Sr Design Assurance Engineer - Marlborough, MA

Job Description

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.

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 TUV 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.

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225 Cedar Hill Road, Marlborough, Massachusetts 01752, United States

Exempt

MA: $112,436 – $148,978

The pay range on this posting applies to the role in the primary location specified. If the candidate would ultimately work outside of the primary location posted, the applicable range could differ. Actual starting pay is determined by a number of factors including relevant skills, qualifications, and experience.

• Annual Discretionary Bonus or Sales Bonus as Applicable
• Equity awards as applicable

• Paid vacation time accrued based on years of service
• Paid sick time
• 12 (twelve) Paid Holidays Each Calendar Year

* Prorated for part time schedules

• Medical, dental, and vision insurance plans with options for HSA/FSA
• Dependent Care FSA
• Paid Basic Life and AD&D Insurance
• Short‑term and Long‑term Disability insurance
• 401(k) plan with Company matching
• Employee Stock Purchase Plan (ESPP)
• Tuition Reimbursement Program
• Employee Assistance Program (EAP)
• Adoption Assistance
• Pet Insurance
• Parental Bonding Leave
• Bright Horizons Backup Care
• Bright Horizons College Coach

* Must work at minimum, 20 hours/week.

This job posting will remain active until a candidate is identified and/or the Company rescinds the job posting.

For full consideration, please click on the link to apply.