Senior Compliance Engineer - Marlborough, United States - IPG Photonics

Description

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

• Monitor the status of relevant international standards, and provide guidance on present and future regulatory testing requirements.
• Support pre-compliance testing and mitigation of new and modified designs.
• Interact with third-party test houses that conduct compliance testing of IPG products. This includes creation of EMC test plans, checklists, documentation packages, on site test support, test report reviews
• Support risk analysis activities, including risk management plans, haard analysis, FMEA, and risk managements reports
• Assist regulatory department with FDA, CE, and other regulatory submissions
• Perform all other essential duties as assigned

Requirements

• 10+ years of experience with development and compliance testing of Class II electro-mechanical medical devices
• Knowledge of standards and regulations such as ISO 14971, IEC , , , , , 62366, 62304, ETSI EN , 21 CFR ,
• Knowledge of Design Controls, regulations and standards such as FDA QSR's, and ISO 13485 is preferred
• Knowledge of EMC/EMI mitigation techniques is preferred
• Supporting medical device compliance testing (e.g. EMC, EMI, and Safety) with external test houses, such as TUV and Intertek. Including EMC Test Plans, Safety Checklists, and documentation packages
• Knowledge of technical design and risk management documentation, such as design specifications, verification/validation protocols, risk management plans, hazard analysis, FMEA, and risk management reports
• Experience with lasers and optical technologies desired, but not necessary
• Strong working knowledge of Microsoft Word and Excel

Education Required

• Bachelor's Degree in scientific or engineering field; electrical engineering is preferred

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

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