IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life.

Our mission is to develop innovative medical device laser solutions that make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged, diverse, and thriving workforce that drives a sustainable future for our company and society.

Working at IPG Medical Group you can expect challenging projects, a motivating and friendly environment, and competitive benefits.

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.

Requirements:

• 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.

Please click on the following link to apply for this position: https://myjobs.adp.com/ipgjobs/cx/job-details?__tx_annotation=false&reqId=5001149914706

Equal Employment Opportunity