23 days old

Mechanical Medical Device Engineer

Kelly Services
Raynham, MA 02767
_Kelly Outsourcing & Consulting Group (KellyOCG), a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a_ **_Sr._** **_Mechanical Engineer_** _for a long-term engagement at one of our Global clients in_ **_Raynham, MA_** _._

_This role is a full-time, fully benefitted position. As a KellyOCG employee 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. All KellyOCG employees receive annual performance reviews._

**_Sr. Mechanical 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):_

+ _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._


+ **_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._**

+ _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 7 years of work experience in the Medical Device industry is preferred_** _. Bilingual English / Spanish desired_

+ **_Experience with DHF files is required._** **_Also experience with Global Transfers is required._**

+ _Experience working around or with_ **_clean room assembly experience with Orthopdics Electrical or electromechanical experience desired._**

+ **_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._

**_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/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. 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: 2021-03-19 Expires: 2021-04-19

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Mechanical Medical Device Engineer

Kelly Services
Raynham, MA 02767

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