Staff Engineer

Becton Dickinson seeks a Staff R&D Engineer to lead sustaining engineering initiatives for globally commercialized medical devices. The role involves evaluating product designs, developing technical solutions for compliance and market expansion, and collaborating across cross-functional teams to support long-term portfolio success.

Responsibilities

• Lead sustaining engineering projects supporting global product portfolios and design improvements
• Evaluate product designs against clinical, customer, regulatory, and business requirements
• Develop and implement technical solutions for global registrations, compliance, and product enhancements
• Conduct technical assessments for design changes, obsolescence, supplier changes, and risk mitigation
• Support regulatory submissions, technical files, risk analyses, and design documentation

Requirements

• Bachelor's degree in Mechanical, Biomedical, Systems Engineering, or related discipline with 8+ years experience
• Demonstrated experience with commercially released medical device lifecycle management and design changes
• Strong knowledge of Design Controls (21 CFR Part 820, ISO 13485) and Risk Management (ISO 14971)
• Working knowledge of biocompatibility (ISO 10993), clinical considerations, and regulatory requirements
• Experience supporting global regulatory submissions and technical documentation
• Strong analytical, systems-thinking, and cross-functional influence capabilities