Biomedical Engineering Career Careers in the United States

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Biomedical Technician

Biomedical Technician Contract/Contract to Hire Los Angeles, CA *Subject to background and drug screen Pay range: Hourly $25 - $35/h r The Biomedical Tech II is responsible for providing data backup, recovery and security procedures. Establishes a logging procedure or facility to ensure the integrity of the database. Has responsibility for the physical management of the Biomedical Engineering data, including regulatory documentation and report production, for various committees, agencies and management presentations. Requires the installation, calibration, inspection, preventive maintenance and repair of Biomedical and related technical equipment. Involves the operation and/or supervision of equipment control, safety and maintenance. May require development and/or modification of new and existing equipment. Serves as a Technical and Supervisory resource to others in the department, regarding Biomedical Engineering equipment and associated data files....

Biomedical Technician

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

Manager Biomedical Engineering

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

Director, Biomedical Engineering

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

Intern - Biomedical Engineering

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

BIOMEDICAL REPAIR TECHNICIAN 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 REPAIR TECHNICIAN I

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

BIOMEDICAL REPAIR TECHNICIAN II

Job Description: BMET II - BIG SPRING TX 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. Texas Fire Alarm License required Manage equipment and schedule service. Perform pre-acceptance inspections and develop PM procedures on newly purchased equipment; maintain files on procedures and manuals. Ensure test equipment is working properly and calibrated within established intervals. Research and initiate orders for repair parts. Provide informal training to equipment users. Participate in the Quality Improvement/Risk Management program and make recommendations for improvement. Provide emergency on-call responsibilities as needed....

BIOMEDICAL REPAIR TECHNICIAN III

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

Biomedical Electronics Tech TEMP

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

Biomedical Equipment Technology Instructor

Job Summary The instructor facilitates meaningful learning of the course competencies in the curriculum and proactively supports all facets of the learning environment. S/He provides education through learning-centered instruction that will enable graduates to fulfill the evolving needs of the marketplace. S/He encourages a culture of learning that values mutual responsibility and respect, life-long learning and ethics as well as personal and professional development. Incumbent must assure that the EDMC philosophy: quality services to clients; development, growth, involvement, and recognition of employees; sound economic principles; and environment which is conducive to innovation, positive thinking and expansion - is considered in carrying out the duties and responsibilities of this position. Key Job Elements Provides competency-based education which aligns with the EDMC model of curricula as well as supports the EDMC style of system delivery. Designs and delivers class instruction through the development of instructional plans to meet course competencies, the development of activities which support lesson objectives, and (in the case of online instructors ONLY) delivers the instruction as approved. Enables the achievement of pre-described exit competencies for student achievement and evaluation of learning by providing instruction which fosters competencies and establish student performance criteria and evaluation. Delivers learning-centered instruction by establishing a classroom environment conducive to learning and student involvement as well as effectively planning and preparing for classes and student success. Promotes student success by showing flexibility in style and work schedule as well as exhibiting a passion for teaching and students and engaging students in the learning process. Manages the learning environment through keeping accurate records, submitting grades and other reports on time, and enforcing school/campus academic and attendance policies. Contributes to a learning culture by participating on curriculum and system task forces, supporting local campus events such as orientation and graduation, and participating in various other workshops and meetings. Relates professional/life/industry experience to learning by the continuation of professional/technical skills development, the introduction of industry perspective into courses, and the active awareness of professional/industry trends and opportunities. Reports To: Dean of Academic Affairs, Academic Department Director Directly Supervises: None Interacts With: Academic Affairs Department, Other school/campus functional areas, Curriculum Task Force and other committees, other faculty, and students Job Requirements Knowledge: Master's degree in electronics or electrical engineering or a Master's degree in Biomedical Engineering and three (3) experience in a related field. One to three years experience in instruction or formalized education process, preferably in a post-secondary or college institution. Membership in a professional association tied to area of instruction preferred. Skills: Excellent verbal and written communication skills including the ability to build successful relationships with student populations. Outstanding conflict resolution skills. Demonstrated time management and detail-oriented skills Computer based skills (i.e., software, analytical, and report writing skills) Abilities: Ability to work effectively under pressure and to meet frequently occurring deadlines. Ability to develop a professional rapport with diverse school/campus constituents. Ability to develop and complete projects without continued direct supervision Ability to learn from students' participation, demonstrates fair and consistent behavior in all matters, and shows compassion without being ineffectual...

