Responsible for contributing to the design, development and management of projects for new and legacy products, with a focus on Design Assurance activities of medical laser products. 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. 3-5 years of experience with engineering and development of Class II electro-mechanical medical devices. Plastic Injection mold and Laser experience.
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 ExcelBachelor's Degree in scientific or engineering field; electrical engineering is preferred. US Citizen/Green Card.