Staff R&D Engineer, Medical Devices – Global Lifecycle

BD; Alabama; On-site; USD 136,000 - 217,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

Paid time off

Job summary

BD is seeking a Staff R&D Engineer to lead sustaining engineering for global medical device portfolios. You will collaborate with R&D, Quality, Regulatory Affairs, Operations, Manufacturing, and Marketing to drive design improvements and lifecycle management across products.

The role requires strong analytical and communication skills, plus the ability to influence cross-functional teams while balancing patient safety with business goals. This on-site position is located in Franklin Lakes, USA.

Qualifications

• Requires 8+ years in the medical device industry or equivalent.
• Strong knowledge of Design Controls (21 CFR 820, ISO 13485) and Risk Management (ISO 14971).
• Experience with global regulatory submissions and technical documentation.

Responsibilities

• Lead or serve as technical lead for sustaining projects across global product portfolios.
• Evaluate designs against evolving clinical, customer, regulatory, and business requirements.
• Develop and implement technical solutions to support registrations, market expansion, and compliance.
• Lead assessments related to design changes, obsolescence, supplier changes, and manufacturing improvements.
• Apply design controls, usability, and risk management to changes affecting released products.
• Support regulatory submissions, technical files, and risk analyses.
• Use post-market feedback to drive continuous product improvement.
• Balance customer needs, patient safety, and business objectives in technical decisions.
• Mentor and act as SME within the organization.

Skills

Analytical skills

Communication

Cross-functional collaboration

Decision making

Education

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, or related discipline

Job description

BD is seeking a Staff R&D Engineer to lead sustaining engineering for global medical device portfolios. You will collaborate with R&D, Quality, Regulatory Affairs, Operations, Manufacturing, and Marketing to drive design improvements and lifecycle management across products.

The role requires strong analytical and communication skills, plus the ability to influence cross-functional teams while balancing patient safety with business goals. This on-site position is located in Franklin Lakes, USA.