Sustaining / Process Engineer Medical Device

AngioSafe • San Jose, CA

4d • Onsite

About The Position

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.

Requirements

• 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.
• Experience with lamination, laser welding, and UV curing processes is required.
• Proficiency in SolidWorks is required.
• Proven experience editing Manufacturing Procedures (MPs), Lot History Records (LHRs), Bills of Materials (BOMs), etc. is required.
• Demonstrated comfort using inspection and test equipment (vision systems, tensile testing).
• 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.

Responsibilities

• 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.
• Spending 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed