Sustaining / Process Engineer Medical Device Manufacturing

AngioSafe, Inc.; San Jose (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

AngioSafe, Inc. in the Bay Area seeks a hands-on Manufacturing/Process Engineer to support catheter production, drive process improvements, and ensure regulatory compliance. The role requires direct work on manufacturing equipment and a practical, manufacturing-focused mindset.

You will collaborate with operators, qualify processes, and help scale up high‑volume production. The position emphasizes close collaboration with production teams to optimize yield, reduce waste, and maintain

Qualifications

• 5+ years in medical device manufacturing.
• Hands-on experience with production equipment.
• Experience with lamination or laser welding.
• Editing MPs, LHRs, and BOMs.

Responsibilities

• Primary focus: Support the manufacturing line and advance the processes and device in order to support scale up.
• Create and document new manufacturing processes as necessary for production at significantly high volumes and validate as appropriate.
• Support ongoing manufacturing activities including dealing with production equipment, non‑conformances, facilities and other line related issues. This includes SOLVING issues with laminators, laser welders, hot boxes, etc.
• Spend significant time on the manufacturing line alongside the assemblers to improve processes and increase quality. You are the primary interface between engineering and production.
• Assist development of assembly and test fixturing with a focus on quality and volume.
• Write protocols & test reports related to validation activities.
• Collaborate with existing suppliers to improve manufacturability and decrease cost.
• Qualify components from new suppliers in order to improve supply chain flexibility.

Skills

Medical device manufacturing

Hands-on production equipment

Lamination

Laser welding

Process documentation

Quality assurance

Job description

AngioSafe is a Bay Area start-up focusing on improving healthcare delivery through state-of-the-art catheter development. Our seasoned experts are committed to producing high quality and innovative products to decrease risk and improve outcomes of arterial disease.

Manufacturing/Process Engineer to support the production and improvement of our innovative catheters ensuring high reliability, regulatory adherence, and cost‑effective manufacturability. This is a hands‑on role requiring direct involvement with manufacturing equipment. Candidates with primarily theoretical or design‑only backgrounds will not be a fit.

Roles and Responsibilities

• Primary focus: Support the manufacturing line and advance the processes and device in order to support scale up.
• Create and document new manufacturing processes as necessary for production at significantly high volumes and validate as appropriate.
• Support ongoing manufacturing activities including dealing with production equipment, non‑conformances, facilities and other line related issues. This includes SOLVING issues with laminators, laser welders, hot boxes, etc.
• Spend significant time on the manufacturing line alongside the assemblers to improve processes and increase quality. You are the primary interface between engineering and production.
• Assist development of assembly and test fixturing with a focus on quality and volume.
• Write protocols & test reports related to validation activities.
• Collaborate with existing suppliers to improve manufacturability and decrease cost.
• Qualify components from new suppliers in order to improve supply chain flexibility.

Skills, Experience, & Behaviors

• Solid history of experience in a medical device manufacturing environment (~5+ years preferred).
• Hands‑on mechanical aptitude with direct experience working on production equipment is required.
• Solid experience with either lamination or laser welding is required.
• Proven experience editing Manufacturing Procedures (MPs), Lot History Records (LHRs), Bills of Materials (BOMs), etc. is required.
• Comfort using inspection and test equipment (vision systems, tensile testing) is a plus.
• Experience working within and maintaining compliance in a highly regulated environment.
• Demonstrated ability to work independently in a fast‑paced, small company environment.
• Flexibility and willingness to take on a variety of roles.
• Demonstrated ability to collaborate effectively, especially with a team of diverse assemblers.
• Strong verbal and written communication skills.

No relocation or immigration support provided for this role.

Principals only Please

AngioSafe is committed to a diverse workplace and is committed to equal opportunity employment for all job applicants without regard to race, color, religion, sex, sexual orientation, age, gender, gender identity or expression, size, national origin, disability, or veteran status. AngioSafe complies with all applicable local, state, and national laws governing non‑discrimination in employment.