Mechanical Engineer

We are seeking 1–2 R&D Engineers to support a manufacturing transfer project for orthopedic sports medicine devices. The ideal candidate will have medical device development experience, preferably within orthopedics, and a strong understanding of design transfer, verification/validation, change control, and regulated product development.

This role will work closely with cross-functional partners including Regulatory Affairs, Quality Engineering, Manufacturing, and R&D to develop, coordinate, review, and approve key technical documentation and deliverables.

A particularly important component of the role will be leading Change Control Plans (CCPs) and Change Control Reports (CCRs) and coordinating cross-functional stakeholders to ensure timely alignment and execution.

• 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 and document appropriate design verification/validation rationales as applicable.
• Author and coordinate Change Control Plans (CCPs).
• Author and coordinate Change Control Reports (CCRs).
• Lead cross-functional discussions to align R&D, Quality, Regulatory, Manufacturing, and other stakeholders on change-control activities and deliverables.
• Participate in core project team and sub-team meetings.
• Draft technical strategies, rationales, plans, reports, and other regulated documentation.
• Use the company's document management system to read, review, route, and approve documents.
• Support execution of manufacturing transfer activities in a regulated medical device environment.
• Bonus:
  Conduct and document simulated-use benchtop testing onsite in Raynham, including development/execution of protocols and preparation of test reports.

• Writing and coordinating Change Control Plans and Change Control Reports.
• Participating in project team and cross-functional sub-team meetings.
• Writing technical strategies, rationales, plans, and reports.
• Reviewing, routing, and managing documentation within the applicable document management system.
• Coordinating with cross-functional stakeholders to keep deliverables aligned and on schedule.

• Bachelor's degree in Engineering or a related engineering discipline.
• Experience in R&D engineering within a regulated medical device environment.
• Experience with orthopedic devices strongly preferred.
• Experience with manufacturing transfer/design transfer activities.
• Working knowledge of medical device verification and validation processes and documentation.
• Experience developing or reviewing change controls, technical plans, and reports.
• Experience working cross-functionally with teams such as R&D, Quality Engineering, Regulatory Affairs, and Manufacturing.
• Strong written and verbal communication skills.
• Ability to manage multiple stakeholders and drive technical deliverables to completion.

• Experience with orthopedic sports medicine devices.
• Experience authoring CCPs and CCRs.
• Windchill PLM experience is strongly preferred.
• Experience with another Product Lifecycle Management (PLM) system required.
• Experience with Creo CAD is a plus but not required.
• Experience with simulated-use or benchtop testing.
• Ability and willingness to work onsite in Raynham, MA for testing and project activities.

This position is recruited by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in…