipment by providing the technical support, complex troubleshooting, and general maintenance of customer and company-owned hardware either in the home office or on-location with a focus on customer relationship building through prompt and efficient service. Position Responsibility: Perform hands-on assessment of hardware received for repair; implement diagnostic process and perform applicable repairs. Perform hardware installations and repairs at customer sites as needed with traveling flexibility. Ensure customer hardware is upgraded as needed; perform upgrades to hardware/software at customer locations. Collaborate with R&D in the development of technical documentation such as test methods, training updates, and service reference material. Submit ECOs as required for the amendment of test methods, training materials, service reference material, and other applicable SOPs. Make strategic recommendations to supervisor related to hardware service initiatives based upon field experiences and observations. Develop strong working relationships with biomedical departments, physicians, other hospital staff, office personnel, and outside sales personnel. Act as first point of contact for technical queries, providing troubleshooting and support by phone in case of equipment failure including out of hours ?on call" support. Follow all relevant SOPs and Service database procedures, utilizing the systems to their fullest potential and proactively suggesting and developing improvements to processes. Maintain a clean and safe working environment ensuring efficient and effective use of space in compliance with all regulatory standards. Actively participate in project teams, representing the hardware service department in a professional and cooperative interdepartmental atmosphere. The above is not intended to be an inclusive list of responsibilities. Other activities may be assigned as required by management....

Test Systems Engineer

Job Classification: Full-Time Regular Connect confidentially with MRIGlobalMedDevice at: Our client is a well-funded, early stage global med device company who is expanding their team. This company is on the threshold of something very big - this is a rare ground floor opportunity you won?t see often - huge market for their device. Wear a lot of hats in an environment of high motivation & initiative, focused on collaboration, teamwork , communication - work with people who are very excited to be there. Company offers every employee stock options so everyone has a vested interest in their overall success. Excellent compensation! Essential job responsibilities include, but are not limited to: Create equipment and software specifications for testing apparatus from product specifications and performance requirements Design analog and digital electronic circuits and mechanical hardware for automated test systems. Program test systems to meet the intended requirement by designing and developing software requirements and testing applications for automated testing equipment to be used for integrating and testing of electromechanical medical devices....

Sr. Engineer

Job Classification: Full-Time Regular Connect confidentially with MRIGlobalMedDevice at: This company less than ten years old and is growing rapidl!! Their fully-engaged, high-presence engineering group serves as the main engine for profit growth. There is also an established career ladder for engineers and the company believes in developing the careers of their employees to their fullest potential. This position is based in the Southwest region of the U.S. Relocation assistance is available to the right candidate. The position offers high visibility and career advancement opportunities....

Manager, Visual Inspection Engineer

Sanofi Pasteur, the vaccines division of Sanofi, is a global company that provides more than one billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Every day, the company invests more than one million Euros in research and development. Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients? needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Manager, Visual Inspection Engineer SME in Visual Inspection for the Swiftwater Site. Provides technical support and/or leadership to all Visual Inspection related subjects for site: Adjustment/tuning automated inspection machines Qualification of automated inspection machine recipesSupport the identification of critical process parameters and acceptance criteria for development and validation Training on the application of automated inspection machine configurations to optimize detection of defects in final containers, especially containers having particulates.Technical trouble-shooting and deviation investigation related to Visual Inspection Automated inspection machine equipment specifications, new vendor/equipment selection, and startup of new equipment SME for health authority inspectionsStays up to date on latest technical and regulatory trends in the biomedical imaging science, optical engineering and visual inspection arena...

Mechanical Project Co-op

DJO Global is a leading global developer, manufacturer and distributor of high-quality medical devices and services that provide solutions for musculoskeletal health, vascular health and pain management. We are currently seeking a Mechanical Project Co-op starting in the Fall of 2014 for the DJO Surgical Division located in Austin, TX. PLEASE NOTE: as this is a Co-op program, the student would need to commit to working a total of 3 Co-op periods of 40 hours each. Under this plan, students are required to complete a minimum of three alternating work terms. JOB DESCRIPTION The Mechanical Project Co-Op will assist the New Product Development Sr. Engineer and team on engineering and new product development projects for knees, hips and/or shoulders....

Software Test Engineer

for Medtronic, Inc. at its facilities located in Northridge, CA. Duties: Develop and execute software test plans in order to identify software problems in medical devices and their causes. Requires a Master's degree in Electrical Engineering, Biomedical Engineering, Computer Science, or related and one (1) year of post-bachelors progressive experience in all of the following: Software testing in the medical device industry; Software development life cycle; Mac and Window OS testing; Software verification and validation testing of insulin pumps and blood glucose meters; Software testing in Web and PC based applications; Test plans and test cases preparation which meet or exceed FDA guidelines; Defect tracking process using Seapine Test Track; Requirement management using IBM Requisite Pro; and Performance testing, database testing, web security, load testing, and installation testing. Apply at www.medtronic.com/careers, Req. 93601. Must have legal authority to work in the US. Medtronic is an equal opportunity employer committed to cultural diversity in the workplace. All individuals are encouraged to apply. Los Angeles Times 2014-07-03 Source - Los Angeles Times...