GDC Engineering Lead 606542 (NCI) Job

GDC Engineering Lead 606542 (NCI) (Job Number:606542) Description: PROGRAM DESCRIPTION Leidos Biomedical Research Inc. is supporting the National Cancer Institute by providing oversight to a subcontractor developing the next generation genomics database for NCI called the Genomics Data Commons (GDC). JOB DESCRIPTION The GDC Engineering lead will assess the engineering practices of the subcontractor to ensure that industry standard software processes are employed, the engineering lifecycle model used is appropriate, and processes are being followed. Will assist in evaluating technology choices and evaluating the GDC subcontractor IT solutions including architecture, design, implementation, and hosting. In addition, may assist the Leidos Biomed GDC Senior Principal Scientist and subcontractor in translation of scientific requirements into system and software requirements and assist the Technical Project Manager II and subcontractor in incorporating these in project schedules. Will also help coordinate with external organizations for deployment and hosting of GDC systems if necessary. Qualifications : BASIC QUALIFICATIONS - Possession of a Master's degree from an accredited college/university in biomedical science, physics, computer science, engineering and/or related field or six (6) years equivalent experience in lieu of degree. - Foreign degrees must be evaluated for US equivalency. - In addition to educational requirements, a minimum of six (6) years of progressively responsible job related experience including two (2) years of experience in a leadership capacity. - Experience with designing information and data models. - Experience with the design of web services including RESTful services. - Experience with database technologies and associated database client tools. - Experience with bioinformatics systems. - Knowledge of 508 Compliance. - Ability to communicate effectively with all levels of scientific personnel and administrative staff through written and oral presentations. - This position is subject to obtaining a Public Trust Clearance. PREFERRED QUALIFICATIONS - Experience with polyglot data architectures. - Experience developing solutions for large scale (PB) data sets. - Knowledge of cloud technologies and architectures. - Knowledge of HW/Network and Data Center environments for hosting large scale systems. Leidos Biomedical Research, Inc., a wholly owned subsidiary of Leidos, operates the Frederick National Laboratory for Cancer Research, sponsored by the National Cancer Institute. Our focus is on basic and applied science in cancer and AIDS. We maintain an integrated suite of advanced technologies backed by scientific expertise in areas such as genetics, genomics, protein science, proteomics, bioinformatics, high-performance biomedical computing, and nanotechnology. We develop new technologies to support cutting-edge science, and we develop and manufacture clinical-grade pharmaceuticals for first-in-human trials. Leidos Overview:Leidos is an applied solutions company focused on markets that are seeing converging business and technological trends, and address basic, enduring human needs: defense and national security, health and life sciences, and energy, engineering and infrastructure. The Company's approximately 20,000 employees serve customers in the U.S. Department of Defense, the intelligence community, the U.S. Department of Homeland Security, other U.S. Government civil agencies and commercial health and engineering markets. Leidos is an Equal Opportunity Employer M/F/D/V. Job Posting: Jun 23, 2014, 1:58:31 PM Primary Location: United States-MD-ROCKVILLE Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: Public Trust Potential for Teleworking: No Travel: None Shift: Day Job Schedule: Full-time...

BIOMEDICAL ENGINEERING - FIELD SERVICE SPECIALIST III

To administer the daily operations of the hospital?s Nurse Call System and provide automation equipment repair and maintenance (HVAC, Tube Systems, Energy Mgt. Systems, Alarm Systems, Emergency Power Systems, etc.), perform substantial maintenance, safety testing and routine repairs....

Biomedical Technician (Electronic)

Job Classification: Contract Qualifications -Assemble and troubleshoot systems that house printed circuit boards, mechanical assemblies, and other features-*The manufacturing technician will not be responsible for debugging problems; they will only be responsible for testing the equipment/systems. The engineers will be responsible for debugging and fixing any malfunctions/errors.-Follow standard operating procedures for assemblies-Perform basic circuit troubleshooting using a voltmeter and circuit diagram when necessary-Make qualitative/quantitative assessments using a microscope or stereoscope-Perform assembly tasks in a repeatable manner with consistent results that are focused on quality-Perform general shop maintenance and upkeep-Communicate with team members and demonstrate ability to accomplish tasks and goals-Experience with basic hand tools such as: screwdriver, wrench, soldering iron-Knowledge of Excel, Word, Powerpoint and general PC skills-Ability to analyze results from computer testing and communicate these results with engineering coworkers **An Associate's Degree in a relevant field (electronic technology, electronic systems) is preferred but not mandatory (experience can replace this)****The ability to solder is also preferred but not mandatory - they use thru-hole and fine-pitch soldering techniques under a microscope** The company designs, develops, and manufactures instrumentation systems to model complex human systems. Their primary instrumentation system allows the testing of pharmaceutical drugs and provides quicker, safer results. The manufacturing technician will help assemble and test instrumentation equipment and consumables (MEMS). Candidates will not be manufacturing printed circuit boards; all PCBs are brought in from an outside manufacturer. Join Aerotek Commercial Staffing &#174 . We employ people in light industrial, light technical and office support positions across the nation. If you are looking for a competitive wage, solid opportunity, and a career path to success, contact us now! We offer comprehensive benefits to include medical, dental, optical, and optional 401k. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Commercial Staffing 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....

BIOMEDICAL ENGINEERING - AUTOMATION SPECIALIST

The Building Automation Technician is responsible for monitoring various critical hospital systems, taking telephone calls from staff, physicians, visitors, and patients, and dispatching calls for service to various departments....

Engineer- Medical Device

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

Healthcare Technology Engineer (Project Officer/Biomedical Engineer)

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

BIOMEDICAL ENGINEERING - SENIOR BMET, FULL TIME

Under general supervision, this position provides medical equipment repair and maintenance, performing substantial maintenance, safety testing and routine repairs....

Security Engineer

Job Classification: Contract The Security Engineer will perform security assessments to determine a project?s potential gaps in compliance with internal Data Security policies and standards. Security Engineers contribute to technical designs to help ensure adherence to security best practices. In addition to being accountable to direct line management, the Security Engineer will be accountable to and take direction from the IT Security Director and IT Technology and Infrastructure Vice President. The Security Engineer will directly interface with other Information Security Engineers and IT's internal customers at the Manager and Director levels. This position will assess the problem and deliver a solution, not just an audit on what is wrong on non compliant. CERTS: CISSP good, other helpful or equivalent experience. MUST BE WEST COAST, will work on MST (AZ) time so they greatly prefer west coast folks. Responsibilities / Functions: - Conduct Risk Assessments: Communicates risk, security metrics and security concerns to business owners and IT leadership for - Dignity Health data assets - 3rd-party solutions - 3rd-party enterprise security (policies, procedures, practices, safeguards, controls, etc.)for all types of business partners: ASP, SAS, cloud, myriad service providers - Follow the Information Risk Assessment practice and processes for internal and external assessments to include - Capability analysis - Gap analysis - Compliance with company policy and/or external standards and statutes - Partner with leadership and business owners to identify, consult on, mitigate, and design remediation for risk issues in context of compliance and best practices. - Act as technical resource for requirements development, diligence, and implementation of risk management and security-related solutions. Qualifications: Knowledge of:-PCI Compliance-Biomedical Devices ? these were mentioned specifically on the call. - IT security domains, components, principles, procedures and practices - Web applications and Internet security - Information security controls and IT audit methodology - Operating systems and applications - Project management concepts and techniques - Functional understanding of regulatory and compliance mandates, including but not limited to HIPAA, HITECH, PCI, Sarbanes-Oxley preferred. - Bachelor?s Degree in Computer Science , Information Security, Information Systems, or related field, or equivalent professional experience required. - CISSP or equivalency in technical data security - Experience in Windows Office (Work, Excel, etc) required. - Must communicate professionally and effectively in written or oral format. - Strong interpersonal and relationship-building skills, with the ability to communicate up, down and across levels of the organization. - Proven ability to think analytically and solve technical and business problems required. Join TEKsystems ® and get your career on the fast track. As the leading technology staffing and services firm, we are passionate about deploying high-caliber IT and communications expertise. To satisfy our constant need for expertise, we actively seek talented Technical Professionals with all levels of information technology and communications skills. TEKsystems knows that every professional has different needs, so we'll work together to determine a suitable benefits package. We offer options to our Technical Professionals that could include: a health plan, 401k, provisions for vacation and holiday pay, and technical and professional training. With a foundation as the nation's largest IT staffing firm, we've become a billion-dollar services company by blending superior client service with an unrivaled ability to source and manage talent to precise specifications, resulting in successful technology executions. Allegis Group and its subsidiaries are equal opportunity employers. M/F/D/V...

