Address
Form of workJob Description
Thank you for your interest in positions at IPG Photonics. All Applicants must apply on our company website to be considered. Please visit www.ipgphotonics.com and click on the “Company” tab. We look forward to seeing your application soon!
Job Functions:
Job Functions:
- 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.
Location(s)
- 225 Cedar Hill Road, Marlborough, Massachusetts 01752.
- Employment Type
- Exempt
Education Requirements:
- Bachelor's Degree in scientific or engineering field; electrical engineering is preferred.
Experience Requirements:
- 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 QSRs, 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 and 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 is desired, but not necessary.
- Strong working knowledge of Microsoft Word and Excel.
