R&D Engineer, Medical Devices — Manufacturing Transfer

Intellectt INC; Massachusetts; Hybrid; USD 61,000 - 66,000; Full time

Benefits offered by this job

Contract position; no employer-providd

Job summary

Intellectt INC is seeking an experienced R&D Engineer to support a manufacturing transfer project for orthopedic sports medicine devices in Raynham, MA. The role focuses on CCP/CCR leadership, V&V planning, and collaboration with regulatory, quality, and manufacturing teams.

The contract position emphasizes documentation management, PLM usage, and benchtop testing as needed. Onsite work in Raynham is possible with hybrid arrangement.

Qualifications

• BS degree in Engineering.
• 5+ years medical device product development experience.
• Experience with CCP/CCR and leading cross-functional teams.
• Windchill PLM experience.
• Proficient in MS Office.
• Familiarity with Creo CAD.

Responsibilities

• Author and drive Change Control Plans (CCP) and Change Control Reports (CCR); lead cross functional alignment to meet timelines.
• Develop verification and validation (V&V) strategies and rationales, product/package stability strategies, and the Manufacturing Transfer Plan.
• Update requirements and traceability matrices; review and approve process verification and validation activities.
• Use PLM/document management systems to review, route, and manage documents.
• Attend and actively contribute to main team and subteam meetings.
• Support protocol and report generation; if onsite in Raynham, perform benchtop simulated use testing.

Skills

Change Control

Cross-functional collaboration

Documentation

V&V planning

Windchill PLM

Creo CAD

MS Office

Education

BS in Engineering

Tools

Windchill PLM

Creo CAD

MS Office (document mgmt)

Job description

Intellectt INC is seeking an experienced R&D Engineer to support a manufacturing transfer project for orthopedic sports medicine devices in Raynham, MA. The role focuses on CCP/CCR leadership, V&V planning, and collaboration with regulatory, quality, and manufacturing teams.

The contract position emphasizes documentation management, PLM usage, and benchtop testing as needed. Onsite work in Raynham is possible with hybrid arrangement.