SRG, the leader in the Life Sciences human capital industry, is looking for a full-time contract Product Development Engineer III to join our client's medical device manufacturing team.

*This is a fully remote position, however the company is located in Mansfield, Ma and being able to come onsite is a plus.

*This is for W2 contracts only.

MUST HAVES:

• Bachelor's in Engineering Degree, Master's preferred
• Minimum 5 years of Med Device Experience preferred
• Minimum 3 years in product development and/or research/development
• Understanding of medical device V&V process and design requirements traceability
• Experience in EUMDR remediation PD work
• Experience in creation of Protocols, Testing and Verification including product usability is required,

JOB RESPONSIBILITIES:

• Understanding of Medical Device-New product development and Sustaining Engineering Process
• Working knowledge of Technical files and Medical Device product development process
• Knowledge of current European Medical Device directives (MDD/MDR) and CE Mark process
• Experience in Remediation of QMS, Tech File, DHF and Risk Management File
• Understanding of Medical regulatory standards is preferred (EU Regulations MDD & MDR)
• Knowledge on Part 820, Part 11, ISO 13485, MDD/IVDD, IEC 60601x, IEC 62304, ISO 14971
• Knowledge in DFMEA, PFMEA, GD&T and Design documentation processes

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.