Senior Hardware Compliance Engineer

Senior Hardware Compliance Engineer responsible for driving electromagnetic compatibility and wireless compliance activities for medical devices. The role involves managing regulatory certification processes, conducting compliance testing, and coordinating with test laboratories and regulatory agencies across multiple global markets.

Responsibilities

• Drive EMC/wireless compliance and certification activities for new and existing medical device products
• Define test plans, conduct compliance testing, and resolve mechanical, EMI, and safety issues
• Coordinate with test laboratories and regulatory bodies on product certification and approvals
• Prepare and submit technical documentation to regulatory agencies (FCC, CE, MIC, etc.)
• Maintain compliance records and provide technical support during post-market audits and inspections

Requirements

• Associate's or Bachelor's degree in electronics, mechanical, or biomedical engineering
• 8+ years experience with accredited EMC/wireless test house on medical and non-medical device projects
• Demonstrated knowledge of EN60601-1 and EN60601-1-2 safety and EMC standards
• Ability to read and interpret electronic schematics
• Strong troubleshooting skills to component level
• Experience with UL, CSA, and IEC product safety approval processes
• Proficiency with computers, electronics, and servo-mechanical devices