Hands-On Med Device Process Engineer — Lamination & Weld

AngioSafe, Inc.; San Jose (CA); On-site; USD 95,000 - 130,000; Full time

Job summary

AngioSafe, a Bay Area startup, seeks a Manufacturing/Process Engineer to support catheter production and process improvement ensuring high reliability and regulatory adherence. This hands-on role requires direct involvement with manufacturing equipment and collaboration with assemblers and suppliers.

The successful candidate will have 5+ years in medical device manufacturing, hands-on equipment experience, and the ability to work independently in a fast-paced, small company environment in the

Qualifications

• ≥5 years in a medical device manufacturing environment.
• Hands-on experience with production equipment is required.
• Experience with lamination or laser welding is required.
• Experience editing MPs, LHRs, BOMs, etc. is required.
• Experience in a highly regulated environment is preferred.

Responsibilities

• Support the manufacturing line and advance processes for scale-up.
• Create and document new manufacturing processes for higher volumes and validate them.
• Support ongoing manufacturing activities and address line issues (lamination/laser welding/other equipment).
• Work on the manufacturing line with assemblers to improve processes and quality; serve as the engineering-production interface.
• Assist development of assembly/test fixtures; write protocols and test reports for validation.
• Collaborate with suppliers to improve manufacturability and reduce cost.
• Qualify components from new suppliers to improve supply chain flexibility.

Skills

Hands-on production equipment

Lamination experience

Laser welding experience

MPs/LHRs/BOMs editing

Regulatory compliance

Quality improvement

Cross-functional collaboration

Strong communication

Tools

SolidWorks

Vision systems

Tensile testing equipment

Job description

AngioSafe, a Bay Area startup, seeks a Manufacturing/Process Engineer to support catheter production and process improvement ensuring high reliability and regulatory adherence. This hands-on role requires direct involvement with manufacturing equipment and collaboration with assemblers and suppliers.

The successful candidate will have 5+ years in medical device manufacturing, hands-on equipment experience, and the ability to work independently in a fast-paced, small company environment in the