Manufacturing Engineering Manager - New Product Introduction

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

Sr Validation Engineers ? Project based - Draper UT

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

Field Service Engineer MEM

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

Senior Engineer, New Product Development

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

Utility Operator/Stationary Engineer (4396)

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

Sr. Mechanical Engineer

SR./STAFF MECHANICAL ENGINEER - MEDICAL DEVICES Do you: Want to work on technical challenging projects? Crave the opportunity to learn new things? Want to have control over what direction your career turns? Then you should work at Moog, Inc. - a global organization that operates in 23 countries. Our expertise lies in applying advanced technologies to the precision control of motion and fluids. Underlying this expertise is a set of values and beliefs that guides our actions: we pride ourselves on solving challenging problems that make a difference; we strive to be flexible to our customers? unique needs; we do what we say we?ll do; and we believe close working relationships provide better results. We are the Medical Devices Group who designs, manufactures, and distributes industry-leading enteral feeding, infusion, and post-operative pain management pumps, fluid sensing and control solutions, and surgical hand pieces. We have a current openings for a Mechanical Engineer who has a BS/MS in Mechanical/Biomedical Engineering, and at least 7 years of experience Our culture is based striving for mutual trust and respect, and we hire capable people and let them do their jobs. This position is located in Salt Lake City, Utah . Sound good? Here?s the details: Core Responsibilities: Reporting to the Site Engineering Manager, this position is responsible to ensure the highest possible professional standards and integrity are maintained in the development of electromechanical medical devices. Responsible for developing products within a regulated framework. This involves defining tasks and objectives and ensuring the most efficient use of company resources to meet these goals. This position will also ensure all project-related documentation; including writing test and assembly procedures and initiating Engineering Change Orders (ECO?s) are completed timely and accurately. Project Management ? Serves as engineering team member for the disposable sets portion of related enteral and intravenous pump design and development projects. ? Conducts feasibility studies, identifies engineering tasks and cost estimates, identify technical risks and mitigations ? Establishes and maintains schedules for own deliverables, including tasks and completion milestones. ? Ensure that product development goals are met. ? Confers with supervisor and/or technical leads on unusual matters, reports at regular interval to project leaders on activities/problems/plans ? Time and project management with the ability to manage multiple priorities. ? Works effectively with designers at contracted companies and affiliated organizations ? Works effectively with designers at contracted companies and affiliated organizations. Technical ? Document and review designs using the established development process, including but not limited to high level design, design specifications, design verification, test specifications, and traceability. ? Work with mechanical, software, and manufacturing teams to reach consensus on difficult system-level tradeoffs. ? System Integration ? Problem Solving and Innovation - Provides root cause analysis and design solutions for system level issues. ? Determines and implements the closure of specific corrective actions. ? Involved with device safety and hazard analysis activities. ? Ensure and create as needed, engineering processes, practices to ensure compliance with various standards and regulatory requirements. Work with technicians in evaluating and testing concepts. ? Monitor technology trends such as emerging standards for new technology opportunities. What talents and abilities you will bring with you? ? BS/MS in Mechanical or Biomedical Engineering ? Minimum of 9 years related experience. ? Understanding of concept-to-production engineering, including high level design, detailed design, prototype assembly logistics, lab debugging, system integration, design verification, and manufacturing handoff. ? Complete understanding of technical principle, theories, and concepts in the field of engineering. ? Independently determines and develops approach to solutions. ? Excellent communication skills, written and verbal, enthusiastic, motivated and self-driven. Benefits: Moog Medical Devices Group offers a wide range of benefits, including, comprehensive medical and dental insurance at competitive rates, life insurance, short and long term disability insurances, 401(k) plan with a company match, generous paid time off policy for work life balance, and the opportunity to work in a team environment. How to Apply: If you are interested in joining a team of passionate engineers, and have what it takes to make a positive impact in the lives of the patients we serve, submit your resume via the Moog online Career Center located at: www.moog.com . The requisition number for this position is: 14-10686 EOE/AA Minority/Female/Disability/Veteran #CB...

