Staff R&D Engineer, Medical Devices - Lifecycle Leader

Becton Dickinson; Franklin Lakes (NJ); Vor Ort; USD 136.000 - 217.000; Vollzeit

Benefits dieser Stelle

Medical coverage

Health Savings Accounts

Dental coverage

Vision coverage

Life and AD&D insurance

Zusammenfassung

Becton, Dickinson and Company in the United States is seeking a Staff R&D Engineer within Sustaining Engineering to manage the lifecycle of medical devices. You will collaborate with R&D, Quality, Regulatory Affairs, Operations, Manufacturing, and Marketing to drive design improvements and ensure product continuity.

You will lead technical assessments, support global regulatory submissions, and mentor others while balancing patient safety, regulatory needs, and business objectives.

Qualifikationen

• Bachelor's degree in Mechanical, Biomedical, or Systems Engineering or related field with 8+ years of experience.
• Strong knowledge of design controls (21 CFR Part 820, ISO 13485) and risk management (ISO 14971).
• Experience supporting global regulatory submissions and product registrations.
• Ability to perform complex technical evaluations and provide practical solutions.
• Understanding interactions between design, materials, manufacturing, safety, and regulatory requirements.

Aufgaben

• Lead sustaining engineering projects for global product portfolios.
• Evaluate designs against clinical, regulatory, and business requirements.
• Develop solutions supporting global registrations and market expansion.
• Lead design changes, obsolescence, and supplier changes risk mitigations.
• Apply design controls, usability, and risk management to released products.
• Support regulatory submissions and design documentation.

Kenntnisse

Analytical thinking

Cross-functional collaboration

Technical communication

Risk assessment

Ausbildung

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

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

Tools

Minitab

Jobbeschreibung

Becton, Dickinson and Company in the United States is seeking a Staff R&D Engineer within Sustaining Engineering to manage the lifecycle of medical devices. You will collaborate with R&D, Quality, Regulatory Affairs, Operations, Manufacturing, and Marketing to drive design improvements and ensure product continuity.

You will lead technical assessments, support global regulatory submissions, and mentor others while balancing patient safety, regulatory needs, and business objectives.