Biomedical Engineering Career Careers in the United States

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Biomedical Technician (BMET)

Provide and demonstrate technical support for general patient care medical equipment and conduct the electrical safety inspections for the institution. This position conducts, provides records and maintains a database of scheduled preventive maintenance, unscheduled corrective maintenance, and safety testing in accordance with manufacturer, regulatory, institutional and department guidelines. Services will be provided as quickly as possible, with quality results at a competitive cost, supporting the institutional and divisional goals. Job assignment may require utilization of a car to get to and from various site locations and mileage will be reimbursed in accordance to institutional policy and procedures. Other: Effective operation of computer hardware and software to include Excel, Word, Windows 2003 and above. Must recognize and accept the need to always error on the side of a patient or operator?s safety, particularly when conflicting information or situations are present. Network experience as a BMET is highly desired. Company Profile MSS Services, Inc. is a SBA Certified 8(a) Small Disadvantaged Business consisting of highly skilled professionals who specialize in the management, administration, engineering, construction management, operation and maintenance of client facilities. We deploy the talents of our staff either individually or in a team format at the client facility in support of a specific need or range of needs as they are defined by the client's scope of work. Some examples include deployment of supplemental professional talent (i.e. Project Managers, Construction Managers, Engineers, Architects, Biomedical Engineers and Technicians, Project Controls Specialists, Contracts Specialist) to provide day-to-day care and oversight of building systems and to achieve the specified scope of work activities. http://www.mssserv.com/...

Quality Engineer - BioMedical - Direct Hire

This is position is Direct Hire. We will consider BiomedicalEngineering Degree - entry level to 5 years medical device quality engineer experience. Here is a great opportunity to gain exposure and insightto a very successful, well known, and growing Engineering team. We are lookingfor Medical Device Quality Engineers to learn our process and procedures andhelp make our products better. Our QEs work with industry changing products. Communication is critical! This position will work dailywith fellow engineers and our assembly line personnel to ensure NCR?s areinvestigated, root cause is found, and corrective actions are identified; thenimplemented. We look for problem solvers who know how to get thingsdone. Responsibilities Participate and perform equipment process optimizationand validations. Participate and perform discrepant material disposition. Update existing inspection plans, test methods, andstandard operating procedures. Participate in sample size determination, statisticalanalysis, training, and root cause analysis. Participate in process failure modes and effectsanalysis. Participate in various manufacturing projects such asprocess development, cost reduction and quality improvement initiatives. Collect, review, analyze, and trend quality indicatorsfor monthly and quarterly reviews. Participate in problem solving teams using standardizedinvestigation processes/tools. Requirements 0 - 5 years related experience in Medical DevicesIndustry (preferred, not required) A bachelor?s degree in Biomedical engineering field witha GPA of 3.0 or higher. Knowledge of Statistical Process Controls. Basic understanding of engineering and mathematicsprinciples. Understand interpretation of drawings, specifications,blueprints, and etc. Able to use inspection and measuring instruments such aslight microscopes, calipers, micrometers, tensile strength tester (e.g. Instronor Chatallion). Highly motivated, detail-oriented, eager to learn. Ability to use MS Office Tools such as Word, Excel, andProject. Strong analytical, problem solving and teamwork skillsare required. Able to follow instructions in all formats: written,verbal, and electronic. This position is on-site in Draper, UT Fulltime Monday ? Friday 8-5 Relocation is not offered and will not be considered. For immediate consideration do not reply to this ad. Send your resume to: with ?Quality Engineer" in the subject line...

Biomedical Engineer-Medical Equipment Repair

* Growth Opportunity For Experienced Biomedical Personnel* IMMEDIATE OPENINGS LOCAL BIOMEDICAL EQUIPMENT SERVICE COMPANY SEEKS PM AND SERVICE PERSONNEL TO MAINTAIN AND REPAIR MEDICAL EQUIPMENT IN HOSPITALS, NURSING HOMES, CLINICS AND OTHER HEALTHCARE FACILITIES MUST HAVE A BACKGROUND IN BIOMEDICAL EQUIPMENT REPAIR, TESTING AND PREVENTIVE MAINTENANCE. BIOMEDICAL EQUIPMENT REPAIR TECHNICIANS (SUPERVISORY POTENTIAL) We Accept Applicants Holding H1B Visas. Experienced Biomedical Technicians: should have medical equipment background. Will consider military or technical school graduate with a degree in electronics and related experience. Biomedical Field Service Technicians needed to perform inspections, preventive maintenance and repair medical equipment for health care facilities in the Greater New York Metropolitan area. We are a growing, Independent Service Organization (ISO) specializing in Nursing Homes, Physicians Offices, and DME dealers. Applicants should have a career (long term) objective to grow with the company. A BMET certification is a plus. Requirements Should be customer oriented Have experience servicing a broad variety of medical equipment `including general biomedical, enteral pumps, diagnostic and physical therapy equipment, etc. An Associates or Bachelors degree in biomedical engineering, clinical engineering or electronics (or military training) or related work experience. Note: Training will be provided on equipment with which applicant is not experienced....

Field Service - Biomedical Electronics

This position offers full benefits, job stability, a good work/life balance, and a company car. Overnight travel is infrequent (maybe 1 night per week at the most, never on weekends). Most travel will be day trips. Candidates must live within the general Dallas - Ft. Worth region. If you are qualified for the position and interested in pursuing it, please answer the questions posed at the end of the description and send me your Word formatted resume. Responsibilities: ? Performs preventive and corrective maintenance as directed and required. ? Performs the administrative duties associated with the job, including expense reports, time cards, parts requisitions, installation reports, service reports, and other reporting duties from time to time assigned. Assures that all paperwork is completed neatly, accurately and submitted promptly. ? Responsible for the maintenance of assigned tools, test equipment and tech spares. ? Performs on-call standby duty and travel as required. Must be prepared to work occasional overtime and odd hours, when directed. ? Responsible for developing and maintaining good customer relations....

Biomedical Instrument Service Technician (Electronic Technician)

Biomedical Instrument Service Technician (Electronic Technician) Troubleshoot?Repair?Maintain! For you, it?s all in a day?s work, and that?s why we want you on our team. If you?re a skilled Electronic Technician, you won?t want to miss this opportunity! We are seeking a Service Technician to join our dynamic in-house instrument service team. Immucor is a company in the biomedical technology field with a history of innovating to improve transfusion medicine and transplantation diagnostics. We have two business units: Transfusion Diagnostics, which includes our traditional serology products; and Transplant and Molecular Diagnostics, which includes the BioArray Solutions and LIFECODES products. Biomedical Instrument Service Technician (Electronic Technician) Job Responsibilities As an Instrument Service Technician, you will perform multiple tasks associated with in-house calibration, repair, and maintenance of Immucor's non-capital equipment. You will be responsible for all in-house instrumentation for Neo, Galileo, Echo, and Rosys systems utilized in customer training, production, product investigation lab, and technical training. Additional responsibilities: Performing repairs and preventative maintenance on internal systems Preparing repairable parts inventory for modules and various service components for service replacement parts Maintaining accurate and organized records for all maintenance, RMA's, parts shipments, etc., as needed Ensuring deadlines are met for communication with department owners of equipment and turnaround of repaired equipment Providing assistance to Field Service Engineers over the phone Leading / participating in instrument repair training classes Attending Technical and Managerial meetings with internal departments, vendors, and customers...

Biomedical Engineers / Techs

Biomedical company looking for Quality Engineers, Electrical Engineers, Mechanical Engineers,and Test Technicians....

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 Technician III - Anchorage, AK

Business Segment Healthcare Americas About Us What do you envision for your future? At GE Healthcare, we strive to see life more clearly. Our "healthymagination" vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing healthcare costs, increasing access and improving quality and efficiency around the world. We are an $18 billion unit of General Electric Company (NYSE: GE), employing more than 52,000 people worldwide and serving healthcare professionals in more than 100 countries. We believe in our strategy - and we'd like you to be a part of it. As a global leader, GE can bring together the best in science, technology, business and people to help solve one of the world's toughest challenges and shape a new age of healthcare. Something remarkable happens when you bring together people who are committed to making a difference - they do! At work for a healthier world. Learn More About Careers at GE Learn More About GE Healthcare Role Summary/Purpose GE is an equal opportunity employer, offering a great work environment, challenging career opportunities, professional training and competitive compensation. In this role, the Biomedical Technician III will properly respond to service calls to evaluate, diagnose, perform repair and planned maintenance (PM) on complex customer?s biomedical equipment and drive customer satisfaction through Service Excellence and may as part of their position function as Site Leader. This position is located in Anchorage, AK. Essential Responsibilities With minimal supervision, evaluate progressively complex, customer biomedical equipment issues, implement appropriate repairs; as assigned, perform planned maintenance (PM), safety and environmental inspections and maintain effective customer relations. Follow appropriate GE policies, procedures, hospital protocol and complete necessary documentation. Maintain daily communications with customers, to ensure resolution and proper follow-up, leading to customer satisfaction. As instructed, implement GE / customer facility contract, supporting business goals and objectives. May assist more and less experienced technicians on basic and complex repairs /resolution respectively. Work as a member of local team to provide efficient service delivery to all accounts within assigned area. When trained, share on-call / pager responsibility. Document all repair actions and submit reports/summaries according to schedule. Ensure proper care of spares, tools and test equipment and ensure calibration. Maintain approved parts inventory. Manage vendor?s service delivery processes in compliance with GE policies, as instructed. Enhance and maintain technical knowledge of current standards, codes and procedures regarding safe and effective use of medical equipment through formal instruction. Meet Health and Human Services, Environment Health and Safety requirements and/or all other applicable regulatory requirements. Perform other related duties as assigned. Quality Specific Goals: Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position Complete all planned Quality & Compliance training within the defined deadlines Identify and report any and all customer quality or compliance concerns immediately to the Quality Organization. Ensure all work orders, vendor service reports, time and expense reports, PM activities, purchase orders and other duties are documented in an accurate and timely manner. Ensure all test equipment is tracked and 100% calibrated on time. Qualifications/Requirements Minimum of High School Diploma/GED required AND one of the following:1) Minimum of one-year military experience or other equivalent formal training in maintaining electronics, electromechanical or medical equipment2) Minimum of an Associate?s degree in Electronics or Mechanical Principles. A minimum of four years of experience performing troubleshooting and planned maintenance on basic biomedical equipment following current standards, code and procedures to ensure safe and effective operation of those devices. Proficiency in completing electronic documentation using PDA and computer skills. Previous experience developing and maintaining good customer relations. Willing to occasionally travel outside of assigned region. Desired Characteristics Certified Biomedical Electronics Technician (CBET) desired. Previous experience interpreting schematic diagrams and perform effective repair and planned maintenance on basic biomedical or electronic equipment. Previous experience in a hospital setting. Analytical and communication skills with the ability to communicate technical issues to the customer in an easy to understand manner. Experience interfacing with both internal team members and external customers as part of a solution based service process. Change agent and process-oriented. Leading & Relating to Others: Establishes good relationships with customers and staff. Builds wide and effective networks of contacts inside and outside the organization. Relates well to people at all levels. Manages conflict. Shares Expertise: Applies specialist and detailed technical expertise. Develops job knowledge and expertise through continual professional development. Shares expertise and knowledge with others. Uses technology to achieve work objectives. Demonstrates an understanding of different organizational departments and functions. Organizing & Executing: Focuses on customer needs and satisfaction. Sets high standards for quality and quantity. Monitors and maintains quality and productivity. Works in a systematic, methodical and orderly way. Consistently achieves project goals. Takes responsibility for actions, projects and people. Takes initiative, acts with confidence and works under own direction. Initiates and generates activity. Communicating: Speaks clearly and fluently. Expresses opinions, information and key points of an argument clearly. Makes presentations and undertakes public speaking with skill and confidence. Responds quickly to the needs of an audience and to their reactions and feedback. Projects credibility. Coping with Pressure: Works productively in a pressurized environment. Keeps emotions under control during difficult situations. Balances the demands of a work life and a personal life. Maintains a positive outlook at work. Handles criticism well and learns from it. Supporting & Cooperating: Demonstrates an interest in and understanding of others. Adapts to the team and builds team spirit. Listens, consults others and communicates proactively. Supports and cares for others. Upholds ethics and values. Appropriately follows instructions from others without unnecessarily challenging authority. Follows procedures and policies. Compiles with legal obligations and safety requirements of the role. Embracing Change & Demonstrating Enthusiasm: Adapts to changing circumstances. Accepts new ideas and change initiatives. Adapts interpersonal style to suit different people or situations. Works hard and puts in longer hours when it is necessary. Identifies development strategies needed to achieve career goals and meet new or changing demands of the job. Commercial Thinking: Keeps up to date with competitor information and market trends. Identifies business opportunities for the organization. Demonstrates financial awareness. GE is an equal opportunity employer, offering a great work environment, challenging career opportunities, professional training and competitive compensation....

