Sustaining / Process Engineer Medical Device

AngioSafe, Inc.; San Jose (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

AngioSafe, Inc. in the Bay Area seeks a Manufacturing/Process Engineer to support catheter production and scale-up while ensuring regulatory adherence and cost-effective manufacturability. This hands-on role involves direct work with manufacturing equipment on the line.

You will collaborate with assemblers and engineering to improve processes, document validation activities, and maintain quality across the manufacturing workflow in a fast-paced, small company setting.

Qualifications

• Hands-on experience on manufacturing equipment in a medical device setting.
• Experience with lamination or laser welding is required.
• Strong collaboration with production and engineering teams.
• Familiarity with MPs, LHRs, BOMs and related manufacturing documentation.
• Comfort using inspection/test equipment and working in a regulated environment.

Responsibilities

• Support the manufacturing line and advance processes to scale up.
• Create and document new manufacturing processes for high-volume production and validate as appropriate.
• Troubleshoot production equipment and handle non-conformances to keep the line moving.
• Spend significant time on the line with assemblers to improve processes and quality.
• Monitor ongoing process performance and assist fixture development for assembly and test.
• Write protocols and test reports for validation activities.
• Generate quality documentation (NCRs, CAPAs, deviations).
• Collaborate with suppliers to improve manufacturability and reduce costs.
• Qualify components from new suppliers to enhance supply chain flexibility.

Skills

Hands-on

Production equipment

Lamination

Laser welding

SolidWorks

MPs / BOMs

Inspection equipment

Regulated environment

Cross-functional collaboration

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.

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/device 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 quickly SOLVING issues with laminators, laser welders, hot boxes, etc. in order to keep the line moving.

• 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.

• Responsible for ongoing process monitoring

• Assist development of assembly and test fixturing with a focus on quality and volume

• Write protocols & test reports related to validation activities

• Generate/support Quality documentation to represent Manufacturing: NCR’s, CAPA’s, deviations, etc.

• Collaborate with existing suppliers to improve manufacturability and decrease cost

• Qualify components from new suppliers to improve supply chain flexibility

Principals only please

Skills, Experience, & Behaviors:

• Demonstrated ability to collaborate effectively, especially with a team of diverse assemblers

• 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

• 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

• Strong verbal and written communication skills

No 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.