Sustaining Process Engineer Medical Device

AngioSafe; San Jose (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

AngioSafe is seeking a Sustaining / Process Engineer in San Jose, CA. This full-time position involves supporting the manufacturing of innovative catheters in a hands-on role. The ideal candidate will have over 5 years of medical device manufacturing experience and be adept in solving production issues. Responsibilities include process documentation, manufacturing support, and supplier collaboration. The company values diversity and equal opportunity in employment.

Qualifications

• 5+ years of experience in a medical device manufacturing environment.
• Experience working on production equipment is required.
• Proficiency in editing Manufacturing Procedures, Lot History Records, Bills of Materials is required.

Responsibilities

• Support the manufacturing line and advance processes for scale up.
• Create and document manufacturing processes for production.
• Solve issues with laminators, laser welders, hot boxes during production.
• Collaborate with suppliers to improve manufacturability.

Skills

Medical device manufacturing experience

Hands-on mechanical aptitude

Experience with lamination or laser welding

Editing Manufacturing Procedures (MPs)

Comfort using inspection and test equipment

Strong communication skills

Tools

SolidWorks

Job description

Role: Sustaining / Process Engineer
Company: AngioSafe
Location: San Jose, CA
Position Type: Full-Time on site

Overview

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.

We are seeking a 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 higher 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.
• Proficiency in SolidWorks is helpful but not 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.

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.