Process Development Engineer
Process Development Engineer, Staff - Catheters
Full Time Technical
Austin, TX, US
This company is dedicated to working collaboratively with our customers, taking projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering and manufacturing. Our primary capabilities include: Nitinol components, balloon catheters, guide catheters, ablation & mapping catheters, delivery systems, biomedical textiles, access kits, and guidewires. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.
You may be who we are looking for!
This company is growing! We’re looking for Catheter Process Development Engineers to join our Austin team. Relocation assistance is available!
As a uniquely qualified candidate, you will:
- Evaluate new product specifications, create process flow map, and timeline along with PM.
- Evaluate and specify needed tooling, fixtures, and equipment to support product line.
- Develop and design new process parameters, tooling, and methods for manufacturing.
- Work ‘hands on’ with technicians to develop and define repeatable hand processes.
- Create clear and concise DMR documentation to manufacture complex catheter assemblies.
- Help train pilot production technicians, manufacturing operators, and transfer engineers in the assembly techniques, inspection methods and required documentation.
- Optimize processes to meet manufacturing quality controls, build time, cost, yield targets.
- Generate clear and concise work instructions, test methods, and visual standards.
- Design and perform Process Characterization Study’s & DOE’s, support protocols and reports.
- Have a firm understanding of validation strategy (IQ/OQ/PQ), support protocols and reports.
- Maintain cleanliness of the work environment.
- Mentor less experienced engineers.
Education and Experience:
- Bachelor of Science in Mechanical or Bio Engineering.
- Minimum 2 years experience in catheter development and 5 years medical device development
- Authoritative figure in area of expertise.
- Strong Solidworks skills. JMP or Minitab experience a plus.
- Greenbelt or higher training is a plus.
- Hands-on experience with a variety of catheter production equipment, such as: hot boxes, die-bonders, braiders, coil winders, laminators, ovens, UV adhesive light welders, laser welders, and others.
- Strong understanding of materials typical to catheter production: Pebax, Nylon, Polyurethanes, PEEK, PTFE, FEP, CA and UV adhesives, Stainless steel, NiTi, etc.
- Strong overall knowledge of entire field of work, complex level engineering experience.
- Familiar with technical literature and standards related to area of expertise.
- Extensive hands-on experience.
- Leadership skills.
- Attention to detail, professional attitude, team player
This company offers very competitive compensation and benefits and is proud to have a distinguished reputation across Silicon Valley and throughout the medical device industry around the world! We welcome eager and ambitious team players to apply!
Qualified candidates will be contacted. No phone, fax or email inquiries from potential applicants, external recruiters or other interested parties, please.
We regret that we are unable to sponsor employment visas or consider individuals on a time-limited visa status for this position.
This company is an equal opportunity employer.