Sustaining / Process Engineer Medical Device
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.
- 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.
- 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.
Nice To Haves
- Proficiency in SolidWorks is helpful but not 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.
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.
- Solve issues with laminators, laser welders, hot boxes, etc.
- Spend significant time on the manufacturing line alongside the assemblers to improve processes and increase quality.
- Act as 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
