Design Assurance Engineer

Job Description

IPG Medical, a wholly owned subsidiary ofIPG Photonics (NASDAQ: IPGP), is focused on developing next-generation products based on IPG Medical's state-of-the-art laser 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 toattractingand 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 ideal candidate is a diligent, hardworking individual who is willing and able to learn new skills and technologies to ensure the IPG Medical team achieves its mission.

Job Function

• 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

Requirements

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 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

This position must meet Export Control compliance requirements, therefore a "US Person" as defined by 22C.F.R. §120.15 are required. "US Person" includes US Citizen, lawful permanent resident, refugee, asylee. License exception Technology and software under restriction (TSR) defined in 15 CFR 740.6 may permit person from Country Group B. The following link will take you to the government site with the list of Country Group B:https://www.bis.doc.gov/index.php/documents/regulation-docs/452-supplement-no-1-to-part-740-country-groups/file

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