Sr. Staff Systems Engineer

Becton Dickinson seeks a Senior Staff Systems Engineer to lead the architecture and design control of complex electro-mechanical medical devices. The role spans from concept through commercialization, requiring expertise in systems requirements, integration, testing, and regulatory compliance. The successful candidate will mentor cross-functional teams and ensure alignment with user needs, regulatory standards, and business objectives.

Responsibilities

• Lead systems design and architecture development for new and existing medical device products
• Define system requirements, maintain traceability through design and validation phases
• Lead design control activities, technical reviews, and ensure FDA/ISO 13485 compliance
• Plan and execute system integration, testing, and test method development activities
• Lead cross-functional teams on risk management, DFM, and technical problem-solving

Requirements

• Bachelor's in Engineering or Science with 8+ years experience, or Master's with 7+ years, or Ph.D. with 4+ years
• R&D experience with complex electro-mechanical systems or medical devices
• Proficiency with requirements management tools like JAMA, DOORS, or Polarion
• Experience writing system-level requirements and decomposing across hardware, software, mechanical domains
• Strong knowledge of IEC 60601 and medical device regulatory standards
• Systems engineering fundamentals including requirements management, architecture, integration, verification
• Experience writing and executing system verification and validation protocols