Biomedical Equipment Technician (BMET) Corpus Christi, TX

Description: TEAM is building a pipeline of Biomedical Equipment Technician (BMET) that will perform specialized duties utilizing general knowledge/skills in the area of support and maintenance of medical equipment. Duties and Responsibilities: Perform a variety of routine tasks associated with the installation, service and calibration of a diverse range of therapeutic and diagnostic biomedical instrumentation. Assemble, repair and maintain mechanical, pneumatic, electrical and basic electronic devices according to specifications. Perform electrical safety tests on biomedical instrumentation using specialized test equipment. Assist in the support of a systematic preventive maintenance program of biomedical instrumentation. Document the introduction of new therapeutic and diagnostic equipment, corrective and preventive maintenance actions and special requests as required. Install, maintain, service, modify, troubleshoot and calibrate a variety of diagnostic, therapeutic and life support devices by interpreting engineering and vendor information, schematic diagrams and graphic illustrations. Diagnose and correct system and equipment malfunctions by making alterations, repairs or replacements to ensure that medical equipment and internal circuitry meet specified requirements; make necessary calculations for computing circuit elements necessary to adjust circuitry to specified requirements as instructed. Provide technical assistance and instruction to Healthcare personnel in the operation and maintenance of equipment, assist in providing recommendations regarding purchase of biomedical instrumentation. Meets departmental performance indicator standards on a consistent basis. Maintains a professional appearance and demeanor. Demonstrates initiative and concern for planning, time utilization, and cost containment. Maintains good personal relationships with fellow workers, nursing and medical staff. Maintains accurate and timely documentation. Maintains a clean and safe work place. Performs all duties related to this position as they are needed. Develops and implements a plan for professional growth Basic Qualifications: Associates Degree in Biomedical Equipment Technology or equivalent; or DoD trained Biomedical Equipment Technician (BMET), or Certified Biomedical Equipment Technician (CBET) or equivalent BMET I -3 plus years of Experience BMET II-8 plus years of Experience Knowledge in preventive maintenance, calibration, and repair procedures of medical equipment Knowledge in equipment maintenance procedures Knowledge of equipment inspection procedures and basic equipment training Experience specific to sterilizers, lab, anesthesia, and diagnostic imaging equipment Possess analytical and problem-solving skills Ability to communicate effectively, both verbally and in writing Facial hair required to be controlled or trimmed, including beards, mustaches, and sideburns Possess a working knowledge of computers, specifically the internet and Windows Operating System Experience with MS Office applications including Word, Excel, and Outlook Must meet physical and health requirements, including immunizations, per contract requirements. Must be open to Part-time causal employment on as needed basis until full- time work becomes available. Must be willing to work at multiple facilities within a 150 mile radius of Corpus Christi, TX and be open to work globally for periods of time raging from one week to three months. Must possess a valid Driver's License Must possess a clear driving record. Must possess Basic Life Support (BLS) Certified Preferred Qualifications: Associates Degree or DOD Trained BMET Certified Biomedical Equipment Technician (CBET) Certified Radiological Equipment Specialist (CRES) Certified Laboratory Equipment Specialist (CLES) Knowledge/skills in logistics Position in Corpus Christi, TX TEAM is an Equal Employment Opportunity Employer of protected Veterans and individuals with disabilities. Veterans, minority and female applicants are encouraged to apply....

Biomedical Engineer

Summary Seeking a BioMedical Engineer (BS) with laboratory systems testing experience to perform reliability growth testing on highly complex systems, in support of the reliability plan for new product development and assist in complex data analysis. Essential Duties and Responsibilities Include but not limited to the following: Run reliability test systems to accurately simulate customer usage and real life conditions in accordance with reliability protocols. Perform required system scheduled maintenance and calibration activities in accordance with reliability protocol and /or operator manual. Review QC data and perform analysis of results in accordance with reliability protocol and/or operator manual. Tabulates and graphs data as required to perform analysis. Troubleshoot the following system failures to establish or assist in establishing the root cause: Failures requiring service intervention. Failures that can be recovered by the system operator. Not-reported results. QC failures. Assay calibration failures. Enter FRACAS records (Failure Recording and Corrective Action System) in ?real-time? for all system failures and system not available time events. Prepare for and attend Reliability Analysis Team meetings and investigate FRACAS records when requested. Assist in lab housekeeping and maintaining inventory of supplies. Maintain system log sheets and maintenance logs in compliance with applicable protocols. Comply with all applicable quality system requirements and prepare for internal and external audits. Adhere to all applicable industry and government standards regarding safe handling of biohazardous materials and comply with all company safety policies. Use required Personal Protective Equipment at all times. Reports potentially unsafe conditions. Complete all compulsory job, HES, quality system and vision training. Read job related articles and literature circulated within the department. Assist in writing and reviewing reliability testing protocols and reports as required. Train new reliability technologists when required. Perform additional research and development study protocols and other duties as required by the reliability laboratory supervisor. CDI Corporation is an EEO/An Affirmative Action M/F/D/V Employer...

Biomedical Engineer- (Research & Development)

Kelly Engineering Resources has an immediate opening for a CONTRACT R&D ENGINEER! Looking for an opportunity as a R&D Engineer in warm, sunny Florida? Want to work for a leader in the medical device industry!? Research and Development Engineer APPLY NOW! Contract Length : 1 year Shift: 8:30a-4:30p Location: Lakeland, FL JOB SUMMARY: The Research and Development Engineer designs, develops, and improves new processes for medical devices and directs the testing and evaluation of medical devices. ESSENTIAL DUTIES AND RESPONSIBILITIES: ? Perform Process/Product developments and validation. ? Ability to effectively interact within a team environment and with other departments such as Quality, Operations, Regulatory Affairs, Mfg. Engineering, Customer Service, Marketing, Sales, as well as external customers and suppliers. ? Ability to generate detailed project plans, multitask, and fast tracking of project tasks. ? Discusses progress and interim findings at periodic design review meetings. ? Continues with project in original concept or modifies direction based on commentary and decisions of design review committee. ? Establishes test protocols specified by customer input, national and international standards, and regulatory requirements. ? Directs and facilitates the testing of new products to verify product reliability. ? Plans and directs new product development. ? Interaction with Regulatory Affairs with transfer of device transfer to production floor. ? Assist in the development of technical protocols and reports. Improve/support existing processes. Knowledge of FDA requirements associated with the development of medical devices including Design Control and the technical support required for regulatory submissions. QUALIFICATIONS: ? In-depth knowledge of medical terminology/concepts related to medical devices. ? Proficient in project management principles. ? Proficient in managing projects to effectively complete assignments and achieve desired outcomes. Excellent organizational skills and ability to plan/prioritize activities. ? Ability to work independently or with a team. ? Strong verbal and written communication skills; ability to present issues, plans and objectives. ? Ability to work in fast paced organization, meeting multiple deadlines and succeeding under pressure is a must. ? Motivated, resourceful, ambitious, enthusiastic and attentive to detail. EDUCATION AND/OR EXPERIENCE: ? Bachelor's degree in an engineering or science field. ? 2-3 years experience in Mechanical, Electrical, and/or Biomedical Engineering or completion of an internship program in the medical device industry. COMPUTER SKILLS: ? Proficient in Microsoft Word, Excel, Power Point, Outlook, Project, Internet. ? Exposure to JD Edwards. WORK ENVIRONMENT: ? Office. ? While performing the duties of this job, the employee is occasionally required to stand, walk, sit, use hands to finger, handle, or feel objects; reach with hands and arms; balance; stoop, kneel, or crouch; talk or hear. ? The employee must occasionally lift and/or move up to 25 pounds. ? The noise level in the work environment is usually moderate. ? Employees need to consult MSDS in their work area. Deling with chemicals ? Required to wear Personal Protective Equipment to protect against exposure to Blood borne Pathogens and chemicals. 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 provides employment to more than 560,000 employees annually. Revenue in 2012 was $5.5 billion. Visit kellyservices.com and download The Talent Project , a free iPad ® app by Kelly Services. 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 iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc. Connect with us on...

Development Engineer III 600203 (NCI) Job

Development Engineer III 600203 (NCI) (Job Number:600203) Description: PROGRAM DESCRIPTION The Vaccine Clinical Materials Program, Leidos Biomedical Research, Inc. supports the Vaccine Research Center in manufacturing materials for Phase I & Phase II clinical trials. JOB DESCRIPTION Reporting to the Director, Manufacturing, the Manufacturing Engineer works on bioprocessing scale-up, technology transfer and bioprocessing troubleshooting problems where analysis of situations and of data requires in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining solutions. May determine methods and procedures on new assignments and may provide guidance to other lower level personnel. Will work directly with government process development scientists in the performance of assigned duties and will be responsible for ongoing communications to working groups and project teams....

Production/Manufacturing Engineer (Mechanical / Biomedical)

R&D Engineer POSITION SUMMARY The purpose of this position is to assist in the R&D activities for the Astigmatism Platform. ESSENTIAL FUNCTIONS / RESPONSIBILITIES Product evaluation / test method development: ~25% of time Support production builds: ~25% of time Partner with cross functional groups to execute activities: ~25% of time Order, track & receive raw materials for evaluation: ~25% of time...

MANAGER CLINICAL ENGINEERING

The incumbent will lead the Clinical Engineering Department through a focus on patient safety, regulatory accreditation, budget, and overall vision of support structure for all clinical service lines. They will perform a wide variety of planning, integration and productivity focused work as a leader of personnel working with medical equipment. The supervisor is responsible for assigning, directing, and evaluating the work of personnel assigned both within chain of command and as a team member on projects. The range of supervisory responsibility includes development of performance standards and performance evaluations; recommendations for awards, advancements, and when appropriate, disciplinary actions; and identification of continuing training needs. The incumbent provides direction and training to other clinical engineering equipment support personnel, clinical staff and vendors on the life cycle management of medical technology. Coordinating the approval of proposals for funding by YNHH clinical services to acquire medical technology and interacting with staff at all levels for the continual improvement of patient care services. The manager is responsible for financial management of budget resources allocated to support, procure, and maintain medical equipment for patient care activities. They have the responsibility for the development and delivery of clinical education sessions to educate staff, students and others on the operation, hazards and healthcare necessity of the equipment. Oversight of work involving significant engineering concepts and applications as an investigator; serving as senior author in the preparation of regulatory documentation that is necessary for accreditation of the clinical services provided by YNHH. RESPONSIBILITIES Works with management and other key leaders to ensure high levels of patient, employee, and physician satisfaction, often being a leader at points of collaboration. Ability to organize work, set priorities, delegate tasks, and meets multiple deadlines across multiple work sites. Skill in translating management goals and objectives into well -coordinated and controlled biomedical work operations. Oversight of Clinical Engineering work schedules and supplies. Collaborates with management on budget forecasting, capital planning, and coordination of projects , providing thorough feedback on cost of technology from purchase to decommission. Works with administrators, associated IT personnel, vendors and others to ensure proper flow of information through the electronic health record, accreditation databases, financial systems and associated operational improvement initiatives. Coordinates the collection and analysis of data on the medical technology impacts to clinical quality, patient satisfaction, economic efficiency and costs of equipment maintenance. Delivers timely performance reviews to personnel of the Clinical Engineering staff. Conducts an equipment management program that meets current regulatory requirements. Assuring the provision of a continuing education program for clinical staff addressing the principles and application of medical instrumentation used in the delivery of healthcare. This requires skill to effectively communicate, both orally and in writing, with a wide variety of individuals, including technical and professional clinical staff, to communicate technical information. Managing a recall and safety alert program for medical devices, including medical device incident investigations to assure compliance with patient safety goals, SMDA, and regulatory oversight. Expert knowledge of, and the ability to interpret and apply, complex codes, regulations, guidelines, and standards associated with the biomedical engineering field. Actively coordinates with the Director of Yale New Haven Health System to evaluate other programs in the health system. Conducts capital asset and infrastructure planning for medical equipment spanning initial concept, installation, and effective implementation of complex medical equipment. Participates at YNHHS level with capital asset planning. Analyzes organizational and operational problems and develops timely and economical solutions to meet facility, System or other needs. Skill in interpersonal relationships including conflict resolution. Will function as Site Leader and is responsible for customer relationship at assigned site (s). Assure service quality via frequent customer contact and formal quality reviews. Represent hospital in regulatory agency inspections and may sit on hospital safety and equipment selection committee. If assigned, track and analyze financial performance with DOS and SPC. May recommend equipment, parts and supplies. Implement procedures to provide quality, cost effective service. Responsible for prompt and accurate filing of expense, time and service reports, accounts payable and billing....

