Medical Device R&D Engineer: Change Control & Transfer

Kelly; Raynham (MA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Vacation and sick pay

Paid holidays

401(k) plan

Group medical, vision, dental, life, &

Short-term disability insurance

Kelly Discounts on goods and services

Kelly Learning Center offers free

Job summary

Kelly is seeking 1–2 R&D Engineers to support a manufacturing transfer project for orthopedic sports medicine devices. The role requires medical device development experience, preferably in orthopedics, and a strong understanding of design transfer, V&V, change control, and regulated product development.

You will work with Regulatory Affairs, Quality Engineering, Manufacturing, and R&D to develop and approve key documentation, lead CCPs and CCRs, and coordinate stakeholders to ensure timely

Qualifications

• Bachelor's degree in Engineering or related field.
• Experience in R&D engineering within a regulated medical device environment.
• Experience with orthopedic devices and manufacturing/design transfer.

Responsibilities

• Author Manufacturing Transfer Plans and supporting technical documentation.
• Develop and author Verification and Validation (V&V) strategies.
• Develop and author product and packaging stability / shelf-life strategies.
• Update and maintain Requirements and Traceability Matrices.
• Review and approve Process Verification and Process Validation documentation.
• Develop design verification/validation rationales as applicable.
• Author and coordinate CCPs and CCRs.
• Lead cross-functional discussions to align stakeholders on change-control activities.
• Participate in core project team and sub-team meetings.
• Draft technical strategies, rationales, plans, reports, and other regulated documentation.

Skills

R&D engineering

Regulated medical device

Change control

V&V processes

Cross-functional teamwork

Documentation

Education

Bachelor's degree in Engineering

Tools

Windchill PLM

Creo CAD

PLM system

Job description

Kelly is seeking 1–2 R&D Engineers to support a manufacturing transfer project for orthopedic sports medicine devices. The role requires medical device development experience, preferably in orthopedics, and a strong understanding of design transfer, V&V, change control, and regulated product development.

You will work with Regulatory Affairs, Quality Engineering, Manufacturing, and R&D to develop and approve key documentation, lead CCPs and CCRs, and coordinate stakeholders to ensure timely