PRODUCT DEVELOPMENT ENGINEERS

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

Supplier Quality Engineer

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

Product Development Engineer II (EE)

The Product Development Engineer II will develop new ultrasound medical devices to support current and future company products and will participate in the manufacturing, testing, servicing, and documentation of products. Duties and Responsibilities: ? Design electronics, perform circuit simulation, layout and build/test/debug ? Develop hardware/software interface ? Complete design documentation (BOM, engineering change requests, engineering file,schematics, layout, supplier info, user manuals, test specifications, etc.) ? Develop jigs, tools, equipment, etc., and accompanying instructions and documentation ? Assist current and future company R&D efforts ? Assist manufacturing and field service staff with technical problems and questions ? Propose and support testing of product improvements and design changes ? Assist manufacturing with testing and troubleshooting during startup of manufacturing ? Provide limited field service support, as required ? Contribute to projects within a cross-functional team environment...

Principal Design Engineer - Medical

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

Project Engineer

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

Quality/Process Engineer

Job Classification: Full-Time Regular Connect confidentially with MRIGlobalMedDevice at: This is a visible position and is a great opportunity to make your mark. This organization is positioned for huge growth and this is a ground floor opportunity to make a tremendous impact in the company?s future. To be considered for this position, the following is required (unless otherwise specified): BS ME or Biomedical 3+yrs within medical-ANY?prefer laparoscopic or disposable Exp working process from development to production to sustaining Design control experience Process/equipment validation experience Suppler audit & CAPA experience CAD Essential job responsibilities include, but are not limited to: Provides quality and process engineering expertise to the organization while ensuring conformance to the quality management system (QMS), FDA and international regulations, and applicable standards. Assists cross-functional teams with the development of new products and the maintenance of existing product lines. Establishes and implements process improvement projects to drive customer satisfaction, maintain an effective QMS, and improve business productivity. Drives validation projects and documentation, develops and revises QMS documents, reviews validation and production reports/records. Implements a global manufacturing footprint as warranted by evolving customer demands worldwide. If you experience technical difficulties when applying to this position, please email your resume directly to...

Post Market Risk Management Engineer-US - NY - Rochester - CNP

Ortho-Clinical Diagnostics, Inc. (OCD) is a leading provider of in vitro diagnostic products and services, offering accurate, timely, and cost-effective solutions for screening, diagnosing, monitoring and confirming diseases. The company has approximately 3,800 employees around the world serving the global clinical laboratory and transfusion medicine community, and is committed to providing customers with products, services and process solutions to make labs more efficient in delivering the quality test results doctors and patients need. OCD was recently acquired by global alternative asset manager The Carlyle Group as an independent, freestanding company. With new leadership and accelerated investment in research and development, OCD is well positioned for growth as a leading player in the global diagnostics market, tapping into rising demand for sophisticated medical diagnostic products and services worldwide. Ortho Clinical Diagnostics, a global company, is recruiting for a Post Market Risk Management Engineer to be located in Rochester, New York. This is a highly independent role performing analysis of customer complaint data and identifying product quality trends; providing data & insight for investigations and resolution of product quality issues across all WW LoBs for OCD. The role requires an oversight of complaint vigilance, regulatory compliance and escalation of post market quality issues. A key feature of this senior role is to ensure that active programs of work are in place to prevent future recalls/field actions; and for these programs to be identified and driven through analysis of actual and potential risks. The incumbent is expected to operate at a senior level and to interface directly with WW Health Authorities. This role also has the responsibility for developing and overseeing processes for driving post-market information assessment and potential impact to marketed products (e.g. labeling changes, identification and assessment of new risks) and for ensuring that product risk management files are updated (by appropriate owners) on a periodic basis. The latter aspect of this role is viewed as complimentary to risk pre-market risk management. As a subject matter expert for the recalls / FSCAs / escalation processes and post market risk management the role holder will provide support for audit/inspection support for internal/external/regulatory inspections. Overseeing the Product Quality Review (Escalation) process including issue consultation and classification while liaising with senior company and corporate management, Legal and WW Health Authorities*. Overseeing Health Hazard Evaluation development, recording inputs and outputs of process to help assure efficient review of issues as well as to assure an audit ready state of the records (including content and timeliness of the records)*. Manage and maintain a worldwide process for product risk management files for all launched products (across all LoB's) and to ensure that they are reviewed on a periodic basis and updated as appropriate in light of newly identified risks or changes in use or changes in risk: benefit ratio*. Leading and demonstrating effectiveness of Field Action Review Board for all reportable field actions and near misses. Responsibilities include: tracking issues, assuring timely progress of Root Cause Investigations and CAPA development, participate on the Life Cycle Management Teams, monitor Health Authority web sites for current and emerging trends and data comparisons. Assist with the management and maintenance of worldwide recall/FSCA, etc. and associated records (for all company sites and lines of businesses) that comply with requirements of FDAs corrections and removals (recall) regulations and Corporate Policies to protect the company from adverse regulatory action. Managing or writing FDA notification reports (initial and all follow-ups) within regulated timeframes to assure compliance with federal regulations. Being primary liaison with FDA, WW Health Authorities, OCD and Corporate Management to help assure effective and timely response to any inquiries made. Supporting OCD affiliates worldwide when they report recalls to their Regulatory Authorities*. Managing foreign affiliate and US follow-up communication processes. Assisting in the development of recall implementation plans to assure compliance with worldwide regulations*. Qualifications Degree qualified in Quality, Regulatory or Scientific discipline (e.g. Biomedical, biochemistry, analytical chemistry 5 years experience in a quality/regulatory/healthcare environment Must have knowledge of NC, RCI, CAPA processes Must be able to demonstrate experience in data analysis and presentation Must have front room experience in HA audit / regulatory inspections Basic statistical and data analysis skills Previous WW HA reporting / interaction is desirable...

Embedded Systems - Firmware Engineer

As a member of the company?s engineering team, new team members will take an active role in the development and commercialization of electronic devices based on proprietary technologies.The Firmware Engineer role centers around design and development of micro-controller based embedded systems. Some responsibilities include: Firmware development API development Development of engineering boards and SDK?s Development of Host Applications and GUI?s. Candidates with experience in the following fields are welcome to apply: biomedical electronics, computer peripherals, RTOS systems, signal acquisition systems or sensors, mixed signal systems, or related fields. This is a Direct Hire position in Bellevue, WA and is offered through Volt Workforce Solutions which is located in Auburn, WA. We are among the largest Staffing Companies in the US for contingent/temporary and direct hire placements, and support many of the top rated Pacific Northwest companies....