Manufacturing Engineering Manager

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 Mfg 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....

Phone Support Engineer

Description JOB SUMMARY: Provide customer support service on the operation, installation and repair of diagnostic instrumentation produced and sold by BD Diagnostic Systems (BDDS). Service includes telephone technical support, on-site visits and customer training as well as training of other service personnel and repairs performed on instrumentation located at BDDS facilities. Engineers will be expected to be committed to GMP, ISO, and Quality Standards. DUTIES AND RESPONSIBILITIES: Respond to customer telephone inquiries by providing diagnostic and other assistance on specific products supported and serviced by BD. Provide follow-up service by calling customers who have recently had service interactions. Provide service at customer sites and BD facilities when required. Assist with customer training. Be a participating member, representing the Service Engineering group, in project teams. Complete service documentation as required. Display maturity and judgment in time management and expense control. Report quality control and other technical problems in detail. Interface and work closely with advanced support specialists as required. Train other service engineers and biomedical technicians on theory of operation, repair, calibration and testing of specific BD products, instrumentation and software....

Field Service Engineer

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....

Regulatory Affairs Associate

Our client, a leading orthopedic company in Warsaw, IN is looking for a Regulatory Affairs Associate for a 1 year contract. Degree in Mechanical or Biomedical Engineering required but no Regulatory Affairs experience required, preferred. Job Summary Responsible for assisting the team with regulatory filings as necessary to market products. This is an entry level position, providing training towards full competency in Regulatory Affairs (RA). This position requires an understanding of products and their use as well as an understanding of the regulatory admissions process May perform some or all of the following functions, depending upon their specific assigned focus: Duties and Responsibilities ? Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions ? Assists in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions ? May provide regulatory direction to development project teams as a core team member; develops regulatory strategy for new products ? Reviews proposed labeling for compliance with applicable US and international regulations ? Writes package inserts ? Reviews and evaluates promotion and advertising material for compliance with applicable regulations ? Reviews proposed product changes for impact on regulatory status of the product Expected Areas of Competence ? Demonstrated strong writing and communication skills ? Strong attention to detail, ability to multi-task ? Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products ? Ability to function well as a member of the team and build relationships between RA and other areas of the organization ? Knowledge of FDA regulations (including labeling regulations) and regulations outside the US preferred ? Basic computer skills, including Microsoft Office Suite...

Verification & Validation Engineer

*****Software Test Engineer (Software Verification & Validation)***** Software tester needed to create and execute verification and validation test plans for Clinical Chemistry and Immunoassay blood analyzers as connected through a track-like design. - Understand complex software and hardware system designs and create test plans and test cases which are traceable to requirements. - Perform testing of Clinical Analyzer software through both hands ? on manual testing and through automated test tools. ? Test graphical user interfaces, complex sample sequencing and low level software communication protocols. ? Troubleshoot issues discovered in testing to determine the functional and logical areas of defect origination. - Clearly document test case results in summary test reports. ? Apply statistical quality control methods in the course of testing. - Use Application Lifecycle Management toolsets to plan tests and record test artifacts. - Use defect tracking system to record clear description of system defects, including reproducing steps and log files. - Maintain required laboratory records for instruments under test. - Ability to operate the workstations and instrumentation the software is deployed on. ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES, PREFERRED EDUCATION, EXPERIENCE - Demonstrated debugging skills in a complex automated instrumentation environment, including hardware, software, and mechanical components. - Experience with Defect Tracking Systems and Application Lifecycle Management tools. ? Basic understanding of automated testing development and execution. ? Knowledgeable in Waterfall, Cyclic and Agile software development cycles. ? Strong PC skills including the use of on ? line Data Bases, Internet Explorer, Word, Excel, and PowerPoint. ? Preferred the candidate has an understanding of the primary uses of a Clinical Chemistry Analyzer System in order to develop verification test scripts, boundary and stress test scripts. - Preferred the candidate has knowledge of hospital lab organization. ? Demonstrated flexibility to work in an environment with defined deadlines. - Excellent written and verbal communication skills a must to effectively communicate technical and clinical information to a diverse team ? Excellent interpersonal and collaboration skills to enable participation in product design and evolution ? Strong attention to detail ? Self ? motivated, as well as being able to accomplish tasks in a team environment ? Desire to learn new technologies and methodologies a must ? Must be able to thrive in an ever ? changing environment, with the capacity to handle deadlines, change, as well as ambiguity ? Passionate about finding defects, as early in the development cycle as possible. PREFERRED KNOWLEDGE/SKILLS, EDUCATION and EXPERIENCE: ? BS degree in Computer Science, Biomedical Engineering or Medial Technology or applicable experience preferred. - Medical Technologists AAS Degree in Medical Laboratory Technology preferred. Working knowledge of HIS/LIS preferred. - Experience with working in an FDA regulated environment is preferred GENERAL REQUIREMENTS: JOB FAMILY RESPONSIBILITIES: Debugs complex software products through the use of systematic tests. Develops and executes complex software test plans. Analyzes and writes complex test plans and testing procedures. Completes and maintains documentation of test results to assist in debugging and modification of complex software. Performs analysis of test results to ensure functionality and recommends corrective action. Completes the logging, tracking, communication, and resolution of issues. EDUCATION: BS/BA in a related discipline and/or applicable experience, KNOWLEDGE and EXPERIENCE: Demonstrates and applies a broad knowledge of field of specialization through successful completion of moderately complex assignments. Successfully applies complex knowledge of fundamental concepts, practices, and procedures of particular area of specialization. Demonstrates knowledge of organization's business practices and issues. Typically 5 ? 8 years of successful experience in related field and successful demonstration of Key Responsibilities and Knowledge as presented above. Advanced degree MAY be substituted for experience, where applicable. DIRECTION OF OTHERS: Provides general guidance or trains support and/or professional staff. KEY WORKING RELATIONSHIPS: Must have excellent interpersonal skills and be comfortable interacting with staff across functions and R&D sites. If you have the above qualification and are available to look into this opportunity please send me you updated resume along with your contact# and I will call you back to discuss further...

Design Engineer

Position Description: Looking for quality-oriented professionals who can help with creation of equipment specifications, fixture drawings and perform test method and/or inspection method validations for cardiac leads and device testing. Basic understanding of mechanical and electrical concepts required; some experience with Gage R&R and other statistical techniques is preferred. Ability to work independently, provide excellent attention to detail and communicate effectively with cross functional teams. Degree in mechanical, electrical or biomedical Engineering required....

MANAGER, CLINICAL ENGINEERING SERVICES

Responsible for planning and managing the Clinical Engineering Service Department. Working with clinical engineering staff; is responsible for the repair and ongoing operation of patient care equipment and related electronic systems. As requested; participates in purchasing decisions related to Medical equipment. The incumbent performs these tasks in a manner; which is consistent with the values and missions of BayCare Health Care System....

Informatics Engineer (Bioinformatics)

Job Classification: ContractInformatics EngineerAre you a guru in the management of the large scale data and web interface development with a specialty in bioinformatics and public biomedical databases? Do you thrive in an environment requiring multiple simultaneous projects?We are looking for an exceptional informatics engineer with expertise in information technology and bioinformatics to develop informatics infrastructure to support genomic studies and next generation sequencing (NGS). You must have skills in database and web user interface (UI) development. In this role you will be responsible for developing databases to manage genomics, NGS and medical research data. Also you must be able to develop web pages as the UI to access the database.Qualifications:? Minimum 3 years of relevant experience in the management of large scale biomedical data and development of the database and web interface.? Minimum 5 years proficiency with at least one script language (eg., Perl, PHP).? Experience working with microarray, qRT-PCR data and other biomedical data.Special Skills/Abilities: ? Experience in NGS data and administration of the Galaxy platform is a plus.? Experience with public biomedical databases.EducationBachelor?s or Master?s degree in computer science, computational biology, bioinformatics or relevant field.To succeed in the complex world of technology, you need exceptional connections - to the right experts, the right opportunities and the right answers. You'll find Modis right in the center of this ever-changing technological world - uncovering opportunities and connecting possibilities.As a global provider of IT staffing services, Modis connects the very best IT professionals to great opportunities at leading companies. And we do it every single day - for both temporary and permanent assignments and across virtually all industries. We use our insight, flexibility and expanded resources to anticipate the needs of leading tech companies and help them make exceptional connections with top tech talent.Please email resume to W...

Systems Engineer / Software Development Analyst

Are you a JAVA guru with a passion to innovate?! Or, a high energy developer or analyst who could join our quest to create the next health care game changer? Regenstrief Institute, Inc. is seeking top-notch talent to join our creative, intellectually stimulating, open work environment in supporting research and development efforts of leading edge medical informatics applications. A research affiliate of the Indiana University School of Medicine, for over 40 years, Regenstrief Institute has been a national leader in electronic health records, health care data integration, clinical decision support, medical informatics standards, improving health in older adults, health services and outcomes research, and more recently emerging in global and public health informatics and research implementation science. Our mission is to improve quality, efficiency and outcomes of healthcare locally, nationally and globally, and to develop the next generation of national and global leaders in biomedical informatics. These positions will be part of a dynamic and growing Center for Biomedical Informatics team of approximately 15 faculty and 80 research staff. The Institute also contains the Regenstrief Biomedical Informatics Fellowship Program and the World Health Organization's Collaborating Center for the Design, Application and Research of Medical Information Systems. Regenstrief Institute is the founding and main support site for OpenMRS which has been implemented in more than 50 countries on five continents. Please visit our website at www.regenstrief.org for detailed information regarding each of the following positions as well as the mission of our organization and research efforts to improve healthcare. Systems Engineer I Systems Engineer II Systems Engineer III Software Development Analyst The Regenstrief Institute is located on the IU Medical Center campus and will be moving (anticipated date: mid-2015) to a new facility in close proximity to its collaborative research partners: Eskenazi Health, the Roudebush VA Medical Center, IU Health hospitals and the Indiana Health Information Exchange. Qualified applicants should submit cover letter along with resume to . An Equal Employment Opportunity Employer...

VERIFICATION & VALIDATION ENGINEER ** Medical Diagnostic Devices

Chek Diagnostics, a medical diagnostic device manufacturer, is hiring a Sr. Manufacturing Engineer in Indianapolis, IN. Are you a results-oriented, hands-on leader? Do you enjoy testing and validating manufacturing products ? And, would you thrive in an entrepreneurial, energetic company that is experiencing consistent growth? COMPANY: At Chek Diagnostics, we take great pride in delivering industry-leading point-of-care and home diagnostics to the global health care market. Our focus is the development of diagnostic tests for chronic diseases such as heart disease, diabetes, and other related medical conditions. With 30% annual growth and strong profitability, we have committed to the ongoing development of innovative products for the early diagnosis and the ongoing management of these diseases; we take the business of supplying the highest quality, most technologically advanced tools possible very seriously. Founded in 1992, Chek Diagnostics is headquartered in Indianapolis, Indiana, USA. Our products are represented in more than 100 countries worldwide . OPPORTUNITY: As our Verification and Validation Engineer you will responsible for all verification activities and supports validation efforts for medical devices, chemistry strips, and supporting manufacturing processes . Reporting to the Director of Operations , you will be responsible for adherence to design controls as outlined by ISO and federal regulations in the development of new products and processes as well as improvements to existing products and processes. Remain alert to compliance situations with regulatory requirements of the Quality System documentation. Adopting a ?quality in everything we do" approach, remain alert to any potential compliance situations and reports such observations to supervisors and the Head of QA. KEY ACCOUNTABILITIES: Develop and execute medical device system verification and validation protocols and scripts. Includes both medical device and chemistry strips used in whole-blood analysis. Develop and execute equipment qualification protocols , such as IQ, OQ and PQ. Develop and execute software verification and validation protocols and scripts. Review supplier process and part verification documentation. Generate verification and validation report summaries and logging issues. Review and approve engineering change requests . Utilize issue tracking software....

