Manufacturing Engineer, Staff - BAYP4031
Confluent Medical Technologies•Fremont, CA
•$103,900 - $173,100•Hybrid
About The Position
The Manufacturing Engineer, Staff is a fully competent individual contributor responsible for supporting and optimizing manufacturing processes within the Nitinol Materials operations. This role provides hands-on engineering support, drives continuous improvement initiatives, and partners cross-functionally to ensure high-quality, efficient production of Nitinol materials. The role operates with minimal supervision on moderately complex problems and contributes to process scalability, cost efficiency, and product quality.
Requirements
- Bachelor’s degree in Mechanical Engineering, Materials Science, Metallurgical Engineering, or related field
- 5+ years of manufacturing engineering experience.
- Experience in a regulated manufacturing environment (medical device, aerospace, or similar) preferred
- Experience with metals processing; Nitinol or specialty alloys strongly preferred
- 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
Responsibilities
- Provide daily engineering support for Nitinol melting, casting, and downstream material processing operations
- Troubleshoot process, material, and equipment issues to minimize downtime and scrap
- Develop, update, and maintain manufacturing documentation including work instructions and process specifications
- Monitor and analyze process performance and implement improvements
- Lead and support continuous improvement initiatives using Lean and Six Sigma methodologies
- Improve process capability (Cp/Cpk), yield, and throughput
- Identify and implement cost reduction opportunities through process optimization and material utilization
- Support transfer and scale-up of new Nitinol materials and processes into production
- Assist with process development, manufacturability assessments, and production readiness
- Execute process validation activities (IQ/OQ/PQ) and ensure compliance with internal requirements
- Ensure adherence to FDA, ISO 13485, and internal quality system requirements
- Support nonconformance investigations, root cause analysis, and corrective/preventive actions (CAPA)
- Partner with Quality to define process controls and inspection requirements
- Partner cross-functionally with Operations, Quality, R&D, and Supply Chain
- Provide technical guidance to operators, technicians, and junior engineers
- Contribute to a culture of safety, accountability, and continuous improvement
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What This Job Offers
Job Type
Full-time
Career Level
Senior
