Staff R&D Engineer – MedTech Sustaining & Global

BD; Atlanta (GA); On-site; USD 136,000 - 217,000; Full time

Benefits offered by this job

BD 401(k) Plan

Paid time off

Job summary

BD in Franklin Lakes, NJ seeks a Staff R&D Engineer to lead sustaining engineering for global medical devices. You will evaluate designs against clinical, regulatory, and business needs and develop compliant solutions across the product lifecycle.

You will collaborate with R&D, Quality, Regulatory, Operations and Marketing to drive improvements, support regulatory submissions, and mentor teams. The role requires a Bachelor's in engineering and 8+ years' experience; on-site presence is expected.

Qualifications

• 8+ years of relevant experience, or equivalent medical device industry experience.
• Strong knowledge of Design Controls (21 CFR Part 820, ISO 13485) and ISO 14971 risk management.
• Biocompatibility awareness (ISO 10993) and regulatory impact on design.
• Experience with global regulatory submissions, registrations, and technical documentation.
• Ability to perform complex technical evaluations and suggest compliant solutions.

Responsibilities

• Lead or act as technical lead for sustaining engineering projects across global product portfolios.
• Evaluate designs against clinical, regulatory, customer, and business requirements and identify improvements.
• Develop technical solutions supporting global registrations, market expansion, and compliance initiatives.
• Lead assessments related to design changes, obsolescence, supplier changes, and manufacturing improvements.
• Apply design controls, human factors, usability, and risk management to released products.
• Support regulatory submissions, technical files, risk analyses, and design change documentation.
• Leverage post‑market feedback and clinical insights to drive product improvements.
• Facilitate cross‑functional decision making and mentor colleagues as SME.

Skills

Analytical thinking

Systems thinking

Communication skills

Cross-functional influence

Education

Bachelor's degree in Mechanical Engineering or Biomedical Engineering

Master's or advanced degree in engineering (preferred)

Medical device industry experience

Tools

Minitab

Job description

BD in Franklin Lakes, NJ seeks a Staff R&D Engineer to lead sustaining engineering for global medical devices. You will evaluate designs against clinical, regulatory, and business needs and develop compliant solutions across the product lifecycle.

You will collaborate with R&D, Quality, Regulatory, Operations and Marketing to drive improvements, support regulatory submissions, and mentor teams. The role requires a Bachelor's in engineering and 8+ years' experience; on-site presence is expected.