Embedded SW Support Engineer

We are seeking a candidate foran Embedded SW Support Engineer position with one of our important clients.This position develops Embedded Software Applications for HSQa projects.Develops test/diagnostic software for integration of HSQa modules. SW/QAEngineer Software development responsibilities include reviewing software developmentlife cycle activities from software requirements; design and implementationthrough design verification. Must develop/review software test strategiesincluding regression analysis. Responsible for monitoring/reviewing test plansand test cases for software components. Work with R&D Teams to test andintegrate software using current software technologies. Responsible for faultisolation; troubleshooting; and root cause analysis activities during systemintegration and testing for systems in development and on-Market. Able to applythe latest software design and development tools and techniques as required. Software developmentresponsibilities include reviewing software development life cycle activitiesfrom software requirements; design and implementation through designverification. Must develop/review software test strategiesincluding regression analysis. Responsible for monitoring/reviewing testplans and test cases for software components. Work with R&D Teams to testand integrate software using current software technologies. Responsible for faultisolation; troubleshooting; and root cause analysis activities during systemintegration and testing for systems in development and on-Market. Able toapply the latest software design and development tools and techniques asrequired...

Systems Engineer (3925)

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 of Genomic Medicine in Farmington, CT is seeking a talented System Engineer to join our team. Key Responsibilities: Physical hardware installation, configuration, and maintenance of equipment to ensure availability of all servers, shared software, and enterprise applications. Create and maintain documentation as it relates to system configuration, mapping, processes, and service records. Propose and create system design models, specifications, diagrams, and charts to provide direction to system programmer and development teams for integrating servers, including database, e-mail, print and backup servers and their associated software into enterprise systems. Design and perform server and security audits, system backup procedures, and other recovery processes in accordance with the company?s disaster recovery and business continuity strategies. Act as project lead in the design and implementation of new server systems and applications, and gauge the effectiveness and efficiency of existing systems; develop and implement strategies for improving or further leveraging these systems. Conduct research on software and systems products to justify recommendations and to support purchasing efforts, and interact and negotiate with vendors, outsourcers, and contractors to secure system-related products and services....

Staff Engineer, Systems/Electrical

Overview: The Staff Engineer, Systems/Electrical supports the Bard Medical Division from our facility in Louisville, CO. Summary of Position with General Responsibilities: This position requires an individual to discover and drive new electromechanical and related product Concepts through the New Product Development (NPD) Process. This individual should have significant experience managing projects starting from concept and maturing through manufacturing and then commercialization. The position requires and individual to interact regularly with physicians and nurses in order to evaluate product performance and uncover unmet needs within the marketplace. This individual should have experience in launching multiple medical or pharmaceutical products through the NPD process. Essential Job Functions: Responsible for uncovering new product concepts and driving those product concepts into the New Product Development process Responsible for managing key project initiatives and successfully guiding them through the NPD process to a successful commercialization Help identify and evaluate new technologies for incorporation into BMD products Develops and prototypes new electromechanical product concepts and or features Identify unmet needs and industry trends through literature reviews, patent searchers, and customer interactions Help develop the business case for any new product concepts Assists in ensuring the QSR compliance of the design control process during product development. Generates intellectual property to support new product ideas and concepts...

Medical Device Product Engineer

. Adecco Engineering and Technical is currently recruiting for a direct-hire Medical Device Product Engineer located inAustin,Texas. You should have more than five years of Medical Device Development experience. You will have the opportunity to work on cutting edge products in a within a growing Medical Device company. In addition you will have the opportunity to present the product at different conferences. Responsibilities for the Medical Device Product Engineer include but are not limited to the following: Development of product specifications, drawings, test protocols and reports, and other design output Provide appropriate documentation to support regulatory submissions and technical files Research anatomical requirements Work with project team members and/or end users to establish product requirements Participate in risk management activities Support manufacturing process development Provide/review technical information to support the development of marketing tools such as brochures, technical bulletins, surgical techniques, etc Travel to industry trade shows, conventions, and off-site vendors to define and review functional related processes Candidates must meet the following requirements for consideration: Bachelor?s degree in Biomedical Engineering, Mechanical Engineering or related field. Five or more years in implantable medical device development Experience designing with ProEngineer or other design software. Must have strong interpersonal and organizational skills, possess multitasking capability, be computer literate, and be able to work independently. Understanding of GD&T If you are interested in the Medical Device Product Engineer job Click on Apply Now to be considered for this position or email me directly at J if you have any questions...

Sales Engineer- Medical Device- Northwest Territory

Sales Engineer- Medical Device- Northwest Territory I am working on a medical device business development position based out of N. CA for a leading medical device outsourcing corporation specializing in minimally invasive delivery & access devices. They offer a full spectrum of services to design, develop and deliver finished medical devices and OEM to the market. Company is ranked top 10 globally and involved with the most cutting edge technologies being developed in the medical device industry. Specifically, structural heart, advanced EP, AAA, and neurovascular technologies. We are looking for background combination of sales/business development and engineering, product development, design etc. Do you have an interest in exploring opportunities in this sector of the device arena? Send me your resume to: along with a good time that I can contact you. Allie Moser Executive Recruiter Career Search International...

Senior Systems Engineer ? Engineering ? Product Engineer ? Medical Device ? Product Development

Senior Systems Engineer ? Engineering ? Product Engineer ? Medical Device ? Product Development At Immucor, we are a company in the biomedical technology field that has a history of innovating to improve transfusion medicine and transplantation diagnostics. We have two business units now: Transfusion Diagnostics, which includes our traditional serology products; and Transplant and Molecular Diagnostics, which includes the BioArray Solutions and LIFECODES products. We partner with thousands of hospitals, laboratories and donor centers across the globe. We are seeking a Senior Systems Engineer with strong product development experience to join our Systems Engineering Department at our headquarters location. Job Responsibilities As a Senior Systems Engineer you will be a key problem solver and a potential core team leader to plan and lead cross-functional product development projects from concept to manufacturing. You will use expert technical skills, conceive, plan and lead R&D product development activities to achieve project goals. You will leverage understanding of advanced engineering principles, advanced engineering methods, data and judgment to influence the course of product development activities. Other responsibilities of the Engineering role include: Applying technical expertise in mechanisms, fluidics and electronics to lead efforts in test method development, implementation and validation for medical device/systems Leading efforts in creating and developing fixtures and building test stations for characterization, experimenting and testing novel medical device/systems Assessing design feasibility and testing product functionality and/or confirm product capabilities Designing experiments using DOE methodology and analyzing the test results using statistical tools Interpreting the results correctly and provide feedback effectively for design improvement Participating in the design of new products and design improvements to existing products Participating in the evaluation and assessment of competitive products, processes and/or new trends Engaging with the OEM?s to provide technical oversight and guidance on the evolution of the design...

Software Quality Engineer

KeystoneComputer Solutions has a twenty five year history of providing superior serviceand focused commitment to our clients, strategic partners, and the community.Trust in service delivery and adherence to best practices has made us apremiere collaborative solutions provider in the Twin Cities and awell-respected corporate citizen. KCS was initially formed to provide aframework for individual technology contractors to market their services to ITorganizations. Today KCS continues to successfully serve our candidates andclients by matching them up with the right opportunities. We are currently looking for a SoftwareQuality Engineer in the Northridge, CA area and would loveto hear from you if you meet the following criteria. **THIS IS A CONTRACT OPPORTUNITY? 5 months** Note: This positionis not for a testing role. POSITION DESCRIPTION: Ensure that software made / used by the client Minimed meets all applicable internal and external quality standards consistent with its intended use. Aid in defining product and software requirements as well as verification and validation activities. Ensure Software Quality Assurance-driven initiatives meet objectives in delivering highest quality products, with supporting tools and processes (e.g. product systems, product software, manufacturing software, R&D software tools, etc.). Act as a subject matter expert in systems engineering work products. Ensures that all system-level project / program work products (e.g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet the client?s quality, reliability, and compliance requirements. Provide internal consulting support to R&D, Regulatory, and business functions to help the company navigate a complex compliance landscape to meet its business objectives and exceed customer expectations. Interface with a broad range of cross-functional (e.g. R&D, Marketing, Quality Engineering, Production) and cross-facility (e.g. Puerto Rico, Minnesota, Ukraine) personnel. Lead / execute software validation projects. Lead software change control board (i.e. Software Change Review Group (SCRG). Lead and support software and system risk management activities. REQUIREDQUALIFICATIONS: Bachelor?s Degree in Engineering, Biomedical Engineering, Computer Science, or equivalent. Minimum of 5+ years related experience in systems engineering and quality assurance in some combination in a process-mature environment (e.g. FDA-regulated, FAA-regulated, DoD, CMMI ML 3+). Working knowledge of embedded systems and application software. Working knowledge of software development tools such as emulators, automated test tools, configuration management tools, defect management tools, and compilers. Working knowledge of various product-lifecycle methods (e.g. waterfall, spiral / iterative, scrum). Working knowledge of ISO 13485, ISO 14971, MDD, 21 CFR 820, IEC 62304, IEC 60601-1. Working knowledge of risk management, CAPA, and design controls. Strong working knowledge of various Software Development Life cycle (SDLC) models. Working experience with internationally certified quality systems, USFDA Quality System Regulation, and / or other mature regulatory or process models. Working knowledge of project management. Ability to effectively manage multiple system level projects / programs. Strong oral/ written communication skills and interpersonal skills....

Senior Product Engineer

ATI Powder Metals, an Allegheny Technologies Company, is a recognized world leader in the production of specialty alloys including titanium, nickel and specialty steel for the aerospace, biomedical, oil & gas, chemical processing and nuclear industries. We are seeking qualified candidates for the following position in Oakdale, PA. Senior Product Engineer This position is responsible for process/product development where processes and designs are developed and documented in order to meet or exceed customer expectations for a given product. Essential Job Functions include the following, other duties may be assigned: Develops and documents processes and designs used for the manufacture of the different alloy products. Manages projects covering technical feasibility, technical service, defining the manufacturing process, advising procurement, documenting data, writing reports. Develops and assures compliance with processing standards for both internal and external processing with focus on direct customer requirements including usable process path. Investigates and corrects rejection causes (i.e. problem solving) and/or non-random processing behavior (i.e. problem avoidance). Statistically analyzes processing data in order to insure product meets or exceeds customer requirements. Locates and develops working relationships with suppliers in order to perform work external to ATI Powder Metals. Assists sales with technical service on various accounts. Assists plant engineering on various capital projects for plant improvements. Lead risk assessment for product offering and customer specification updates. Qualified candidates will possess: Education: Bachelor's Degree in Engineering (preferably metallurgy, metallurgical engineering or material science) is required. Five or more years of product engineering/manufacturing experience is required. Strong communication skills (verbal, written, oral, listening & approachability). Excellent computer skills (specifically Microsoft Office products). Candidate must be a U.S. citizen or equivalent per ITAR requirements....

