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1+ months

Sr Mechanical Biomendical Engineer

Kelly Services
Raynham, MA 02767
_Kelly Engineering is currently seeking a_ **_Mechanical Biomedical Engineer_** _for a long-term engagement at one of our Global clients in_ **_Raynham, MA_** _. This role is a full-time, fully benefitted position._


_Remote with travel to Raynham, MA with possibility to make the move full time down the road._


_You will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. Youll also be eligible for paid time off, including holiday, vacation and sick/personal time._


**_Mechanical Biomedical Engineer_** _ should excel in a medical device environment that embraces teamwork, change, risk-based decision-making and flexibility._


_This individual will work in a team setting to provide leadership and support throughout the product lifecycle. This individual should be willing to make a significant contribution to a multi-disciplinary team, must be self-motivated and have excellent written and verbal communication skills. Working in a team setting, this individuals major responsibilities will be as follows (but not limited to):_


+ _Senior level,_ **_for Manufacturing Transfer R&D support position_** **_(Europe site going to Mexico Site)._**

+ _Will be remediating input/output matrices and identifying and coordinating testing program (tests to validate the manufacture of devices in new location)._

+ _Looking for a special, well rounded person here._

+ _While not looking for a manager, some management exp._

+ _Would be a plus as this project will involve lots of people and personalities._

+ _Support legacy products and design through design control activities._

+ _Learn surgical procedures and map the product solutions into potential areas of risk and liability._

+ _Support and conduct process verification and validation activities._

+ _Conduct and lead process/design/procedural failure mode effects and analysis._

+ _Develop risk assessment, inspection methodology and acceptance criteria for inspection sample plans and conduct audits of new suppliers as part of the project teams._

+ _Conduct audits of new suppliers as part of the new product development project teams_

+ _Support maintenance of existing products including but not limited to design changes, process changes, supplier changes, remediation, recertification and brand extensions._

+ _Experience with Corrective & Preventive Actions, Nonconforming Materials, Risk Management, etc._

+ **_Provides leadership in the understanding of Medical Device (21 CFR 820) regulations to other disciplines._**

+ _Communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing._


**_Qualifications_**


+ **_A minimum of a Bachelor's degree in a Scientific discipline is required. (Mechanical or Biomedical degree/experience)_** _An advanced degree in a related field is an asset._

+ _Familiarity with clean room assembly desired._

+ _Spanish and/or French fluency a nice to have._

+ _Prior R&D document remediation and Product transfer experience highly desirable._

+ _Excellent problem solving and decision-making skills will be required. Interpersonal skills that foster conflict resolution as it relates to technical situations will be required._

+ **_A minimum of 4-6 years of work experience in the Medical Device industry._**

+ _Experience with DHF files is required. Also experience with Global Transfers is required_

+ _Advanced Technical Training in Quality Engineering principles, Risk Management, Product Testing, and Sports Medicine is preferred._

+ _Knowledge of ISO 13485, ISO 14971, 21 CFR Part 820, and any other specific product standard is an asset._

+ _Experience conducting Process / Design Failure Mode Effects and Analysis is required._

+ _Experience leading Process Verification / Validation activities is required._

+ _Experience with Blueprint reading/literacy including GD&T is preferred. Familiarity with inspection methods and techniques is an asset._

+ _Process Excellence/Lean experience is preferred._

+ _This position will be based in Raynham, MA hopefully soon._


**_Important information:_** _This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States immediately and without employer sponsorship._


_(_ **_F1 OPT/H1B_** _cannot be considered for this position)._


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2021-05-14 Expires: 2021-07-15

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Sr Mechanical Biomendical Engineer

Kelly Services
Raynham, MA 02767

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