Medical Device R&D Engineer — Transfer, V&V & Change Control

Intellectt INC; Raynham (MA); Hybrid; USD 59,000 - 63,000; Full time

Job summary

Intellectt INC is seeking an experienced R&D Engineer in hybrid Raynham, MA for a manufacturing transfer project in orthopedic sports devices. The role focuses on CCP/CCR processes, V&V strategies, stability, and traceability.

The position requires 5+ years in medical device R&D, strong transfer and change control expertise, and hands-on Windchill PLM experience to manage documentation across cross-functional teams.

Qualifications

• Bachelor's degree in Engineering.
• 5+ years of medical device product development/R&D experience.
• Strong experience with design transfer and change control.
• Authoring CCPs, CCRs, V&V and stability strategies.
• Experience with requirements management and traceability.
• Hands-on Windchill PLM/document management.
• Strong understanding of technical drawings.
• Strong technical writing and cross-functional communication.
• Ability to independently manage deliverables and timelines.

Responsibilities

• Author and manage Change Control Plans (CCP) and Change Control Reports (CCR).
• Develop V&V strategies and rationales for medical devices.
• Develop product/package stability and shelf-life strategies.
• Develop and support Manufacturing Transfer Plans.
• Update product requirements and traceability matrices.
• Review and approve process verification and validation activities.
• Manage and route technical documentation through Windchill PLM.
• Coordinate with R&D, Quality, Regulatory, and Manufacturing teams.
• Support protocol and report generation.
• Perform benchtop simulated-use testing when onsite.
• Drive cross-functional activities to meet schedules.

Skills

Technical writing

Cross-functional comms

Project management

Detail-oriented

Education

Bachelor's degree in Engineering

Tools

Windchill PLM

Job description

Intellectt INC is seeking an experienced R&D Engineer in hybrid Raynham, MA for a manufacturing transfer project in orthopedic sports devices. The role focuses on CCP/CCR processes, V&V strategies, stability, and traceability.

The position requires 5+ years in medical device R&D, strong transfer and change control expertise, and hands-on Windchill PLM experience to manage documentation across cross-functional teams.