Electronic Engineer

Electronic Engineer needed for a six (6) month plus contract opportunity with Yoh's client located in Brea, CA. What You'll Be Doing: Defining and evaluating architectures in area of expertise for system modules and components of multi-functional systems - design circuit boards and sub-systems of limited to moderate scope using CAD/CAE tools Planning and conducting tests to verify theoretical analysis; performs empirical analysis, interpreting and evaluating experimental data to formulate conclusions; documents and communicates designs, specifications and project status; fabricates breadboards and prototypes; develops test plans, test specifications and design verification experiments; troubleshoots and analyzes complex electronic assemblies down to the individual components; and participates on multi-functional development teams Working simultaneous projects, small consecutive projects, and sometimes larger long-term projects Working with the new product development team to understand legacy products Working with the local manufacturing facility to troubleshoot current problems in manufacturing. Working with the Field Support Engineers to troubleshoot and analyze problems from the field What You Need to Bring to the Table: Bachelor´s Degree in Electrical Engineering. Two to four (2-4) years of experience in a related job area are required Candidate will have strong electrical engineering best practices and knowledge, with demonstrated ability to adhere to the rigorous lifecycle and documentation of requirements. Recent exposure to Cadence tools (Allegro/OrCAD PCB Designer) is required Experience with fabricating breadboards and prototypes; developing test plans, test specifications and design verification experiments; troubleshooting and analyzing complex electronic assemblies down to the individual components A high level of aptitude for Technical Writing and following engineering procedures is a must It is preferred the candidate has experience in an FDA environment but not required It is preferred the candidate has experience in disciplined problem solving using tools such as Fault Tree Analysis, the industry standard 8D process, or the A3 method It is preferred the candidate has firmware and software experience for embedded microprocessor-based systems Bonus Points! Otherwise Known As Preferred Qualifications: M.S. in Electrical Engineering is preferred. 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! What are you waiting for? Apply Now! Recruiter: Kathy Pavlick Phone Number: 610-787-0128 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. If you are an individual with a disability and you require an accommodation in the application process, please email . J2W: ENG...

Sales Engineer

Partial Job Description 1) Meet with peers/engineers in the medical device industry to sell client's services More questions? Want to know the Salary range? Keep reading. The best way to get more details is to click ?Apply?, upload your resume, and ENTER YOUR QUESTIONS in the ?Cover Letter? field. A recruiter will call you and answer all of your questions (if they feel you are a fit for the role). Your resume will be kept CONFIDENTIAL ? we respect your privacy. Our Recruiters are more likely to respond to your questions if they know you are *seriously* interested, and prefer to know a little bit about your background before calling. Tips: 1) Follow our CEO on Twitter for status-updates about your job application: http://www.twitter.com/sterlinghoffman 2) Add our CEO on Facebook: www.facebook.com/angel.mehta99 We will try to respond to your questions privately via Twitter or Facebook only. TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Healthcare, Life Sciences, Scientist, R&D, Clinical Research, Clinical Trial, Regulatory Affairs, Nutraceutical, Surgeon, MD, Hospital, Immunology, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility, Hospital, Research and Development, Medical Affairs, Drug Safety...

Principal R&D Engineer - Heart Valve Delivery System

George Konik Associates has partnered with a start-up medical device company located in the Minneapolis area, focused on the design and development of a new and innovative cardiac valve replacement system. The company recently completed the second part of a substantial Series A funding round with a strategic investor, and is now hiring for a Principal R&D Engineer to join their growing team. This position is an opportunity to join a well-funded company with experienced entrepreneurs at the earliest stage. This critical technical role will have the ability to directly impact one of the most significant device and market opportunities in cardiovascular medicine. Compensation includes a market competitive salary, comprehensive benefits including health insurance, and incentive options. Responsibilities Design/Development: Primary responsibility for design, technical direction, and project management of the delivery system including procedural sequence and requirements Determine design inputs including functional requirements of catheter components in the in vivo environment Structural design of delivery system deployment mechanisms and controls Develop acceptable size and delivery specifications for the implant component Support determination of the delivery profile/configuration of the implant component Responsible for developing intra-procedural imaging requirements Responsible for developing testing methods and parameters for tracking and implant delivery Responsible for development of pre-clinical test protocols and study execution Interface with other members of design and development team, specifically the implant component development members Project Management: Manage and develop work direction for technicians and other personnel directly working on the delivery system Track and communicate development status, including schedule, resource, and budget Manage vendor relationships specifically for design direction, schedule, and budget/cost Interface with physician and technical advisors Comply with applicable FDA and international regulatory laws/standards Complete documentation of all project information to conform to quality system and regulatory requirements....

Field Service Engineer - A Customer Service Expert!

Field Service Engineer - A Customer Service Expert! The Field Service Engineer II is field-based with front-line responsibility for installing, maintaining, servicing, troubleshooting, and repairing diagnostic imaging equipment at clinical sites, and supporting sales and business development efforts. Consensys Imaging Service is a leading national provider of diagnostic imaging service solutions, providing maintenance and field-based, on-site service and repair for diagnostic imaging equipment across multiple vendor platforms in the specific modalities of MRI, CT, Mammography, and Ultrasound. We leverage our proprietary technologies and capabilities to provide the highest quality equipment service and maintenance across multiple vendor platforms and modalities. Consensys is headquartered in the Chicago area and funded by Galen Partners Private Equity....

Software Engineer - Medical Devices

Software Engineer - Medical Devices Global leader in the development of life saving electronic medical devices seeks Software Engineers to provide technical and project leadership on software development projects. The Software Engineer will collaborate, influence and provide guidance to fast track software / firmware development. The Software Engineer will be an expert for systems, hardware and software engineering, working in a team environment with both internal and external development design partners....

Clinical Engineering Project Manager

Are you a self starting Clinical Engineer that gets great satisfaction from helping to advance the business through day to day projects and longer term process improvement initiatives? Sodexo Healthcare has an amazing opportunity for a Project Manager within a growth oriented Clinical Engineering Service Department within a large multi-sited university setting. Ideal candidate may be an entry level Clinical Engineer with a Bachelor?s or advanced degree, and 1-3 years clinical engineering technology experience. Prior experience helpful in reporting, relationship building, compliance, inter- departmental communications, working with inventory and databases, and biomedical or clinical engineering technology maintenance, repair and installation....

Mechanical Engineer

Job Classification: Contract Job Description: - Establish mechanical engineering specifications. Identify critical design factors and risks that impact customer needs and regulatory requirements. - Support root cause investigations and mechanical design improvements utilizing sound mechanical analysis - Create and maintain detailed component level drawings that include material specifications, material coatings, tolerancing and GD&T. Communicate project status, - Perform both empirical and theoretical analysis, interpret experimental data to formulate conclusions - Fabricate prototypes - Develop test plans and test specifications - Participate on cross-functional teams, working with other groups to resolve issues. - Exercises judgment within defined procedures and practices to determine appropriate action Work Environment: 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! Qualifications: Possess relevant baccalaureate college degree and five (5) years of relevant experience, or Masters degree and three (3) years of relevant experience - Experience with instrumentation design and integration including mechanical and electrical systems, fluid handling, thermal systems, pneumatic components, molding, and materials specification - Experience in mechanical and process design using CAD/CAE tools (SolidWorks preferred) - Demonstrated capability to troubleshoot, develop or improve mechanical and electromechanical systems using analytical and statistical methods. - Self starter with a demonstrated ability to focus efforts, overcome obstacles and complete key objectives - Continuous learner that seeks out challenges to improve skills - Innovative "out of the box" thinker that gets things done - Excellent written and verbal communication skills - Experience in developing products in a medical device or regulated environment preferred Performance Expectations: - Establish mechanical engineering specifications. - Identify critical design factors and risks that impact customer needs and regulatory requirements - Support root cause investigations and mechanical design improvements utilizing sound mechanical analysis - Create and maintain detailed component level drawings that include material specifications, material coatings, tolerancing and GD&T. - Communicate project status, - Perform both empirical and theoretical analysis, interpret experimental data to formulate conclusions - Fabricate prototypes - Develop test plans and test specifications - Participate on cross-functional teams, working with other groups to resolve issues Join Aerotek, one of the leading providers of engineering and engineering support professionals in North America. Due to our growth, we''re constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across a number of different industries. We know it''s more than just your day-to-day responsibilities that can make or break a job. It''s the support you get. That''s the reason Aerotek offers a variety of benefits including medical, dental, optical, 401k, and many more. Don''t put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law....

Project Manager (IRC5219)

Reporting to the Director of Program Management, this position is responsible for the successful planning, management and execution of global product development and design transfer of external products projects into Integra?s Neurosurgery Division in accordance with Corporate Quality/Regulatory and Product Development procedures. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Plan, manage and execute global product development projects in accordance with Integra?s Product Development process and procedures. Serve as the development project team leader motivating and driving cross-functional team performance toward achieving the common goal of completing the development project according to the defined objectives, on time and within budget. Manage virtual teams located at multiple sites. Employ excellent interpersonal, communication and negotiation skills with all levels of personnel and management to facilitate open communication among project team members. Coordinate communications among cross-functional team members, ensuring unified objectives and coordination of efforts Closely track personnel resource utilization and availability for each functional department. Plan appropriately to avoid resource bottlenecks. Effectively plan and manage financial resources and expenditures to stay within budgetary constraints. Guide project team members in the preparation of Design Control documentation as well as generate any project documentation assigned to Program Management. Guide project team members in the implementation and execution of the principles of Design for Six Sigma (DFSS) throughout the product development process. Develop, update and maintain detailed project plans and schedules using Microsoft Project. Effective lead and facilitate development project team meetings, including preparation of meeting minutes and documentation of key conclusions and action items. Prepare and effectively present project update presentations (PD Reviews and PD Gate Reviews) to Sr. Management. Effectively implement problem solving skills and techniques to identify potential issues, assess their impact, and develop and implement mitigation and resolution plans and activities. Provide periodic training for Integra staff on Integra?s Product Development procedures. Continue pursuit of project management excellence and engineering knowledge through seminars and other professional courses....

Senior Mechanical Design Engineer

We are looking for an individual that wants to be part of a high growth company and work with a team of talented professionals. This person will provide advanced technical leadership within the engineering group and have expert knowledge of the CAD system(s). Duties: Our Mechanical Design Engineers are responsible for designing and technically developing new products with a focus on new innovation products. Other responsibilities include: ? Research new design concepts, materials as well as new manufacturing techniques. ? Provide technical design engineering support for existing products and continuation engineering initiatives. ? Develop clinical requirements for new products (knowledge of ultrasound or radiation oncology clinical workflows a plus)....

Biodefense Laboratory Validation Engineer

Growing and well-respected biomedical (clinical, basic and applied) research firm has openings at USAMRIID . If you are passionate about research, and are looking for a firm that shares your passion, and provides competitive salaries with a strong benefits package, join the ClinicalRM team. We are currently seeking a Biodefense Laboratory Validation Engineer for the Frederick, Maryland area. RESPONSIBILITIES: Development, execution, data analysis and reporting of validation and qualification activities for laboratory instrumentation to meet GLP requirements. Employ a risk-based approach to qualification and validation activities, including a validation maintenance program. Under general supervision, review and provide authorization when justified for proposed changes to qualified/ validated systems. Identify the qualification/ validation requirements necessary to maintain the system?s validated status. Track and report to testing facility management on status of qualification/ validation activities and assists Chief, Regulated Studies on capital improvement initiatives. Provide validation metrics and business analyses for budget and resource planning to division management and above as required. MINIMUM QUALIFICATIONS: 1. B.S. in Chemical or Mechanical Engineering or similar scientific discipline 2. At least 3 years laboratory experience in the pharmaceutical industry 3. Preference will be given to candidates with relevant equipment qualification/validation experience in the pharmaceutical industry; MS combined with above experience preferred. 4. The contractor must be a US Citizen and must have a favorable National Agency Check with Law and Credit Coverage (NACLC) submitted prior to reporting for the first day of work. Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under ClinicalRM?s contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks. ClinicalRM is an Affirmative Action-Equal Opportunity Employer www.clinicalrm.com ?NorthCoast 99? Best Places to Work recipient...

Electrical Engineer

Our client is seeking an Electrical Engineer. This position will work within a project team, under the leadership of a principal engineer, systems engineer, and/or project manager. Individual will use experience and education to perform the types of engineering generally considered within the realm of electrical engineering. This engineer is expected to work and communicate well with other team members and leadership as assigned in order to meet the goals of the project, the department and the company...

