Design Control Associate
2 weeks ago
Key Skills: Design controls, PLM
Roles and Responsibilities:
- Plan and execute the migration of Design History Files from the current systems to Teamcenter PLM.
- Develop and maintain Design Control and Risk Management documentation in the PLM system.
- Collaborate with cross-functional teams to ensure seamless implementation of Teamcenter PLM into the organization.
- Provide support and/or training to team members on the use of digitized tools and processes.
- Utilize Polarion requirements management tools to manage and track requirements.
- Ensure compliance with Design Control regulations and standards for medical devices.
- Identify and implement process improvements to enhance efficiency and compliance.
Skills Required:
- Experience with Design Control and Risk Management in medical devices
- Hands-on proficiency with Teamcenter PLM or similar PLM tools
- Familiarity with Polarion or other requirements management tools
- Understanding of DHF (Design History File) management and documentation
- Knowledge of regulatory standards related to medical device design control
- Ability to work cross-functionally and support tool implementation/training
- Strong documentation and process improvement skills
Education: Bachelor's degree in engineering or a related field.
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