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