Hands-On Medical Device Manufacturing Process Engineer

AngioSafe, Inc.; San Jose (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

AngioSafe, Inc. in the Bay Area seeks a Manufacturing/Process Engineer to support catheter production and scale-up while ensuring regulatory adherence and cost-effective manufacturability. This hands-on role involves direct work with manufacturing equipment on the line.

You will collaborate with assemblers and engineering to improve processes, document validation activities, and maintain quality across the manufacturing workflow in a fast-paced, small company setting.

Qualifications

• Hands-on experience on manufacturing equipment in a medical device setting.
• Experience with lamination or laser welding is required.
• Strong collaboration with production and engineering teams.
• Familiarity with MPs, LHRs, BOMs and related manufacturing documentation.
• Comfort using inspection/test equipment and working in a regulated environment.

Responsibilities

• Support the manufacturing line and advance processes to scale up.
• Create and document new manufacturing processes for high-volume production and validate as appropriate.
• Troubleshoot production equipment and handle non-conformances to keep the line moving.
• Spend significant time on the line with assemblers to improve processes and quality.
• Monitor ongoing process performance and assist fixture development for assembly and test.
• Write protocols and test reports for validation activities.
• Generate quality documentation (NCRs, CAPAs, deviations).
• Collaborate with suppliers to improve manufacturability and reduce costs.
• Qualify components from new suppliers to enhance supply chain flexibility.

Skills

Hands-on

Production equipment

Lamination

Laser welding

SolidWorks

MPs / BOMs

Inspection equipment

Regulated environment

Cross-functional collaboration

Job description

AngioSafe, Inc. in the Bay Area seeks a Manufacturing/Process Engineer to support catheter production and scale-up while ensuring regulatory adherence and cost-effective manufacturability. This hands-on role involves direct work with manufacturing equipment on the line.

You will collaborate with assemblers and engineering to improve processes, document validation activities, and maintain quality across the manufacturing workflow in a fast-paced, small company setting.