Design Assurance Engineer

Job Function

Conduct product design control activities for new and sustaining product development efforts

Support risk analysis activities, including design and process FMEA

Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities

Support Design Engineering in the creation of Design History and Technical Files

Interact with third-party test houses that conduct compliance testing of IPG products

Assist regulatory department with FDA, CE, and other regulatory submissions

Perform all other essential duties as assigned

Bachelor's degree in scientific or engineering field; electrical engineering is preferred

3-5 years of experience with engineering and development of Class II electro-mechanical medical devices

Knowledge of Design Controls and Risk Management practices, regulations and standards, such as FDA QSR's, ISO 13485, ISO 14971, IEC 60601, 60825, 62366, and 62304 is preferred

Supporting medical device compliance testing (e.g. EMC, EMI, IEC) with external test houses, such as TUV an Intertek

Maintenance of technical design documentation, such as design specifications, verification/validation protocols, and DFMEA/PFMEA.

Working knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power and sample size determinations, etc.), including statistical software tools, such as Minitab, is preferred

Experience with lasers and optical technologies desired, but not necessary

Strong working knowledge of Microsoft Word and Excel