Mechanical Engineer - Cook Inc

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

Software Quality Engineer III

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

Field Service Engineer - Seattle Area

Field Service Engineer ? Medical Devices Kelly Engineering Resources is working closely with a medical device manufacturer to hire a Field Service Engineer for the Seattle area. The Field Service Engineer will be responsible for maintaining magnetic mapping devices used in cardiology surgical applications. The FSE will install, maintain, troubleshoot and repair sophisticated equipment at customer sites. This contract assignment will be for 1 year, and could lead to direct employment with a major healthcare company. The pay rate will be $30.00 per hour. The successful candidate must have reliable personal transportation to travel to local customer sites, and must be willing to travel throughout the country for training. Product training and on-the-job training will be provided by the company. All travel-related expenses will be reimbursed. Qualifications: - Bachelors degree in Biomedical Engineering, Electrical Engineering, Electronics Engineering or a related field will be required. - 2 ? 5 years experience is desired, but not required. Recent graduates will be strongly considered. - Must be able to travel up to 50% of the time. Important information: This position is recruited by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must submit your resume online . If you have questions about the position, you may contact the recruiter recruiting for this position at . You must be authorized to work in the United States. In addition to working with the world?s most recognized and trusted name in staffing, Kelly employees can expect: Competitive pay Paid holidays Year-end bonus program Recognition and incentive programs Access to continuing education via the Kelly Learning Center About Kelly Services ® Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly ® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis. Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion. [Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter . Download WorkWire ? , a free career and employment resource iPad® app by Kelly Services.] iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc. Since employing its first engineer in 1965, the Kelly engineering specialty has grown to be recognized as a leading provider of engineering resources to customers in such industries as automotive, chemical, defense, electronics, energy, medical device and pharmaceutical. Want more information? Visit kellyservices.com/engineering Connect with us on...

Consulting Electronic Design Engineer

A Senior Electronic Design Engineer is needed for a long term contract opportunity with Yoh's client located in Brea, CA. What You'll Be Doing: The main goal for this position is to redesign and recommend a circuit board design that could lead to cost savings. PCB Design knowledge or experience in a regulated medical device / biotech environment is critical. There will be a focus on Consultative Engineering: driving business strategy and working with different business units in cost savings and feasibility of design. What You Need to Bring to the Table: Analog and Digital Design Experience Analog design in low noise, high sensitivity signal processing, including Analog to Digital conversion and Digital to Analog signal conversion. Motion control experience in servo motors and stepper motors is desirable. Design experience in photodiode, PMT circuit, sensor interface is a plus. Digital design using embedded microcontroller, microprocessor, memory, programmable devices including FPGA and PLD. Firmware and software experience is also desirable. Schematic capture and PCB layout CAD tools experience. Candidate should be able to analyze/evaluate the current design, look for opportunities to redesign for cost reduction and components obsolescence (End of Life) avoidance. What's In It For You? Our client develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Their diagnostic systems are found in hospitals and other critical care settings around the world and produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Be a part of this team! If this looks like you, Apply Now! Recruiter: James Dangler Phone Number: 585-327-7475 Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here! Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. J2W: ENG...

Injection Molding Process Engineer

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

Embedded Software Engineer w/ Bluetooth or BLE

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

Sr. Product Development Engineer

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

Embedded Software Engineer-4315

Start Date : 4/7/2014 End Date : 10/3/2014 Location : Northridge, CA USA LOCALS ONLY REQUIRED QUALIFICATIONS: Candidate must have a BS in Computer Science, Computer Engineering, or Electrical Engineering or BS in Biomedical Engineering with a software or electrical focus. Minimum 5 years of software design and implementation, be proficient in C and/or Python, have embedded software development experience, preferably using embedded C on low-power microcontrollers. They must have good oral and written communication skills. POSITION RESPONSIBILITIES: Interpret, understand and provide feedback on software requirements for a project. Perform requirement analysis to determine completeness and compliance with software system. Ability to work with requirement management tools. Responsible for delivery of high quality code for a subsystem or project. Code is consistently well-documented and maintainable. Use appropriate tools to support code development. Perform all aspects of software development, including specification, design, and implementation of embedded and PC-based software per Medtronic Diabetes software development procedure. Write and execute comprehensive unit and integration tests to meet quality expectations. Understand appropriate verification practices and tools. Support Hardware/software integration and software validation....

Product Development Engineer (IRC4659)

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

Field Sales Manager

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

Principal Modelling Engineer

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

Senior Electrical Engineer/Manager - Robotics

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

Senior Manufacturing Engineer

Manufacturing Engineering ? Focus ensuring quality and efficiency through manufacturing processes Engineering applies research and principles of engineering to the planning, design, development, documentation, and testing/debugging of a variety of instruments, equipment, systems and/or software. Develops solutions to meet customer needs. Develops technical specifications and definition of system interfaces. Defines approaches to implementation and operation. Models operational environments and performs effectiveness analysis. Ensures design meets specifications and fulfills its intended purpose. Collaborates with other functional groups, including Manufacturing, Quality, Marketing, and Science. Ensures company, industry, and regulatory standards are met. Engineers must have degree in Engineering (CQE designation for QA Engineers). ? Responsible for establishing and expanding Process Monitoring requirements within Miami Hardware and Reagents Operations. This position directly supports operations by oversight of Statistical Process Control (SPC) teams for each Value Stream, providing analysis and generating when required mandated quality reports that are inputs for CAPA Eligibility. ? Knowledgeable in the application of statistical analysis to drive Variable Statistical process Control throughout the organization in an intelligent manner that identifies and understands opportunities that impact product and operational quality through the systematic variation reduction. ? Activities include establishing data collection plans. Conduct data exploration to gauge process stability, process capability and establish Critical to Quality (CTQ) parameters. Provide team support establishing and interpreting run charts. ? Contribute technical analysis and leadership to Product Development and new product introduction activities. Participate on new product development teams to provide DFM analysis and process capability targets for process/equipment development and manufacturing process transfer into production per applicable regulations and quality system requirements. ? Partner with Validation to establish data collection plans and statistical studies to support process validation protocol development, conduct process optimization studies, conduct process verifications and validations, and generate verification and validation reports. ? Assures product and process quality by collecting, analyzing, and summarizing information and trends; monitoring finished- product testing and process capabilities; establishing standards; confirming manufacturing processes....