Principal Process Engineer

Principal Process Engineer Job Category: Research & Development Instrumentation Laboratory (IL) is a multinational company, a world leader in the development of in-vitro diagnostic reagents and instrumentation. Since its founding in 1959, IL has led the rapidly evolving markets of clinical diagnostic systems for blood gas and electrolytes analysis, hemostasis, and clinical chemistry. IL?s renowned medical technology is used every day in hundreds of hospitals and laboratories around the globe. It is IL?s focus on its customers-and on the patients whose lives are touched by its products-that is guiding the company into the next century. Position Description: Develop and improve manufacturing methods, systems, and processes to produce a high quality product at optimal cost. Act under general supervision of Process Engineering Management on multiple assignments of complex nature and broad scope. ? Concurrent Engineering:Support new product development or existing product line extensions/modifications by ensuring new products or manufacturing processes are designed to facilitate ease of manufacturing and to produce quality, cost effective products with optimized yields. ?Documentation: Define and generate all required documentation in support of manufacturing products and processes. These include: Engineering protocols, FMECAs, reports, manufacturing instructions and procedures. Ensures compliance with cGMP's and internal protocols. Uses appropriate statistical support and Design of Experiments (DOE) when developing recommendations. ?Equipment and Fixturing:Determine specific requirements of manufacturing operation in order to specify equipment, fixturing, and process parameters. Collaborate on design with suppliers to fulfill equipment and fixturing requirements. ?Qualification and Validation: Develop plans to evaluate process repeatability and stability through equipment qualification and process validation. Applies six sigma methodology as appropriate. ?Continuous Improvement and Cost Analysis:Continually improve manufacturing methods/systems and process/ product improvements to optimize product performance and reduce manufacturing costs. Identify and evaluate opportunities for improvement and make specific recommendations for adoption. Perform cost analyses to reduce or optimize product costs. ?Leadership: Lead team in operations related programs including product iterations, cost reduction programs, process changes across product lines and manufacturing layout synergies. May lead work of lower level engineers and I or technicians and provide performance input to reviewing manager. Qualifications: ?B.S. in Engineering, M.S. preferred ?Broad knowledge and experience with electro-mechanical, biomedical, and chemical manufacturing processes ?Minimum of 7- 10 years in process development and sustaining role in R&D or manufacturing or equivalent Desired/Preferred Qualifications: ?Knowledgeable in lean manufacturing principles and six sigma methodology ?IVD and/or Medical device manufacturing or manufacturing in highly regulated environment ?Excellent oral and written communication skills, including presentation skills ?Excellent PC skills, Excel, Project, Visio, Minitab, etc. ?Project management experience ?Proficient at interfacing with suppliers, engineers, scientists, and/or contractors effectively communicating requirements resolving conflicts and achieving objectives ?Solid interpersonal skills and ability to work in a team environment ?Proficient in statistical and financial analysis ?Demonstrated experience in the transfer of new products into manufacturing ?CAD skills If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Apply Now Instrumentation Laboratory appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V *cb...

Human Factors Analyst - Entry level

Job Description The position will be with the Wyle Bioastronautics Contract supporting NASA's Habitability & Human Factors Branch at the Johnson Space Center. The job will entail the following activities: perform detailed data collection, assessment and analysis of International Space Station (ISS) post flight crew debrief data from a habitability and human factors perspective; develop and maintain data products from the Flight Crew Integration (FCI) ISS Crew Comments database; provide human factors inputs to space systems; and develop human factors processes and standards. Essential responsibilities include: --Attend and document ISS Post Mission debriefs taking detailed notes and developing transcripts for over 30 debriefs per ISS Expedition that comprise the content of the FCI ISS Crew Comments Database --Develop, maintain, and update Post Mission debrief data products generated from the FCI ISS Crew Comments Database --Support detail-oriented, fast paced development of requests for data (consisting of various established products) from the FCI ISS Crew Comments Database --Apply post flight debrief lessons learned to the design and human factors analysis of existing and future spaceflight hardware, habitats, vehicles and relevant requirements, standards and guidelines --Communicate (verbal and written) the FCI ISS Crew Comments Database content and capabilities to a variety of audiences Basic Qualifications Bachelor's Degree in Human Factors or in a Human Factors related discipline (for example: Industrial Engineering, Psychology, Biomedical Engineering). Experience with at least one of the following: Excel, SQL, Text Analysis, and/or SharePoint. Desired skills Experience in Human Factors. Experience in technical writing and/or subjective data collection, archival and analysis. Experience or interest in systems integration. Excellent written and oral communication skills. Ability to maintain detail-oriented precision in a fast-paced work environment. Willingness and ability to work well in a team. Excellent organizational, communication, and presentation skills. Lockheed Martin is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, or disability status. Job Location(s): Houston Texas...

