Sustaining / Process Engineer Medical Device
AngioSafe
Summary
AngioSafe is a Bay Area start-up focusing on improving healthcare delivery through state-of-the-art catheter development. 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.
Job description
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.
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.
Requirements
- 5+ years experience in a medical device manufacturing environment (preferred)
- Hands-on mechanical aptitude with direct experience working on production equipment
- Solid experience with either lamination or laser welding
- Experience editing Manufacturing Procedures (MPs), Lot History Records (LHRs), Bills of Materials (BOMs)
- Experience working within and maintaining compliance in a highly regulated environment
- Demonstrated ability to work independently in a fast-paced, small company environment
- Strong verbal and written communication skills
- Demonstrated ability to collaborate effectively with a team of diverse assemblers
- Proficiency in SolidWorks (helpful but not required)
- Comfort using inspection and test equipment (vision systems, tensile testing) is a plus
Company overview
AngioSafe is a medical device company specializing in innovative solutions for cardiovascular interventions and angiography procedures. The company focuses on developing advanced safety technologies designed to enhance patient outcomes during complex vascular procedures. AngioSafe's product portfolio likely includes specialized devices and systems that improve the precision and safety of angiography, potentially incorporating features such as radiation reduction, contrast media management, or procedural monitoring capabilities. As a player in the cardiovascular medical device sector, AngioSafe addresses critical needs in interventional cardiology and radiology by providing tools that help healthcare professionals perform safer, more efficient procedures. The company operates at the intersection of medical technology and patient safety, contributing to the advancement of minimally invasive cardiovascular treatments. While specific product details are not available from current searches, the company's name suggests a strong emphasis on safety innovations within the angiography and interventional cardiology space, positioning it as a potential contributor to improved clinical practices and patient care standards in cardiovascular medicine.