Manufacturing Engineer III
About The Position
At Gentherm, we believe the next big breakthrough begins with you. As a global leader in thermal management and pneumatic comfort technologies, we develop advanced systems that deliver meaningful solutions to enhance health, wellness, comfort, and efficiency in everyday life. Our products and innovations are created for you, by you. Be part of our team where a human-centric mindset drives everything we do—from the technologies we build to the careers we support. With decades of expertise, we have pioneered advanced solutions that have become a standard expectation for consumers around the world. The same thoughtful approach we take in developing our technologies guides how we support your career: purposeful, impactful, and tailored to you. Because when you thrive, innovation thrives.
Requirements
- Master’s in Manufacturing or Industrial Engineering or closely-related field
- 2 years experience using Microsoft Project and/or Excel to track engineering project tasks, deliverables and milestones
- Designing & developing medical devices within cGMP & regulatory standards
- Maintaining & revising DHR and DHF documents
- Applying GD&T to product designs
- Reading engineering drawings & prints
- Working with heat transfer properties & thermal management systems
- Using Visual CRM software
- Working with third-party test agencies
- Supporting external regulatory audits
- Performing engineering change control
- Performing root cause analysis & engineering change control
- Performing medical device process validation, including installation, operational & performance qualification, in alignment with ISO 13485 standards
Responsibilities
- Lead provision of engineering support for new product development projects
- Coordinate & prioritize engineering tasks and milestones
- Lead process validations
- Manage large-scale legacy projects from initiation to implementation
- Prepare design requirements
- Execute product transfers
- Support engineering evaluation & analysis of product quality issues
- Assure engineering changes & product designs adhere to applicable regulatory, safety & design standards
- Create & maintain product engineering documentation
- Lead execution of product & process improvements
- Serve as subject matter expert for change control & product design and development processes
- Mentor & train junior engineers
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What This Job Offers
Job Type
Full-time
Career Level
Senior