Product Design Engineer

Breg provides premium, high-value sports medicine products and services that advance orthopedic patient care. From pioneering cold therapy products and innovative bracing to caring customer service and award-winning orthopedic practice solutions, Breg delivers a 360°customer experience unmatched in the industry. Founded in 1989, Breg offers cold therapy, knee, shoulder, spine, elbow/wrist, foot/ankle bracing and orthopedic practice solutions. The Company?s products are sold through more than 100 distributors in 36 countries. Breg is based in Carlsbad, CA. SUMMARY We currently have a full time opening for a Product Design Engineer at our Carlsbad, California headquarters. Responsible for concept development, product design, component and process design, testing, and validation of new products or processes. Among other duties will also be responsible for component prototype fabrication and testing, assisting with outside manufacturer selection, evaluation and communication. Provide manufacturing support when needed. Rely on limited experience and judgment to make recommendations and/or decisions within the scope of their essential job responsibilities under general supervision. ESSENTIAL DUTIES AND RESPONSIBILITIES ? Responsible for design, development, implementation, and analysis of systems, products, assemblies and components that meet specified requirements. ? Assists project leader in the definition, planning, design, testing, documentation, validation and manufacture of new products. ? Responsible for the on-time, on-quality, and on-budget delivery of project tasks. ? Product or component prototype fabrication, design evaluations, and testing. ? Recommends alterations to development and design to improve quality of products and/or procedures. ? Complies with all SOP and regulatory requirements pertaining to the development of medical device hardware. ? Develops and maintains product and/or process documentation. ? Supports the manufacture of existing products through needed design changes to improve quality/cost. ? Assists with outside manufacturer selection, evaluation and communication and provides support in the establishment and maintenance of suppliers. ? Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company?s policies and practices. ? Responsible for taking accountability to demonstrate the organization?s Cultural Beliefs and achieving desired results. Responsible for driving the Culture within the organization by using tools such as storytelling, focused feedback, and recognition. Performance is aligned with the Culture of Accountability - See It, Own It, Solve It, and Do It. All employees are expected to know and understand Breg?s Cultural Beliefs....

Clinical Engineering Manager I

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). 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....

Biomechanical Engineer

Rimkus Consulting Group, a global leader in the field of engineering consulting, is in need of technical professionals to promote our continued growth. We currently seek an experienced Biomechanical Engineer to support operations in our Las Vegas office. This is an exciting opportunity for anyone seeking to branch out and explore the world of forensic consulting. Essential Job Responsibilities 1. Analysis of human injury resulting from vehicular accidents, mechanical failures, falls, and falling objects, as well as industrial, construction, marine, and recreational accidents. 2. Responsibilities will include practicing vehicle accident reconstruction. 3. Review material (e.g., photographs, witness statements, depositions, police reports, medical and chiropractic records) to provide logical conclusions. 4. Identify and apply pertinent research literature and government regulations. 5. Conduct field evaluations and provide oral and written reports of findings. 6. Provide expert witness testimony via depositions or in a court of law, as needed. 7. Travel required primarily within the Western Region and occasionally outside the western United States as required to support the Company. 8. Develop client relationships by providing and maintaining the company?s high standard of customer service excellence and proactive client communications. 9. Work with local and national marketing managers to establish and grow relationships. 10. Multitask to meet the scheduling commitments of multiple clients and assignments....

Quality Systems Engineer

The Translational Genomics Research Institute (TGen) is a non?profit biomedical research institute based in Phoenix, Arizona, focused on research that can help patients with cancer, neurological disorders, diabetes and other debilitating conditions. Working with a worldwide network of collaborators in the scientific and medical communities, TGen researchers study the genetic components of both common and complex diseases. Through genomic analysis, we learn how DNA, genes and proteins ? the microscopic building block of life ? can affect human health. Our 35 lead investigators and nearly 300 support personnel at sites in Phoenix, Scottsdale and Flagstaff, Arizona, are dedicated to improving patient care and quality of life through precision medicine, best defined as the right therapy, for the right patient, at the right time. Brief Description : The Quality Systems Engineer's role is to develop and establish and document quality assurance standards and measures for the information technology services within the organization. Detailed Description : Develop and establish quality assurance measures and testing standards for new applications, systems, and/or enhancements to existing applications and systems throughout their development/product lifecycles. Also verify and revise quality assurance standards as needed. Conduct internal audits to measure and assure adherence to established QA standards for software development, application integration, and information system performance, and corresponding documentation. Create and execute test plans and scripts that will determine optimal application/system performance according to specifications. Ensure that testing activities allow applications/systems to meet business requirements and systems goals, fulfill end-user requirements, and identify existing or potential issues. Prepare and deliver reports, recommendations, or alternatives that address existing and potential trouble areas in IT systems and projects across the organization. Collaborate with software/systems personnel in application testing, such as system, unit, regression, load, and acceptance testing methods. Make recommendations for improvement of applications to programmers and software developers or systems engineers. Communicate test progress, test results, and other relevant information to project stakeholders and management. Assist in the development of change control processes, practices, and guidelines for new and existing technologies. Participate in developing, distributing, and coordinating in-depth end-user reviews for modified and new systems or applications....

Controls / Automation / Software Engineer

CONTROLS / AUTOMATION / SOFTWARE ENGINEER My client creates systems for high-performance applications in the Electronics, Photovoltaic, Biomedical, Aerospace, and Defense industries. This is a newly created position due to growth of the company and its focus is to engineer controls and software needed in their complex, automated systems. . Responsibilities Define the overall system control architecture, including associated process control hardware and software Develop specifications, select suppliers, platforms, and components, and write code Define and manage projects, directing internal and external resources in hardware and software development Collaborate with engineers, scientists and technicians to create innovative new products and applications, and refine and expand the performance of existing products Liaise with customer and third-party automation engineering and oversee system integration Perform hands-on prototype assembly and system testing, in-house and in the field...

Senior Medical Imaging Software Engineer

PrescientImaging (Hawthorne, CA) is looking for a talented SoftwareEngineer to join us to develop a novel medical imaging system. The SoftwareEngineer will be involved in, but not limited to, development of graphic userinterface software, image processing and analysis software and the design of auser medical imaging workflow....

Utiliites Verification Engineer

Description PSC Biotech is one of the world's largest compliance consulting firms specializing in compliance consulting in the life sciences industry. We are seeking three (3) Utilities Verification (Validation) Engineer resources to work with our client in Seattle, Washington. Responsibilities The Verification Engineer will be responsible for functioning as an individual contributor. The assignment duration spans the projects until the time of IOQ/PQ completion. The verification activities and deliverables are as follows: Verification of punch list completion post-System Installation Completion. Preparing, and facilitating the review and pre-execution approval of Qualification Protocols. Execution of Qualification Protocols. Preparing, and facilitating the review and approval of the Qualification Reports. Preparing, and facilitating the review and pre-execution approval of FAT Protocols. Execution of FAT Protocols at the equipment vendor sites. Preparing, and facilitating the review and approval of the FAT Reports. Preparing, and facilitating the review and pre-execution approval of Site Verification Protocols. Execution of Site Verification Protocols at the client site. Completing, and facilitating the review and approval of each Release For Use (RFU) form. Preparing, and facilitating the review and approval of the Site Verification Reports. Documenting and resolving deviations during Qualification, FAT and Site Verification. Post-execution updates (Qualification, FAT and Site Verification) to Traceability Matrices, and facilitating the review and approval of the post-execution matrices. Turnover Package document verification and control of turnover documents post-turnover from construction until turnover to the client. Preparing, and facilitating review and approval of FMEA Risk Assessments. Preparing, and facilitating the review and approval of Traceability Matrices. Preparing, and facilitating the review and pre-execution approval of Qualification Protocols. Execution of Qualification Protocols. Documenting and resolving deviations during Qualification. Preparing, and facilitating the review and approval of the Qualification Reports. Preparing, and facilitating the review and pre-execution approval of FAT Protocols. Preparing, and facilitating the review and approval of the FAT Reports. Preparing, and facilitating the review and pre-execution approval of Site Verification Protocols. Preparing, and facilitating the review and approval of the Site Verification Reports. Post-execution updates (Qualification, FAT and Site Verification) to Traceability Matrices, and facilitating the review and approval of the post-execution matrices. Transmit completed documents to the clients Document Control....

Product Engineer

Product Engineer Reports To: Director of Engineering General Responsibilities: The Product Engineer is responsible for new product development and support of existing products. This position takes cross functional inputs (Marketing, Product Integrity, and Supply Chain) and develops solutions to bring product ideas to realization. The Product Engineer will manage key projects with metrics for product performance, project cost, and the launch schedule. This position works closely with Product Integrity to validate new products and product changes. Periodic (about 10%) domestic and international travel is essential. Examples of Typical Activities: Lead cross-functional teams to develop and implement new products, cost reductions, and product improvements. Ensure regulatory compliance for the design and development of medical devices and children?s products. Communicate with domestic and foreign suppliers (e.g. China, Thailand, Mexico). Create and maintain product specifications, including 3D and 2D product CAD data. Create and maintain Bills of Materials. Plan and execute Engineering Changes....

Senior Imaging Quality Engineer

Rapiscan Systems is a leading manufacturer of security and inspection systems and markets its products world wide. Our products are used for the non intrusive inspection of people, baggage, vehicles and cargo in order to detect weapons, explosives, drugs, nuclear materials and devices as well as other types of contraband. The successful candidate will be a senior member of the Science Group investigating new detection techniques for explosives, nuclear materials, narcotics and other threats for homeland security. Candidate will assist in the development of imaging processing and analysis algorithm for air/sea cargo and baggage scanning....

Mechanical Design Engineer

Job Classification: Full-Time Regular Connect confidentially with MRIGlobalMedDevice at: Essential job responsibilities, but not limited to: Perform mechanical design, verification, and testing of new ophthalmic medical devices and systems. Use 3-D CAD Software tools to design and model both static and dynamic mechanical system. Create engineering documentation including component and assembly drawings. Introduce new or significantly enhanced manufacturing processes related to medical device product line and develop conceptual designs and layouts. Research and Analyze customer design proposals, specifications, manuals, and other data to evaluate the feasibility, cost and maintenance requirements of designs or applications....

Drug Delivery Principal Engineer

About the company: Fast-paced, highly innovative life sciences company working with cutting edge technology. This role sits within a start-up group in a global organization. Job description: Reporting into the Head of the Product Development group, this Technical Lead within Product Development will join a highly collaborative Engineering team focused on New Product Introduction within a biotech environment in the combination device group. This role will have at least 2 direct reports. Responsibilities include: * Lead a team of project engineers in concept and production of device development activity * Perform mechanical, fluid, vibration, thermal, and reliability analyses to support new and existing product designs. * Leads, plans, organizes and manages projects of significant scope. * Discover and develop improved assembly and testing technologies in support of device group. * Develop reliable manufacturing processes with associated fixtures and process control methods. * Debugging new designs and developing reliability improvements to existing and new design * Work with Quality Assurance and Research and Development to maintain an approved internal Quality System that meets the requirements of FDA QSR21 CFR 820 / ISO 13485. Who we are looking for: * Bachelors Degree in Mechanical, Biomedical or Plastics Engineering is required * Masters or PhD strongly preferred * 10-15 years of product development experienced focused within device development * Experience with drug delivery devices is required - pens, autoinjectors etc * Prior experience, knowledge developing medical devices in an FDA regulated environment. * Validation processes experience (IQ/OQ/PQ) in combination product device manufacturing environment * Strong background within regulatory compliance requirements of device design controls, risk management and combination products * Industry experience in Medical Device/Biotech/Pharma is a must have What's on offer: Competitive salary, excellent benefits and opportunity to thrive in a fast-paced high profile position...

Sr. Relay Technician (KS)

Sr. SUBSTAIN RELAY TECHNICIAN Vaco Engineering is a national consulting and placement firm providing professionals to our clients on a contract or career basis. We focus in Electrical, Mechanical, Chemical, and Industrial Engineers that are hired in all areas of products design, manufacturing, quality, process improvement, and compliance. Our clients are from a variety of industries including biomedical, defense, medical device, medical implants, custom chemical manufacturers, power/utilities, recycling plants, and consumer packaged goods. Our client is looking for the following: Senior Relay Technician - High Voltage - Substations - Engineer Sr. Relay Technician, Kansas - $40-$60 hour -Career Opportunity. (overtime eligible) 2 Openings- Qualified Candidates must have at least 7 years of field experience in testing and commissioning substation control equipment for high voltage electric utilities companies. Experience should include both maintenance of existing structures and new construction. The right candidate will have worked with DOBLE 6150 or similar program and have experience with micro-processor relays, SEL Slicers or Bassler Relays. Essential Job Responsibilities: Testing and maintenance of high voltage (13kv and above) substation power equipment including relays (electro-mechanical, solid state and microprocessor, and voltage regulating systems. Calibrating Relays and programming regulator controls Writing test plans Troubleshooting and repair of substation relay control systems Qualifications As a Senior Substation Relay Technician you must have the following: Minimum of 5 years commissioning substation control systems (electromechanical/microprocessor) including carrier systems, generator relay, line protection, transformer protection, feeder protection, bus protection, and breaker failure. SCADA/Fault Data/SER/Integration-Automation Equipment Experience with 3 phase DOBLE test set (6000 series) Experience interpreting wire diagrams...

