Senior Design Assurance Engineer

My client is a growing medical device company at the forefront of laser-based precision technologies that directly improve patient care. They are seeking a Senior Design Assurance Engineer to ensure their products meet regulatory requirements, quality standards, and customer expectations. This hands-on technical leadership role focuses on design controls, risk management, and compliance testing across the product lifecycle. You will partner closely with R&D, Regulatory, and Manufacturing to keep design assurance practices robust, support regulatory submissions, and drive continuous improvement. Lead and conduct design control activities for new product development and sustaining engineering Support risk analysis, including development and maintenance of DFMEAs and PFMEAs Partner with cross-functional teams on design and process validation/verification, including software validation and IQ/OQ/PQ protocols Collaborate with Design Engineering to create and maintain Design History Files and Technical Files Coordinate with third-party test houses to ensure compliance testing is executed and documented properly Assist Regulatory Affairs with FDA, CE, and other global submissions Ensure adherence to applicable regulatory requirements, company policies, and quality standards Bachelor's degree in a scientific or engineering field 8+ years in an engineering or quality role within the medical device industry Strong knowledge of Design Controls and Risk Management, including FDA QSRs, ISO 485, ISO 14971, IEC 60601, IEC 60825, IEC 62366, and IEC 62304 (preferred) Experience supporting compliance testing (EMC, EMI, IEC) with external test houses such as TÜV or Intertek Proven ability to maintain design specifications, V&V protocols, and DFMEA/PFMEA Working knowledge of advanced statistics (hypothesis testing, DOE, ANOVA, R&R, capability analysis, tolerance intervals, power and sample size), with Minitab preferred Lasers and optical technology experience is a plus, but not required #J-18808-Ljbffr Kaye/Bassman International