The hiring manager emphasized that technical skills alone are not enough. Candidates must demonstrate they can operate autonomously, navigate ambiguity, and proactively drive a complex manufacturing transfer project without constant direction. Windchill + manufacturing transfer + medical device experience will likely get immediate attention.

3-5 Must-Haves

• Medical device industry experience, preferably supporting mechanical medical devices
• Strong background in R&D Engineering within a regulated product environment
• Experience with manufacturing transfers/site transfers (ideal if supporting product movement between facilities)
• Knowledge of design controls, change management, engineering documentation, and validation activities
• Proven ability to work independently, drive projects forward, influence stakeholders, and operate with minimal supervision

Preferred Skills

• Windchill PLM experience (home-run candidate)
• Experience with other PLM/document control systems
• FDA and/or regulated medical device environment experience
• Experience creating technical reports, project plans, validation documentation, CCR/CCP-related documentation
• Experience partnering with Quality, Regulatory Affairs, Manufacturing, and Operations teams