Senior Product Manufacturing Specialist
1 week ago
This role is a critical part of a medical device company's product development team, working on an innovative heart support device to stabilize patients in acute heart failure or undergoing high-risk coronary procedures.
Responsibilities:- Develop and refine manufacturing processes, materials, and methods as part of the product development team.
- Design, specify, procure, and qualify process fixtures and equipment.
- Develop Work Instructions and other supporting documentation for manufacturing processes.
- Execute process characterization and validation activities.
- Become a technical expert in assembly and manufacture of products.
- Maintain quality standards by ensuring compliance with quality requirements throughout all aspects of work.
- Collaborate with internal cross-functional teams and contract manufacturers to ensure system design meets design input.
- Evaluate process and manufacturing technologies and identify opportunities to implement them.
- Develop and execute project plans, tasks, and deliverables.
- A minimum of three years' experience in medical device development.
- A primary or master's degree in an engineering discipline such as polymer, mechanical, manufacturing, or biomedical engineering.
- Experience in fabrication and manufacture of catheter-based medical devices.
- Strong product and process development skills in medical devices.
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Manufacturing Process Specialist
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