Lead Compliance Engineer

The Job

A global leader in advanced medical technology is seeking a Lead Compliance Engineer to drive product compliance strategy across its R&D organization. This high‑visibility, hands‑on role serves as the technical compliance expert—shaping design decisions, guiding cross‑functional teams, overseeing testing, and ensuring complex electromechanical medical products meet global regulatory and safety standards.

What You’ll Do

• Lead compliance strategy for safety, EMC/EMI, wireless, and international certifications.
• Act as the technical SME supporting R&D, Program Management, and Quality/Regulatory teams.
• Participate in design reviews and identify applicable standards.
• Oversee internal and external testing, including EMC, environmental, and IEC 60601‑1.
• Interface with certification bodies (e.g., UL, CSA, TÜV).
• Support compliance for new product development, sustaining engineering, and corrective actions.
• Build compliance plans, verification protocols, certification test plans, and documentation.
• Partner cross‑functionally to integrate compliance into product requirements.
• Lead multiple projects, support CAPA/root cause analysis, and mentor junior engineers.

Physical Requirements

Ability to lift up to 40 lbs and work around mechanical equipment, vibration, and moderate noise.

What You Bring

• Bachelor’s degree required; advanced degree preferred.
• 8+ years in compliance testing and international certifications (less with advanced degrees).
• Strong experience with electromechanical systems, EMC/EMI, wireless technologies, and electrical test equipment (e.g., VNAs, spectrum analyzers).
• Solid understanding of regulated product development and lifecycle processes.
• Proven ability to troubleshoot complex EMC/electromechanical issues.
• Strong communication, analytical thinking, and engineering judgment.
• Familiarity with FDA/ISO/regulatory environments and risk management.
• Python or similar scripting experience is a plus.
• Ability to mentor and develop junior engineering talent.