Principle Design Engineer

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

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

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

Mechancial Designer/ Designer/ Drafter

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

Project Engineer, JR

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

Director of Plant Operations

FULL TIME OFFERING COMPETITIVE BENEFITS Los Angeles based hospital system is searching for a Plant Operations Director. The Director ofPlant Operations is responsible for the direct supervision of all department personnel including the staff engineers, and biomedical technicians. Theapplicant must be able to carry out supervisory responsibilities in accordancewith the organization?s policies & procedusres and applicable laws. Responsibilities include interviewing, hiring,and training employees; planning, assigning, and directing work; appraisingperformance; rewarding and disciplining employees; addressing complaints andresolving problems. The Director of Plant Operations is responsible for thesupervision, maintenance and operation of all buildings, structures and supporting equipment. The Director of Plant Operations will also be responsible for the successful planning and completion of pending hospital projects....

Field Service Engineer (215260-017)

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

Test Systems Engineer

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

Sr. Engineer

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

Manager, Visual Inspection Engineer

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

Mechanical Project Co-op

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

Principal Process Engineer

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

Human Factors Analyst - Entry level

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

Software Engineer I-II

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

Senior Product Development Engineer - Sports Medicine

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

Aerospace & Operational Physiology (AOP) Curriculum Developer

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

Validation Engineer - Decommissioning

PSC Biotech has a need for a Decommissioning/Validation Engineer for a long term project (9 months with possibility of extension) in the New Jersey area. Responsibilities Validation engineer (2-8 yrs exp) Commissioning and Decommissioning experience required Decommissioning engineer must have the ability to develop decommissioning protocols (IQ/OQ), decommissioning reports, and test documents. Decommissioning facilities/utilities/equipment knowledge Conducting audits/gap assessments Must have the ability to write and review decommissioning plans for lab equipment Strong knowledge of Empower software (Chromatography Data Software ? CDS) Located in New Jersey area...

Business Systems Analyst

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

Electrical Coordinator

NSTAR Global Services A Company of the M+W Group Electrical Coordinator/Technician Location: Santa Clara, CA Position Type: Full time Schedule: Must be open to working any shift/schedule: days, nights, weekends, holidays, etc. Steady shift will be determined at time of hire. Other compensation: We offer Benefits such as Health, Dental, Vision insurance, 401K, Annual sick leave, Vacation time, Paid holidays, Overtime Pay, Referral Bonuses, Loyalty Rewards Position Summary: The Electrical Coordinator/Technician will be responsible for managing the Commissioning/Decommissioning process of base build mechanical electrical and room ready, processes equipment and systems on advanced semiconductor manufacturing facilities. As an Electrical Coordinator you will be participating in the development of Commissioning/Decommissioning Processes, schedule integration, project safety, compile Critical Success Indicators (CSI?s), identify budge and Project Construction Safety Performance....

Project Engineer - Medical Device

Oscor Inc. is a global US based medical device company headquartered in Palm Harbor, Florida. Oscor designs, manufactures and sells a variety of highly specialized implantable cardiac pacing leads, venous access systems and diagnostic catheters with sales to over 65 countries internationally. As a leading manufacturer of medical devices in the area of cardiology, electrophysiology and radiology, Oscor offers excellent career opportunities and great benefits within a fast-paced and challenging environment. Oscor currently has an opening for a Project Engineer. This position will be responsible for coordinating new product development according to customer specifications, developing hands-on product solutions and improving manufacturing methods, systems and processes to produce a high quality product at optimal cost. The Project Engineer manages a complete device project from the early development stage, through detailed manufacturing process development to technology transfer to production floor. Position Responsibilities Coordinates new product development with customers or according in-house requirements. Generates all required documentation in support of the development and manufacturing products and processes, including timelines, responsibilities, engineering protocols, IQ, OQ, PQ reports, bill of materials, assembling instructions, manufacturing instructions and procedures. Conducts component and device testing. Accurately generates standard written reports. Develops plans to evaluate process repeatability and stability through equipment qualification and process validation. Ensures compliance with QSR and internal protocol. Use appropriate statistical support and Design of Experiments (DOE) when developing recommendations. Designs, develops, and implements basic manufacturing fixturing and tooling. Works with internal manufacturing as well as outsourced partners to develop metrics such as labor time, yields, statistical analysis, qualification and validation of process, tooling and equipment. Provides support in the resolution of product complaints and/or safety issues. Works with various departments to facilitate pilot production of new products. Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA/QSR regulations. Transfer as required engineering project from engineering into manufacturing....

Director, Facilities Management & Engineering Services

Mercy Hospital & Medical Center, we have a rich history of providing the most advanced medical care in the Chicago area. Here, you'll find world-class medicine combined with compassion and convenience. As Chicago's first hospital, Mercy has a tradition of leadership and innovation that we invite you to share....

