Sustaining / Process Engineer Medical Device Manufacturing

AngioSafe, Inc.; San Jose (CA); On-site; USD 95,000 - 130,000; Full time

Job summary

AngioSafe, a Bay Area startup, seeks a Manufacturing/Process Engineer to support catheter production and process improvement ensuring high reliability and regulatory adherence. This hands-on role requires direct involvement with manufacturing equipment and collaboration with assemblers and suppliers.

The successful candidate will have 5+ years in medical device manufacturing, hands-on equipment experience, and the ability to work independently in a fast-paced, small company environment in the

Qualifications

• ≥5 years in a medical device manufacturing environment.
• Hands-on experience with production equipment is required.
• Experience with lamination or laser welding is required.
• Experience editing MPs, LHRs, BOMs, etc. is required.
• Experience in a highly regulated environment is preferred.

Responsibilities

• Support the manufacturing line and advance processes for scale-up.
• Create and document new manufacturing processes for higher volumes and validate them.
• Support ongoing manufacturing activities and address line issues (lamination/laser welding/other equipment).
• Work on the manufacturing line with assemblers to improve processes and quality; serve as the engineering-production interface.
• Assist development of assembly/test fixtures; write protocols and test reports for validation.
• Collaborate with suppliers to improve manufacturability and reduce cost.
• Qualify components from new suppliers to improve supply chain flexibility.

Skills

Hands-on production equipment

Lamination experience

Laser welding experience

MPs/LHRs/BOMs editing

Regulatory compliance

Quality improvement

Cross-functional collaboration

Strong communication

Tools

SolidWorks

Vision systems

Tensile testing equipment

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 aManufacturing/ProcessEngineerto support the productionand improvementof our innovative catheters ensuring high reliability, regulatory adherence, and cost-effective manufacturability.This is a hands-on role requiring direct involvementwithmanufacturing 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 supportprovidedfor this role.

Principals only Please

AngioSafeis 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.AngioSafecomplies withall applicable local, state, and national laws governing non-discrimination in employment.