Research And Development Engineer in Somerville

Job Description

Job Summary:

R&D Project Engineer (Remote)

Experience in medical device R&D, regulatory, or quality roles

Experience in Adaptiv is highly

Proven experience leading cross‑functional projects

Hands-on experience with EU MDR requirements

Exposure to EUDAMED submissions or data preparation is highly

Key Responsibilities:

• Provide R&D LCM support to the MDR franchise initiative to successfully close applicable Design History Files (DHF) leading to the implementation of MDR compliant product families in the applicable manufacturing sites.

• Provide R&D LCM support in the manual data collection for EUDAMED UDI per approved protocol and work with cross functional team for all Product families as required.

• Engage with the cross-functional team members as required to ensure proper documentation is developed and approved in the PLM system as well as escalation of any concerns, issues or delays to management.

• Ensure to complete all required assigned training courses on time.

MUST Have skills:

EU MDR 2017/745

PLM- Engineering Change Management

Cross Functional support

Design History File (DHF)

Design Control