Audio Visual Integration - Installation Engineer

Chicago, IL - The AVI - Installation Engineer will perform the installation of hardware and software associated with AVI Integration Systems. The incumbent will be responsible for product installation through careful project planning and installation throughout all phases of the project. He/She will be responsible for managing A/V Integration installations following the Olympus AVI Order Realization Process. The incumbent will interface with other project stakeholders such as architects, boom companies, project managers, sales, and customers. EOE M/F/D/V...

Quality Assurance Engineer

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 Quality Assurance Engineer in North Austin, Texas. We are located near 183/Burnet Road area. Utilizing a fundamental knowledge of engineering and problem-solving principles, this position is responsible for a variety of moderately complex activities regarding the designing, implementation, and maintenance of quality assurance protocols and methods to ensure external safety, quality and compliance with Company standards and government regulations. Duties may include but are not limited to: designing moderately complex methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, equipment and finished products; performing moderate analysis of reports and production data to identify trends; initiating, developing and recommending updates or changes to quality standards and procedures; assuring compliance to internal or external specification and standards (i.e. GLP, GMP, ISO, Six Sigma); reviewing trends in device failures associated with customer complaints and nonconforming materials; participating or leading in corrective and preventive action investigations; working on moderately complex special projects as assigned. 80% of time is spent in a resource capacity. 20% of responsibilities are in leadership activities....

Laboratory Assistant

Laboratory Assistant opportunity available for first shift contract assignment! Every day, Kelly Services connects scientific professionals with opportunities to advance their careers. A Laboratory Assistant contract assignment is available with a medical device healthcare company located in West Chester, PA. Work schedule will be Monday ? Friday, typically 8a ? 5p. Pay rate range is $13-$15/hour, which is based on experience. The duration of assignment is 8-9 months; however there is possibility of extension. Responsibilities of the Laboratory Assistant: ? Perform rudimentary and many times repetitive techniques in support of biomedical engineering endeavors. ? Conduct product disinfection, handle chemicals, maintain MSDS and associated documentation. ? May investigate testing abnormalities, gap assessment, and implement corrective/preventive action. ? Assist with specialized projects lead by others. ? Develop, maintain and follow appropriate SOPs. ? Actively communicate with cross functional team and suppliers. ? Perform statistical and trend analysis using Microsoft Excel or advanced statistical tools Requirements of the Quality Chemist: ? Associate or Bachelor degree in Engineering or Scientific discipline (Biology, Chemistry, Biochemistry, Biotechnology). ? Experience in regulated quality environment preferred, but not required. ? Knowledge and experience in material control, testing and disposition. ? Good communication, organization and computer skills are required. Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, please click the Apply Now button to submit your resume. If you have questions about the position, you may contact the recruiter at . We invite you to bookmark our Website and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com . 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 provides employment to more than 560,000 employees annually. Revenue in 2012 was $5.5 billion. Visit kellyservices.com and download The Talent Project , a free iPad ® app by Kelly Services. Our science specialty places professionals to a broad spectrum of industries, including biotechnology, chemical, clinical research, consumer products, biotechnology, consumer products, environmental, food sciences, pharmaceutical, and petrochemical fields. Want more information? Visit kellyservices.com/science iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc. Connect with us on...

Human Factors Engineering Intern

Sonalysts, Inc. is seeking a Human Factors Engineering (HFE) Intern who will provide Human Systems Integration (HSI) support for our Mid-Atlantic Group (MAG) customer base, primarily the Naval Surface Warfare Center- Dahlgren Division. Position is open for the summer, and is flexible based on individual?s institution schedule. This position will support a range of military acquisition programs, and, depending on program requirements, responsibilities may include the following: HSI requirements analysis. Development of HSI program documentation. Human-Computer Interface design. Usability testing and/or heuristic assessment of emerging systems. Human performance studies. Collaborative interaction with software and systems engineers. Cognitive Task Analysis (CTA) in support of system design. Research and Development (R&D) on a variety of Sonalysts? Human-Autonomy Interaction Laboratory (HAIL) projects. Founded in 1973 and headquartered in Waterford, Connecticut, Sonalysts is an EMPLOYEE-OWNED company known for its first-class technical capabilities precisely aligned with communication expertise, creativity and an understanding of the "business" of both government and commercial projects. From the beginning, Sonalysts sought to provide the best in professional services to its customers while creating an environment of accountability and partnership among its employees. This strategy has proven indispensable in Sonalysts' cultivation of a loyal clientele resulting in steady corporate growth for over 30 years. Today with approximately 400 highly skilled professionals in more than a dozen offices around the country, Sonalysts provides solutions to the wide variety of complex challenges facing the government, corporate and entertainment industries. Benefits include health, dental, life, and disability insurances; retirement plans; tuition reimbursement; and flexible working schedule. Visit our website at www.sonalysts.com for more information about our unique company and other exciting employment opportunities. EOE/M/F/D/V Drug Testing Employer...

Design Quality Engineer, Sr.

Stryker Sustainability Solutions is the leading provider of reprocessing and remanufacturing services for medical devices as well as comprehensive recycling and redistribution initiatives. Stryker was the first global Original Manufacturer (OM) to offer innovative, cost-effective programs, such as reprocessing and remanufacturing, to help meet the resource management demands of its hospital partners. Stryker's programs specifically target inefficient practices and reclaim and redirect consumable and financial resources in order to promote healthy and responsible hospitals. Stryker customers include most of the ?Honor Roll? hospitals recognized by U.S. News & World Report. The 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. - 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. - Analyzes, reviews, and approves standard methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment and recommends corrective action. - Analyzes, reviews, and approves standard manufacturing procedures and engineering systems for medical devices. - Analyzes, reviews, and approves equipment qualifications in preparation for design verification testing and/or process validation testing. - Analyzes, reviews, and approves test methods to ensure repeatability and reproducibility. - Analyzes, reviews, and approves standard process and product protocols. - Analyzes, reviews, and approves reports and recommends corrective action. - Provides sound statistical rationale for test sample size determinations. - Analyzes test data by using sound statistical techniques and communicating the results - Uses sound statistical rationale to analyze and interpret engineering test data collected during new medical device testing. - Verifies that new medical devices are technically sound and in compliance with FDA and other regulatory bodies. - Fundamental knowledge of applicable regulations and standards (e.g. QSR, ISO 13485) - Improves and/or supports existing processes. - Supports team initiatives - May interact with customers to solve 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. Education & Experience: - Bachelor's degree in an engineering or science field. - Minimum of 5 years experience in Mechanical, Electrical, Chemical, Material Science, and/or Biomedical Engineering. - R&D and/or NPD experience preferred. - Proficient in Microsoft Word, Excel, Power Point, Outlook, Project - Experience with statistical software packages such as Minitab or JMP is desired. Qualifications - Strong verbal & written communication skills. - Excellent organizational, problem solving, and analytical skills - Ability to manage priorities and workflow - Versatility, flexibility, and a willingness to work within constantly changing priorities - Ability to handle multiple projects and meet deadlines. - Good judgment with the ability to make timely and sound decisions. - Working knowledge of data collection, data analysis, and evaluation, and scientific method. - Ability to observe and note minute inconsistencies. - Ability to generate, follow, and explain detailed instructions and inspection procedures. - Ability to complete detailed documentation accurately. - Ability to analyze and resolve routine issues using independent judgment....

Packaging Engineer

Job Classification: Full-Time Regular Connect confidentially with MRIGlobalMedDevice at: Our client is a leading medical device developer and manufacturer located in the southeast portion of the United States. Their products have a global presence and their employees strive for continual excellence! The company offers great benefits, competitive salaries and will provide some relocation assistance to the southeast portion of the US if necessary! Essential job responsibilities include, but are not limited to: The packaging engineer shall support packaging and labeling related projects and activities for sterile and non-sterile product families. Develop packaging, documentation, labeling and processes for projects. Under limited supervision/guidance, compiles, analyzes, and reports operational test and research data to establish performance standards for newly designed or modified packaging, products, processes and materials....

Senior R&D Engineer

Senior R&D Engineer Austin, TX ArthroCare Corporation (Nasdaq:ARTC) - founded in 1993 is a highly innovative, multi-business medical device company that develops and manufactures surgical devices, instruments, and implants that strive to enhance surgical techniques as well as improve patient outcomes. Its devices improve many existing surgical procedures and enable new minimally invasive procedures. Many of ArthroCare's devices use its internationally patented Coblation(R) technology. This technology precisely dissolves target tissue and limits damage to surrounding healthy tissue. ArthroCare also develops surgical devices utilizing other patented technology including its OPUS(R) line of fixation products as well as re-usable surgical instruments. ArthroCare is leveraging these technologies in order to offer a comprehensive line of surgical devices to capitalize on a multi-billion dollar market opportunity across several surgical specialties, including its two core product areas consisting of Sports Medicine and Ear, Nose, and Throat as well as other areas such as spine, wound care, urology and gynecology. Our greatest achievements come from our greatest assets: ArthroCare's employees. We are continuously seeking new talent to join ArthroCare's winning ranks. People who thrive at ArthroCare are passionate about improving surgical procedures and patient outcomes, have a competitive spirit and winning attitude, and place a high value on teamwork and trust. We offer a competitive benefits package and excellent opportunity for career development. Summary: This position will lead project teams responsible for the design and development of sterile, single-use, medical devices for minimally invasive and open surgical procedures. Essential Duties and Responsibilities include but are not limited to: (Other duties may be assigned): Lead and conduct design, development, and market introduction for new electro-mechanical medical devices. Conceptualize innovative designs and resolve them into CAD models, assemblies, and drawings. Iteratively design, build and test functional breadboard and prototype models, to achieve proof of concept, and assurance of meeting clinical and user needs. Interact with physicians to identify user needs to improve product designs and procedural outcomes. Resolve problems using solutions that involve new techniques, technologies, or concepts. Work closely with supporting departments, to drive projects to completion within identified schedule. Adherence to, and implementation of, ArthroCare procedures and policies. Manage the working partnerships with multiple outside resources contracted for the concept/product development, prototype/pilot fabrication, and testing of devices. Support implementation of designs and processes to improve device cost, performance and/or reliability. Produce quality documentation associated with new product development. Supervisory Responsibilities: Project Management Manage complex development projects. Potential direct supervision of R&D Technician(s) and Engineer(s). Manage relationship with outside contractors and consultants....

Principal/Sr. Principal Engineer (LZ00097)

Fresenius Kabi (www.fresenius-kabi.com) is a leading global health care company that focuses on medicines and medical devices used to care for critically and chronically ill patients. Our products include intravenous specialty and generic medicines, infusion therapies, blood-transfusion technologies and clinical nutrition. Our roots go back more than 100 years to the founding of our parent company, Fresenius SE, in Bad Homburg, Germany, where the company is headquartered today. In the United States, Fresenius Kabi offers a broad portfolio of specialty and generic pharmaceuticals under the APP brand (www.APPpharma.com). In 2012, Fresenius Kabi acquired Fenwal Inc. (www.fenwalinc.com), expanding the Fresenius Kabi offering to include Fenwal products for transfusion medicine. These include advanced medical technologies used in blood separation, collection, filtration, storage and transfusion. Fenwal, Inc., a Fresenius Kabi company, is a global blood technology company dedicated to supporting transfusion medicine and cell therapies. We help ensure the availability, safety, and effectiveness of treatments that depend on blood ? medicine?s most vital natural resource. We currently have an opportunity for a Principal or Sr. Principal Engineer to join the Disposables team participating in product enhancements and new product development for medical devices. Responsibilities: Identify and resolve problems associated with currently commercialized disposables kits for the automated blood collection systems using engineering principles, technical analysis, and problem solving tools to resolve technical challenges and quality issues. Lead the development, implementation, and evaluation of product enhancements, quality improvements, alternate components to address component obsolescence, and manufacturing changes using change control procedures. Plan, schedule, and lead technical projects with multi-functional teams to develop and implement product / process changes to meet business goals related to quality, delivery, and cost. Lead / support disposables development activities for future blood apheresis systems. Utilize engineering techniques (such as statistical analysis, FMEA, FEA, and CFD) to identify design enhancement opportunities and assess product design. Write and execute studies following GDP and GLP, to evaluate the functional performance of products. Independently define acceptance criteria, develop and write product specifications, and test method procedures, and judge product/process acceptance to requirements....

