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# Design Assurance Engineer - Marlborough, MA

- **Company:** IPG Photonics Corporation
- **Location:** Marlborough, MA, United States
- **Experience:** Experienced
- **Contract:** Permanent contract
- **Skills:** Microsoft Word, Microsoft Excel, Analysis of Variance (ANOVA), Software Design Documents, Failure Mode Effects Analysis, Statistical Hypothesis Testing, Minitab, Verification and Validation (Software), Iq/oq/pq
- **Published:** August 4, 2026
- **Apply:** https://diversityjobs.com/main/sendform/8/8/28176/1/17849297?backUrl=%2Fcareer%2F17849297%2FMarlborough-Ma-Massachusetts-Marlborough

## About the Role

* Bachelor's Degree in scientific or engineering field; electrical engineering is preferred
 * 3-5 years of experience with engineering and development of Class II electro-mechanical medical devices
 * 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 Excel

## Description

* 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
 * Perform all other essential duties as assigned


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