Sustaining / Process Engineer

AngioSafe • San Jose, CA

1d • Onsite

About The Position

AngioSafe is a Bay Area company focusing on improving healthcare through state-of-the-art vascular interventional catheter device design, development and manufacturing. We are pioneering the development of novel treatment mechanisms and algorithms to provide unprecedented access to peripheral and coronary disease treatments. Our seasoned experts are committed to developing and commercializing high-quality and innovative products to decrease risk and improve outcomes of cardiovascular disease treatment. This onsite role will have a meaningful impact on AngioSafe’s devices, supporting the production and improvement of our innovative catheters, ensuring high reliability, regulatory adherence, and cost-effective manufacturability.

Requirements

• Solid history of experience in medical device manufacturing environment, roughly 5 years preferred
• Strong preference for lamination, laser welding and UV curing expertise
• Proficient in Solidworks
• Proven experience editing MP’s, LHR’s, BOM’s etc.
• Demonstrated comfort using inspection & test equipment (vision systems, tensile testing)
• Ability to work within & maintain compliance to highly regulated environment
• Demonstrated ability to work independently
• Flexibility and willingness to take on a variety of roles in a small company
• Demonstrated ability to collaborate effectively, especially with team of diverse assemblers
• Strong verbal and written communication skills

Responsibilities

• Primary focus is supporting the manufacturing line & advancing the processes and devices 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.
• Spending significant time on the manufacturing line alongside the assemblers to improve processes and increase quality; 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 to improve supply chain flexibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed
• Number of Employees: 1-10 employees