Software Engineer II

THIS POSITION IS LOCATED IN FORT LAUDERDALE, FL Design leading edge application software for robotic orthopedic surgery to restore patients? quality of life. Stryker MAKO is an innovative medical device company located in Fort Lauderdale, FL that develops and markets both its RIO® Robotic Arm Interactive Orthopedic System and proprietary RESTORIS® family of implants. RIO enables surgeons to conduct a procedure called MAKOplasty®, providing a minimally invasive method for knee resurfacing. RIO also enables a procedure for Total Hip Arthroplasty, producing a degree of precision in acetabular cup placement unmatched by manual methods. MAKO?s software engineers develop the next generation of orthopedic application solutions that are changing how knee and hip surgeries are performed. The software development team is diverse and international with varied backgrounds, including Biomedical Engineering and Computer Science professionals. The engineers work in areas such as image processing, network communication, UI design, 3D visualization, advanced algorithms for implant planning, and many others. At MAKO, engineers are given significant opportunities for learning in the area of medical device software development. Engineers interact widely with various functions throughout the organization, as well as with surgeons and other clinical users. Additionally, engineers observe live cases in the operating room and participate in clinical labs and conferences. The engineer's primary responsibility is to design, develop and maintain application software for robot assisted surgery products. The engineer works closely with peers in software engineering and project and product management in developing software that meets the needs of patients, surgeons and the hospital community. Following defined design practices and the use of sound software engineering principles, the engineer ensures that the application software products are safe, robust and user friendly. MAKO Surgical Corp offers excellent benefits including medical, dental, life, STD/LTD, 401K, ESPP, PTO, and holiday pay....

Operations Manager

OPERATIONS MANAGER NEEDED!!! Job Description: This is a GREAT OPPORTUNITY to become a leader in a great company, and growingcorporation. In this position you will be responsible for the effectivesupervision of engineering services. You will ensure a high level ofengineering is attained, and that quality and service is maintained with theclient. Management of client relations, employees and customer satisfaction,program quality standards, performance improvement, personnel performance andproductivity is included. You will be responsible for the overall planning, andorganizing. If you are looking for a rewarding career where you can make a difference, Ourclient is the place for you. We are looking for energetic, passionate andcareer minded people to join our team and help grow our business. Requirements: BS Engineering (Biomedical and aerospace are not applicable) 10+ years experience in managing multidisciplinary engineering projects in the heavy industrial market Understanding of industrial safety requirements Excellent communication skills both verbal and written Ability to work closely with the client to establish project scope, schedule, performance and cost objectives for engineering projects Ability to develop engineering services proposals, establishing and controlling engineering project budget Team player with good interpersonal skills Ability to coordinate internally with the engineering design group including process, mechanical, piping, electrical, controls and civil/structural engineers as well as outside consultants...

Senior Staff Imaging Scientist

Position Summary: Develop, verify and integrate Image analysis and Classification Algorithms for body fluids diagnostic systems. Implement, validate and maintain processing and analysis software tools and packages for body fluids diagnostic systems. Develop, verify and integrate Image Analysis Algorithms for body fluids diagnostic systems using prototyping tools in MATLAB and C/C++. Develop and Validate efficient implementations of the algorithms in C/C++. Develop, verify and integrate Classification Algorithms for body fluids diagnostic systems using prototyping tools in MATLAB and C++. Design, implement and maintain image analysis software tools and packages for recognizing and counting particles in body fluids. Design, implement and maintain data analysis software tools and packages for image patterns recognition and diagnostic applications Develop software implementing image processing and analysis software tools and packages following BECKMAN.COULTER-IRIS development standards for documentation, traceability, verification and validation. Implement particle recognition and counting algorithms in final validated software/firmware packages deliverable to the product software group. Verify software effectiveness and reliability and produce software verification reports. Maintain and enhance the capability of the image analysis, particle recognition and the counting software tools and packages....

Director Facilities, Facilities/Plant Operations, Full Time, Days, 8 hour

Position Summary: Plans, coordinates and administers the daily activities of the Engineering and Biomedical Engineering responsibilities in accordance with applicable codes, state, and local governmental agencies, Healthcare Facilities Accreditation Program (HFAP) and The Joint Commission (TJC). Director serves as the Medical Center Safety Officer, coordinating the safety management program as required by the TJC, serves as the Medial Center Construction Coordinator for all construction projects. Director manages the Medical Center Preventive Maintenance Program for all patient care and non-patient equipment. Minimum Qualifications ¨ Education Bachelor?s degree in Business or Healthcare related field or equivalent from four year college or technical school. ¨ Experience Three to five years progressive healthcare managerial experience and/or training; or with knowledge in finance, economics, quality assurance and regulatory compliance experience. ¨ License / Certification Preferred Certified Healthcare Facilities Manager (CHFM) ¨ Knowledge/skills/abilities Excellent oral and written communication skills...

Corporate Director - Clinical Engineering - Sinai

Facility: A member of LifeBridge Health, Sinai Hospital of Baltimore features state-of-the-art facilities, national acclaim, and renowned Centers of Excellence. Sinai is the largest community hospital and third largest teaching hospital in MD. EEO/AA Employer. Job Corporate position. Responsible for planning, coordinating, and directing the daily activities of the Clinical Engineering Department....

NJ/PROJECT MANAGER-INTER/3080308

** LOOKING FOR SOMEONE WITH 3-5 YEARS EXPERIENCE ** CONTRACT IS FORECASTED TO LAST ONE YEAR ** Manages the entire project life cycle from project definition through implementation. Accountable for meeting agreed upon scope, cost, schedule and quality measures. Develops project plan and drives project milestones. Establishes effective communication plan with project team and key stakeholders. Provides day-to-day direction to project resources. Ensures effective change management occurs throughout the course of the project. Responsible for preparation of documentation, status reports and budgets. Role requires excellent oral and written communications, interpersonal, negotiation, project planning, judgment, leadership, decision-making, analysis and problem-solving skills. Expert knowledge of MS Project, Excel, MS Word and Visio. This person would need a background in mechanical, biomedical, or systems engineering. Also open to an intermediate level of experience 2-5 years. Candidate will need recent experience working for a medical device, medical regulated company. Design Controls a plus....

Senior Product Development Engineer

Job Summary: Position will direct, coordinate, and exercisefunctional authority for planning, control, integration, and completion ofdevelopment engineering tasks within area of assigned responsibility byperforming the following duties personally or through cooperation with teammembers 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....

Senior Product Development Engineer - Sports Medicine

Job Summary: Position will direct, coordinate, and exercisefunctional authority for planning, control, integration, and completion ofdevelopment engineering tasks within area of assigned responsibility byperforming the following duties personally or through cooperation with teammembers 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 aself-starter requiring minimal supervision to accomplish assigned tasks. Independently solves practical problems and deals with a variety of concretevariables in situations....

Principal Engineer

Affinity Resources is currently looking for Principal Engineer for a client located in Miami Lakes, FL . This is a permanent position paying $100,000 - $110,000 annually. POSITION SUMMARY: The Principal Engineer will be responsible for the design and development of new implantable medical device mechanical subsystems and components and providing production support related to design changes for all implantable medical device mechanical subsystems and components. Working Hours: 8:00am - 5:00pm ESSENTIAL JOB FUNCTIONS : Development of new mechanical subsystems and components. Lead design activities on assigned projects in collaboration with other department engineers. Interface with customers during exchange of technical information. Responsible for guiding engineers to ensure design practices are used consistently. Coach and direct Design Engineers and Senior Engineers. Ensure design standards are met and/or applied. Define design standards where applicable. Subject Matter Expert - Provide technical expertise to other departments, i.e. Manufacturing, Marketing, Regulatory, Quality Assurance, Program Management, etc. Support development testing and failure investigation of legacy and new products. Work with Manufacturing Process Engineering, and Quality Assurance Engineering to lead design engineering team through design changes required to maintain product supply, including verification and implementation phases. Support Manufacturing engineering, Production and Quality Assurance though production or supplier issues. Design Engineering liaison to vendors in procurement of components, sub ?assemblies and contract services. Develop project documentation within the scope of Design Controls for the design and development of heart assist pump projects. Develop project schedules and identify resource requirements to meet continuity of supple objectives. Work closely with Regulatory Affairs for submissions to appropriate worldwide regulatory agencies as part of Implementation phase. Work with technical staff, Quality Assurance, Clinical Affairs and Regulatory in the development of Risk Management process as part of the change/improvement process and based on return analysis results. Mentoring of less-experienced engineers....

Sr. Product Development Engineer

Job Classification: Full-Time Regular Connect confidentially with MRIGlobalMedDevice at: Our client is a worldwide industry leader in manufacturing spinal implant products. Great location and awesome benefits! Essential job responsibilities include, but are not limited to: Manage cross-functional teams for the development of new implants and instrumentation for spine surgery Perform R&D management of multiple projects, budget and timeline utilizing appropriate tools and software. Project budget and timeline responsibility Coordinate product design input, output, verification, validation and risk analysis. Collaborate with external resources and vendors for product development activities. Work with clinical staff, physicians, and marketing team. Maintain design controls compliant with ISO 13485, Euro MDD, and FDA 21CFR 820....

Forensic Engineer/Injury Biomechanics Engineer

TECHSTAFF is recruiting for a Tempe company that is seeking a candidate with experience in vehicle accident reconstruction and injury biomechanics. Responsibilities: This individual will be responsible for conducting technical analysis concerning the causation of physical injuries resulting from incidents involving motor vehicles, industrial equipment, slip and falls, etc. This individual will research and analyze biomechanical issues involving kinematics, dynamics, mechanisms of injury, and human tolerance and clearly communicate these findings via written reports and/or presentations. This individual will also conduct research and publish papers in technical journals. This individual will serve as the primary support to the expert witness....

Technical Specialist, Automation & Control

Valin Corporation, with its corporate office based in San Jose, California is one of Inc.'s 500/5000 Fastest Growing Companies is the leading technical solutions provider for the technology, energy, life sciences, natural resources, and transportation industries. Valin offers personalized order management, on-site field support, comprehensive training, and applied expert engineering services utilizing automation, fluid management, precision measurement, process heating, filtration, and fluid power products. Valin was recently recognized as the 21st Largest Private Company in Silicon Valley by the Silicon Valley/San Jose Business Journal, as well as on Industrial Distribution's Big 50 Watch List and Modern Distribution Management's Top 40 Industrial Distributors list. The following position is based in our Santa Ana, CA office. Summary : Our company is looking for a Technical Specialist, Automation Control who understands automation control technology and can work as part of our sales team towards customer solutions. Essential Functions : Develop and achieve annual sales plan. Ensure corporate sales strategy template is utilized and completed with strategic but realistic goals: Revenue, Product Mix, Market Segment and Margin. Analyze the strengths, weaknesses, opportunities and threats within assigned territory as part of the annual plan and updates quarterly. Manage time and territory to maximize opportunities within the market. Identifies and prioritizes key accounts with potential form the following market segments: electronics, semiconductor, packaging, bio-device, biomedical, transportation, aerospace, energy. Effectively balance the focus on existing accounts with prospecting activities. Identifies applications and projects within current accounts that are served by competitors and displace the competition. Understands the technical aspects of the business. Completes all provided product training and develops a plan within 30 days of completion as to utilization. . Execute a customer focused and value added sales process. Facilitates on an on-going basis the customer needs analysis and strategically works to deliver solutions beyond the product to key targeted customers and prospects. Identifies and executes a plan for educating key industrial users, machine builders, and integrators on the total automation capabilities of Valin to earn opportunities for additional sales. Sell complete turnkey automation systems: identify the project, get specified at the end user or engineering firm, engineer and design the system, partner with an integrator and supervise the project and installation for custom solution. Operates safely, legally, and ethically and professionally. Positively contributes to all sales and corporate meetings. More than 50% of your time will be working off-site at customer locations....

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