Job Summary:

Principal Design Quality Engineer (Design History Files) - They will be reviewing the entire catalogue of implantable device DHF's to ensure compliance.

Required Qualifications:

• Bachelor's degree in mechanical engineering, Biomedical Engineering or related Engineering field of study.


• Minimum of 6 years of experience in design assurance, quality, or related medical device or regulated industry experience (Experience with Class III Medical Devices preferred).


• Experience in new product development such as driving and creating risk management deliverables (risk management plan/report, hazard analysis, task analysis, dFMEA, etc.), validating test methods, supporting the creation of design requirements, design verification and validation.


• Experience in developing test methods.


• Gap assessment and remediation.


• Experience with a product develop...