R&D Engineer, Medical Devices (Orthopedics & Change Control)

Mykelly; Raynham (MA); Hybrid; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Kelly Services is seeking 1–2 R&D Engineers to support a manufacturing transfer project for orthopedic sports medicine devices. The role focuses on CCPs/CCRs, design transfer, and cross-functional collaboration with Regulatory Affairs, Quality, and Manufacturing.

Work is onsite in Raynham, MA with a potential hybrid arrangement. Candidates should have medical device development experience and strong documentation skills for regulated product development.

Qualifikationen

• Bachelor's degree in Engineering or related field required.
• Experience in medical device development or regulated environment preferred.
• Strong written and verbal communication skills.
• Experience with design transfer, verification/validation, change control.

Aufgaben

• Author transfer plans and technical documentation for manufacturing transfer.
• Develop and document V&V strategies for devices.
• Prepare product stability / shelf-life strategies and documentation.
• Coordinate CCPs/CCRs and lead cross-functional discussions on changes.
• Draft technical strategies, rationales, plans, and reports.
• Ensure documents read, routed, and approved in the DMS system.

Kenntnisse

Communication skills

Cross-functional collaboration

Documentation

Ausbildung

Bachelor's degree in Engineering

Tools

Windchill PLM

Creo CAD

PLM systems

Jobbeschreibung

Kelly Services is seeking 1–2 R&D Engineers to support a manufacturing transfer project for orthopedic sports medicine devices. The role focuses on CCPs/CCRs, design transfer, and cross-functional collaboration with Regulatory Affairs, Quality, and Manufacturing.

Work is onsite in Raynham, MA with a potential hybrid arrangement. Candidates should have medical device development experience and strong documentation skills for regulated product development.