Software Engineer I-II

Does your work make a difference? Ours does! Patients and their families count on the reliability of our innovative products every single day. Come be a part of it. Founded in 1958, Spacelabs developed the first vital signs monitoring for NASA astronauts culminating in Neil Armstrong wearing Spacelabs telemetry for the moon landing in 1969. We operate in three clinical sectors: patient monitoring and connectivity, anesthesia delivery and ventilation and diagnostic cardiology. Renowned for its open architecture interfacing, Spacelabs is able to connect to a host of hospital data management systems enabling easy flow and review of patient data. Our goal is to provide transformative solutions to aid and accelerate the clinician?s decision making process. Our Mission: To inspire the world to bring the best care experience to patients and families. One patient, one family, one smile at a time . A Software Engineer I/II is needed for development of algorithms and software for real-time embedded software systems for patient monitoring. Personal development skills in requirements definition, design, implementation, and a passion for producing innovative, high quality products are essential. Candidates must be familiar and comfortable in all phases of the development lifecycle. Responsibilities Accomplish assigned tasks with minimal supervision. Demonstrate good documentation discipline. Complete assigned tasks on-time and in accordance with the appropriate process. Creatively and proactively address problems and find algorithm improvements. Participate in technical reviews to ensure product quality. Find creative solutions to broadly defined problems or directives. Analysis of marketing requirements. Participate in and/or lead design efforts. Create and test quality software personally and as part of a team. Estimate time and effort on projects and tasks. Foster good communication inside and outside the development team. Lead technical reviews of project software deliverables. Demonstrate ownership and responsibility for assigned tasks....

Senior Product Development Engineer - Sports Medicine

Job Summary: Position will direct, coordinate, and exercise functional authority for planning, control, integration, and completion of development engineering tasks within area of assigned responsibility by performing the following duties personally or through cooperation with team members and supervisors from other departments. Essential Duties: Plans and implements engineering project tasks, activities and milestones to support projects and sustaining engineering within the product development organization. Develops and maintains schedules and budgets for the assigned engineering project tasks which are submitted for management review and approval. Provides reports on the status of project tasks and milestones to project managers. May train, develop, and evaluate Engineering Co-Op students, Interns, and Product Development Engineers. May also manage one or more co-ops. Aware of NPI process and Design Control requirements on an Individual basis. Stay compliant with healthcare compliance policies as related to communication and interaction with healthcare providers. Required to support or lead "Needs Assessment Documents" (NAD) as related to current compliance subcommittee SOPs. Exercises some decision-making authority, later verified by the Department Supervisor. Advises the Department Supervisor, or designee, of transactions and/or special concerns on a daily basis. Performs related duties as required. Job Specifications: Requires the ability to be a self-starter requiring minimal supervision to accomplish assigned tasks. Independently solves practical problems and deals with a variety of concrete variables in situations....

Aerospace & Operational Physiology (AOP) Curriculum Developer

Aerospace & Operational Physiology (AOP) CurriculumDeveloper Company Description: PQC is an established and national award-winning professional services firm with an impressive track record of public and private sector contracts. We are an agile, lean, and growing company; in the past year alone, our growth rate has been over 115%. Our designations ? 8(a), Small Business, Disadvantaged Business, HUBZone, and Woman-Owned Business ? are extras that alone do not measure our company?s success. Our firm provides support to the Department of Defense (DoD) along with federal, state, and local governments in the public sector, as well as to higher education and commercial organizations in the private sector. We achieved an excellent reputation with our clients by developing and supporting project management, training, medical support services, administration, information technology, and many other services. Our core philosophy is ?Customer first while focused on employee success." Our success is based on that commitment, combined with a strong management plan, a proven team, and a history of exceptional performance. Position Description: This position?s main function is to support USAFSAM/AP byproviding technical and administrative services inclusive of: ProgramManagement Assistance, Technical Writing, Advanced Distributed Learning (ADL)support, and end-user information technology support. The applicant will needto have subject matter specific knowledge about the development of curriculumthat conforms to CFETP standards. They will also need to assist coursedirectors with Instructional Systems Development (ISD) and courseadministration including: analysis, designing, building, implementation, andrecommendation of existing and new course programs and materials. This position requires the abilityto provide educational expertise in ADL as well as demonstrate a proficiency inwriting on topics related to AOP. It is necessary for the applicant to be ableto demonstrate a strong ability to write on specifically on topics thatinclude: study guides, instructor guides, objectives, test questions, and ETCAcourse descriptions. All applicants interested in thisposition will need to participate in the 711 HPW sustained OPSEC awarenesstraining or include OPSEC training as part of their on-going security program.Finally, the contractorshall provide Information Security and Force Protection training as defined byAFI 31-401 and AFI 10-245....

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