Staff R&D Engineer – Medical Devices Lifecycle

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

Benefits offered by this job

BD 401(k) Plan

Daily Pay

Educational assistance/tuition reimb.

Wellness programs

Job summary

BD is seeking a Staff R&D Engineer in the USA to lead sustaining engineering for medical devices, driving lifecycle management from design changes to global registrations. You will collaborate with R&D, Quality, Regulatory Affairs, Operations, Manufacturing, and Marketing to ensure product continuity and market access.

Bring 8+ years in the medical device field, strong knowledge of Design Controls and ISO 14971, and proven ability to influence cross-functional teams while balancing regulatory,

Qualifications

• Bachelor's degree in Mechanical/Biomedical/Systems Engineering or related (8+ years in medical devices).
• Strong knowledge of Design Controls (21 CFR 820, ISO 13485) and ISO 14971 risk management.
• Experience supporting global regulatory submissions and technical documentation.

Responsibilities

• Lead sustaining engineering projects for global product portfolios.
• Evaluate designs against clinical, regulatory, and business requirements for improvements.
• Develop technical solutions supporting global registrations, market expansion, and compliance.
• Lead design changes, obsolescence, supplier changes, and risk mitigation activities.
• Apply design controls, usability, and risk management to released products.
• Support regulatory submissions, technical files, and risk analyses.
• Use post-market feedback to drive product improvements.
• Balance customer needs with safety, regulatory, and business goals.

Skills

Analytical skills

Systems thinking

Communication skills

Cross-functional leadership

Tradeoff analysis

Education

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

Tools

Minitab

Job description

BD is seeking a Staff R&D Engineer in the USA to lead sustaining engineering for medical devices, driving lifecycle management from design changes to global registrations. You will collaborate with R&D, Quality, Regulatory Affairs, Operations, Manufacturing, and Marketing to ensure product continuity and market access.

Bring 8+ years in the medical device field, strong knowledge of Design Controls and ISO 14971, and proven ability to influence cross-functional teams while balancing regulatory,