Manufacturing Engineer, Staff - BAYP4031
$103,900–$173,100 year
On-siteFremont, California, United States
Job Summary
Provide daily engineering support for Nitinol melting, casting, and downstream material processing operations, troubleshooting process, material, and equipment issues to minimize downtime and scrap. Lead continuous improvement initiatives using Lean and Six Sigma methodologies to improve process capability, yield, and throughput while identifying cost reduction opportunities. Support the transfer and scale-up of new Nitinol materials into production, execute process validation activities, and ensure adherence to FDA and ISO 13485 requirements. Partner cross-functionally with Operations, Quality, R&D, and Supply Chain to drive high-quality, efficient production of Nitinol materials and complex catheter-based devices.
Required Qualifications
- Bachelor's degree in Mechanical Engineering, Materials Science, Metallurgical Engineering, or related field
- 5+ years of manufacturing engineering experience
Desired Qualifications
- Experience in a regulated manufacturing environment (medical device, aerospace, or similar)
- Experience with metals processing; Nitinol or specialty alloys
- Knowledge of manufacturing processes such as melting, heat treatment, forming, machining, or finishing
- Experience with statistical analysis and data-driven problem solving (e.g., Minitab)
- Familiarity with process validation (IQ/OQ/PQ)
- Ability to interpret engineering drawings and GD&T
- Strong analytical and problem-solving skills
- Ability to work independently with sound technical judgment
- Effective communication and cross-functional collaboration
- High attention to detail with a focus on quality and compliance
- Continuous improvement mindset
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