Staff R&D Engineer — Medical Devices, Sustaining (Global)

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

Benefits offered by this job

BD 401(k) Plan

Health insurance

Dental and Vision coverage

Job summary

BD is seeking a Staff R&D Engineer to act as a technical leader within Sustaining Engineering, overseeing lifecycle management for globally released medical devices. You will assess designs against clinical needs, regulatory expectations, and business objectives, delivering practical, risk-based solutions that ensure continuity, registrations, and portfolio success.

You will collaborate with R&D, Quality, Regulatory Affairs, Operations, Manufacturing, and Marketing to drive design improvements,

Qualifications

• Bachelor's degree in a technical discipline with 8+ years of relevant experience or medical device industry experience.
• Strong knowledge of Design Controls (21 CFR Part 820, ISO 13485) and Risk Management (ISO 14971).
• Experience supporting global regulatory submissions and technical documentation.
• Ability to perform complex technical evaluations and develop compliant engineering solutions.

Responsibilities

• Lead or serve as the technical lead for sustaining engineering projects across global product portfolios.
• Evaluate designs against clinical, customer, regulatory, and business requirements to identify improvements.
• Develop technical solutions supporting registrations, market expansion, and compliance initiatives.
• Lead assessments related to design changes, obsolescence, supplier changes, and manufacturing improvements.
• Apply design control, human factors, usability, and risk management to changes in released products.
• Support regulatory submissions, technical files, risk analyses, and change documentation.
• Leverage post-market feedback to drive continuous product improvement.
• Balance customer needs, patient safety, regulatory requirements, and feasibility in decisions.
• Serve as a technical mentor and SME within the organization.

Skills

Analytical skills

Systems thinking

Communication skills

Cross-functional leadership

Regulatory awareness

Education

Bachelor's degree in Mechanical/Biomedical/Systems Engineering or related field

Medical device industry experience

Tools

Minitab

Job description

BD is seeking a Staff R&D Engineer to act as a technical leader within Sustaining Engineering, overseeing lifecycle management for globally released medical devices. You will assess designs against clinical needs, regulatory expectations, and business objectives, delivering practical, risk-based solutions that ensure continuity, registrations, and portfolio success.

You will collaborate with R&D, Quality, Regulatory Affairs, Operations, Manufacturing, and Marketing to drive design improvements,