Staff R&D Engineer — Global MedTech Sustaining

BD; Chicago (IL); Sur place; USD 136 000 - 217 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k) plan

Dental coverage

Résumé du poste

BD's Staff R&D Engineer role drives lifecycle management for globally released medical devices. You will lead sustaining engineering projects, evaluate designs against evolving clinical and regulatory needs, and develop practical, compliant solutions to ensure product continuity and market access.

Collaborating with R&D, Quality, Regulatory Affairs, Operations, Manufacturing, and Marketing, you will apply design controls, risk management, and human factors to changes, mentor others, and

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, or related technical discipline with 8+ years of relevant 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.

Responsabilités

• Lead sustaining engineering projects for global product portfolios.
• Evaluate designs against evolving clinical, regulatory, and business requirements.
• Develop solutions for global registrations, market expansion, and compliance.
• Mentor and provide technical expertise across the org.

Connaissances

Design controls knowledge

Regulatory understanding

Risk management

Cross-functional collaboration

Analytical thinking

Formation

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or Systems Engineering

8+ years medical device experience

Outils

Minitab

Description du poste

BD's Staff R&D Engineer role drives lifecycle management for globally released medical devices. You will lead sustaining engineering projects, evaluate designs against evolving clinical and regulatory needs, and develop practical, compliant solutions to ensure product continuity and market access.

Collaborating with R&D, Quality, Regulatory Affairs, Operations, Manufacturing, and Marketing, you will apply design controls, risk management, and human factors to changes, mentor others, and