Process Engineer I

Process Engineer I Integrated DNA Technologies seeks a driven individual with experience in Lean and/or Six Sigma methodologies interested in working in a fast paced, innovative biotech company. Ideal candidates will be goal driven, problem solvers that take charge of projects and find ways to make significant contributions to the department and corporate objectives. We are looking for leaders who have the ability to work with multiple departments across various disciplines and levels of management to improve quality, reduce costs, and increase throughput of processes....

Production Supervisor

Production Supervisor Job General Foreman - Pittsburgh, PA - Fortune 500 company in the metals industry seeks to hire a General Foreman to lead a team of up to 12 employees. The 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. 24/6 operation. Responsibilities for the Production Supervisor Responsible for the performance of up to and including 12 hourly employees. Work from schedules tables charts, general instructions and other data and information to plan and lay out work to ensure an orderly flow of material into and out of the area that meets the customer requirements including delivering the product on time. Must assist, direct, and train team to work in a safe manner to set-up and operate the Atomizer and related equipment to produce a product that meets the customer requirements in a safe and cost effective manner. Must continually involve all employees in search for ways to improve Safety, Quality, Lean Manufacturing Processes and On Time delivery performance. Responsible for certification and re-certification of all employees for each skill in critical and non-critical operations. Report all issues of concern to upper management as necessary using company policy and company Ethic procedures. . Handle discipline problems per Department and Company policy. Review all employee performance. Must take an active part in generating departmental cost reduction savings in the area of production and process procedures or any other means. Required to work overtime and hours other than normal shift hours as required by management Requirements for the Production Supervisor Education: Bachelor's Degree in Industrial or Manufacturing Engineering or High School Diploma and 3+ years of supervisory experience in an industrial manufacturing facility Demonstrated ability to identify and implement continuous improvement in all areas of the business. Strong communication skills (verbal, written, oral, listening & approachability). Ability to build constructive and effective relationships throughout the organization. Excellent computer skills (specifically Microsoft Office products). Benefits for the Production Supervisor Excellent benefits. Keywords: lean, 5s, kaizen, six sigma Production Supervisor Job...

Project Manager - Medical Device - Pharma

Our client is adivision of a global Medical Device manufacturer, seeking a ProjectManager who will be responsible for delivery and launch of MedicalDevices to the market. Projects will include enhancements to existingproducts as well as new product launches. The Project Manager will leadthese efforts by leading cross-functional teams and ensuring that eachteam member is completing their assigned tasks in a timely manner toachieve project goals. Responsibilities: Works with cross-functional teams with representatives from R&D, Quality, Marketing, Regulatory Affairs, Packaging, Supply Chain, Operations, Finance and Manufacturing to deliver new products and product enhancements Organizes team activities, including providing detailed minutes of all project meetings, monitoring progress against the project schedule, ensuring that team activities are supported Works closely with Marketing, Clinical Development and Manufacturing functions to ensure understanding of product application and serves as Voice of the Customer when interfacing with project teams and external partners Ensures that projects are managed in accordance with company policy Plans and leads projects, working with engineers and non-technical team members Responsible for conducting project meetings, design reviews, and publishing and following up on action items, and is the driving force to keep the project on schedule Ensures that progress is reported and that all stakeholders are up-to-date on project status Responsible for project budget...

Engineering Technician

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

SALES ENGINEER

Sales Representative Murzan, Inc. is an engineering company that develops and manufactures pumps and process equipment for food, meat & poultry, pharmaceutical, beverage, cosmetic, and biomedical industries located in Norcross GA Seeking for its inside/ outside sales and service department, someone with experience in any of the following industries: food, beverage, poultry, cosmetic, and/or pharmaceutical....

Field Service Engineer I

Danaher Company Description Leica Biosystems (LBS) is a world-leading biomedical business specializing in solutions for histopathology predominantly used for cancer diagnosis and research. Leica Biosystems is part of Leica Microsystems, a wholly owned subsidiary of the Danaher Corporation. The organization has been aggressively investing in Medical Technologies that enhance patient care, treatment and diagnosis. Leica Biosystems was formed following the acquisition of the then listed Vision Systems Ltd. (Melbourne, Australia) and integration with Leica?s own Sectioning and Specimen Processing business. The combined businesses have created the most comprehensive product portfolio for histo-pathology in the market. Leica Biosystems is the only source to offer instruments for the entire histo-pathology process, as well as the Novocastra? range of antibodies and reagents. In the last four years Leica Biosystems has in average, outgrown the market with a strong double digit Core Growth rate. Specifically Leica Biosystems offers Advanced Staining Systems and Reagents as well as Histology Systems and Materials Sectioning products. Leica offers competitive benefits including medical, dental, vision, prescription, long term care, life insurance, STD, LTD and 401 (k). See our website at www.danaherbenefits.com. If you need assistance applying, please contact us at hr.NA@leica-microsystems.com or call 1-800-248-0123. Leica Microsystems Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law. Equal Opportunity Employer: Race, Color, National Origin, Religion, Sex, Disability, Vet, Sexual Orientation, and Gender Identity. Description Provide technical service and support on equipment with in the company, ISO, FDA, and budgetary guidelines with the objectives of minimizing customer downtime and generating revenue opportunities for Leica. RESPONSIBILITIES Provide installation support, maintenance, modification and/or repair on various mechanical, electro-mechanical, electronic and refrigeration instruments. Effectively communicate with internal colleagues and external customers within established time guidelines in order to meet customer's expectations Document and complete service administration activities in a timely manner in order to comply with ISO, FDA, and Leica policies. Actively support the sale of service contracts, assist sales representatives and service engineers with system configurations and upgrades, and provide input on ways to improve financial performance in order to generate service revenue. Broaden knowledge and experience to improve product, application and professional development skills and ultimately, represent the company in a professional manner. Maintain spare parts stock within budgetary limits in order to maximize "Fast Time Fix" repair metrics. Control expenses in order to maximize the profit contribution to the company. Represent the company in a professional manner in order to install confidence within current and prospective customers of Leica SP products. Reports to Regional Service Manager Travel: 70-90% Frequent overnight travel, often with short notice. Occasional international travel may be required. Must have a valid driver's license with no moving violations PHYSICAL REQUIREMENT : Must be able to lift up to 25 pounds (2/3rd of the time; and up to 100 pounds (1/3 of the time). Candidate/Employee must be able to meet/pass all applicable Vendor Credentialing requirements for their applicable role as deemed necessary by Leica. These requirements are subject to change depending on territory, industry/customer demand, and company policy. Equal Opportunity Employer: Race, Color, National Origin, Religion, Sex, Disability, Vet, Sexual Orientation, and Gender Identity....

