R&D Engineer, Orthopedic Medical Devices | Hybrid (MA)

Kelly Services; Raynham (MA); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

401(k) plan

Paid time off

Annual performance reviews

Kelly discounts

Job summary

Kelly Services is seeking 1-2 R&D Engineers to support a manufacturing transfer project for orthopedic sports medicine devices in Raynham, MA. The role involves design transfer, V&V, change control, and regulated product development, with cross-functional collaboration across Regulatory Affairs, Quality, Manufacturing, and R&D.

Responsibilities include preparing CCPs/CCRs, creating technical strategies and documentation, and leading cross-functional teamwork to ensure timely delivery.

Qualifications

• Bachelor's degree in Engineering or related field.
• Experience in medical device R&D within regulated environments.
• Experience with orthopedic devices preferred.
• Experience with manufacturing transfer/design transfer activities.
• Knowledge of V&V processes and documentation.
• Ability to coordinate cross-functional teams.

Responsibilities

• Author Manufacturing Transfer Plans and technical documentation.
• Develop V&V strategies and documentation.
• Develop stability/shelf-life strategies for products and packaging.
• Maintain Requirements and Traceability Matrices.
• Review and approve Process Verification/Process Validation docs.
• Lead CCPs and CCRs and coordinate cross-functional stakeholders.
• Draft technical strategies, rationales, plans, and reports.
• Use document management system to route/approve documents.

Skills

Engineering degree

Medical device development

R&D engineering

Orthopedic devices

Design transfer

Verification & Validation

Change controls

Cross-functional collaboration

Communication skills

Stakeholder management

Education

Bachelor's degree in Engineering

Tools

Windchill PLM

PLM systems

Creo CAD

Job description

Kelly Services is seeking 1-2 R&D Engineers to support a manufacturing transfer project for orthopedic sports medicine devices in Raynham, MA. The role involves design transfer, V&V, change control, and regulated product development, with cross-functional collaboration across Regulatory Affairs, Quality, Manufacturing, and R&D.

Responsibilities include preparing CCPs/CCRs, creating technical strategies and documentation, and leading cross-functional teamwork to ensure timely delivery.