Senior Compliance Engineer – Medical Device

Onsite Position Located in MA

The Senior Compliance Engineer will ensure products comply with standards and regulatory requirements (Safety, EMC, EMI) in worldwide markets.

Responsibilities:

• 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. This includes the creation of EMC test plans, checklists, documentation packages, on-site test support, test report reviews.
• Support risk analysis activities, including risk management plans, hazard analysis, FMEA, and risk management reports.
• Assist regulatory department with FDA, CE, and other regulatory submissions.

Requirements:

• Bachelor’s Degree in scientific or engineering field; electrical engineering is preferred.
• 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 60601-1, 60601-1-2, 60601-1-6, 60601-2-22, 60825-1, 62366, 62304, ETSI EN 301 489, 21 CFR 1040.10, 1040.11
• 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, including design specifications, verification/validation protocols, risk management plans, hazard analysis, FMEA, and risk management reports.
• Demonstrated capability to work on multiple programs on cross-functional program teams and be an expert relative to product standards and regulatory requirements.
• Experience with lasers and optical technologies is preferred but not necessary.
• Strong working knowledge of Microsoft Word and Excel.

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