Research Engineer

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

Engineer - Jr

Responsibilities: Operations Engineer will work on a cross-functional team that supports the manufacture of orthopedic implants by being a designated owner for nonconformance?s through their life-cycle, as part of the high-performing Rapid Improvement Team. The team is responsible to: identify and drive organizational compliance of nonconformance?s to mitigate their impact on our internal and external customers, and continuously pursue plant-wide solutions to reduce identifiable nonconformance trends. Specific responsibilities of the Operations Engineer include, but are not limited to, the following: ?Be an active member within the Team to process nonconformances (NC) through the nonconformance process, with a direct overall responsibility of the lead-time to assess the NC for the product risk and compliance risk ?Will be the owner of assigned nonconformances through the entire NC life-cycle, from identifying scope, documenting detailed descriptions, and through NC closure. ?Understand and interpret internal quality system requirements and external regulations to identify potential NCs. ?Be able to read and interpret product print requirements. Apply knowledge of Geometric Dimensioning and Tolerancing (GD&T) to identify product impact due to gauge design/calibration errors. ?Effectively liaise with various cross-functional teams such as the Manufacturing value-streams, R&D, Regulatory/Compliance, Material Science, Supplier and Supplier quality, etc to scope and process NCs ?Responsible to generate reports from multiple systems to create robust NCs. ?Direct responsibility to escalate issues to leadership that can potentially impact organizational performance. ?Work with the business to recommend and document robust Correction plans. Assist and communicate the value-streams responsibilities for the corrections. ?Participate and lead continuous improvement (kaizen) activities (when needed) to improve the overall performance of the NC system, such as value stream mapping, cycle time studies, suggesting mistake-proofing activities, etc. ?Participate and lead in kaizen activities that identify trends based on nonconformance?s, and implement plant-wide improvements to reduce those trends. Qualifications and Work Experience: ?A Bachelors of Science Degree in Engineering (prefer Mechanical, Industrial, Biomedical, Biomechanical) is required for this role. Ideal candidates will also possess the following skills/experiences: ?2+ years professional experience in a production/manufacturing environment within a medical device industry ?Demonstrate and apply critical thinking and a compliance oriented mindset. ?Demonstrate the ability to investigate issues and drive resolution to address potential nonconformance?s. ?Demonstrated computer skills using Microsoft Office applications (Word, Excel, PowerPoint, etc). ?Knowledge of QMS systems, ERP system would be highly desired.(Windchill and Oracle preferred) ?Ability to draft records in a lucid and logical flow using technical language. ?Technical writing would be a highly desired skill. ?Demonstrated ability to prioritize and accomplish work with little supervision (self-starter) ?Demonstrated ability to perform in and be challenged by a team-based environment, which places a high degree of emphasis on accountability....

Mechanical Engineering and Medical Device Researcher

Come join our stable contract for an exciting carrier in Electronic Database Searching! ASRC Federal Space and Defense brings a 14-year history of delivering high-performance space systems engineering, integration and satellite operations services to civil and defense agencies. ASRC Federal Space and Defense provides these services throughout all phases of the program life cycle. We are seeking an Electronic Database Searcher with a strong Engineering or Medical Device background to join our stable contract in Alexandria, VA. Role/Responsibilities: The responsibilities of this position include, but are not limited, to the following: ? Performs detailed biotechnology or mechanical technology related literature searching in various online databases. ? Analyzes search requests in the areas of mechanical engineering and manufacturing and medical devices and processes to determine requirements and strategy, and develops and modifies complex search strategies to conduct searches of electronic resources. ? Reviews and prepares search results for customer in specified formats. ? Uses independent judgment in selecting from a wide variety of electronic databases. ? Fluently uses search tools offered by a number of vendors as well as in house systems to develop complex search strategies and conduct the searches. ? Responds to requests requiring difficult and comprehensive searches for information through the use of primary and secondary sources, both current and retrospective, ephemeral materials, and/or information not readily available in published form. ? Identifies, examines, and evaluates major publications and tools in scientific and technical areas covered by the Electronic Information Center to which they are assigned. ? The incumbent prepares and delivers oral and written presentations and training to patent examiners and special groups concerning the services of the information center and the use of information sources and search tools. ? Acts as a backup for reference staff in provision of reference assistance. Education and Experience Requirements: ? Four year degree in Biomedical Engineering or Mechanical Engineering. ? Four years of experience in electronic database searching. ? Expert in complex searching of scientific and technical literature using one or more major on-line commercial vendors (Proquest Dialog or STN experience preferred). ? Knowledge of the U.S. patent system, examining procedures, and U.S. as well as foreign patent formats a plus. ? Expert knowledge of scientific and technical literature, reference tools, and on-line systems. ? Expert in searching for scientific and technical literature in at least one technology area and experience in searching one or more other technology areas as identified in Task Order 1 ? Electronic Information Center Support. ? Expert in searching for literature and resources on the Internet. ? Must possess both excellent interpersonal and customer service skills. ? Must have strong communication skills. ? Must be able to work in a demanding production oriented environment. ASRC Federal and its Subsidiaries are Equal Opportunity / Affirmative Action employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status....

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