Sr Design Assurance Engineer

Job Summary

The Senior Design Assurance Engineer plays a critical role in ensuring that IPG’s medical device products meet regulatory requirements, quality standards, and customer expectations. This position provides technical expertise and leadership in design controls, risk management, and compliance testing throughout the product lifecycle. The Senior Design Assurance Engineer partners closely with cross‑functional teams—including R&D, Regulatory, and Manufacturing—to maintain robust design assurance practices, support regulatory submissions, and drive continuous improvement.

This role requires deep knowledge of medical device regulations and standards, strong analytical skills, and the ability to balance technical detail with strategic quality objectives.

• Lead and conduct product design control activities for both new product development and sustaining engineering projects.
• Support risk analysis activities, including development and maintenance of design and process FMEAs.
• Partner with cross‑functional teams to support design and process validation/verification activities, 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 for IPG products is properly executed and documented.
• Assist the Regulatory Affairs department in preparing FDA, CE, and other global regulatory submissions.
• Ensure adherence to applicable regulatory requirements, company policies, and quality standards.
• Perform other essential duties as assigned to support departmental and organizational objectives.

• Bachelor’s Degree in a scientific or engineering field is required.
• Minimum of 8 years of experience in an engineering or quality role within the medical device industry.
• Strong knowledge of Design Controls and Risk Management practices, regulations, and standards such as FDA QSRs, ISO 13485, ISO 14971, IEC 60601, IEC 60825, IEC 62366, and IEC 62304 (preferred).
• Experience supporting medical device compliance testing (e.g., EMC, EMI, IEC) with external test houses such as TÜV or Intertek.
• Proven ability to maintain technical design documentation, including design specifications, verification/validation protocols, and DFMEA/PFMEA.
• Working knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability analysis, tolerance interval analysis, power and sample size determinations) with proficiency in statistical software tools such as Minitab (preferred).
• Experience with lasers and optical technologies is desirable, but not required.