Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their 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 expandable stents and balloon 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.
We are looking for a Process Development Engineer, Senior Staff to join our
Austin, TX team. As a uniquely qualified candidate, you will
- 01Work in a team environment to accomplish scientific approaches to complex Catheter development.
- 02Develop manufacturing processes for products in the area of complex catheters.
- 03Perform process analysis, improvements and process validation (IQ/OQ/PQ)
- 04Create reports and/or other communications to effectively report engineering findings.
- 05Works with cross-functional teams to become a pivotal member of Confluent engineering
- 06Support new product introduction, cost reduction, and revenue generating projects
- 07Develop and design new process parameters, tooling, and methods for manufacturing.
- 08Optimize processes to meet manufacturing quality controls, build time, cost, yield targets.
- 09Generate clear and concise work instructions, test methods, and visual standards.
- 10Perform Process Characterization Study’s using appropriate statistical techniques including DOE’s, support protocols and reports.
- 11Design and develop fixtures and semi-automated equipment for the assembly of complex catheters to meet cost and throughput objectives
- 12Technical support manufacturing including production related matters involving day to day troubleshooting
- 13Train production personnel as required
- 14Maintain cleanliness of the work environment.
- 15Mentor less experienced engineers.
- 16Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
- 17Practice company safety and quality, policies and procedures that actively require conformance.
- 18Contribute to the effectiveness of the quality system by actively participating in NCR’s, complaints, CAPA’s, and root cause investigations
Education and Experience
- 19Bachelor of Science in Mechanical/Chemical/Bio-Engineering. Equivalent work experience maybe considered in extenuating circumstances.
- 209-12 years of experience in medical device manufacturing and development
- 21Hands-on experience with a variety production equipment used in complex catheters manufacturing process is preferred (Braiding, Lamination, extrusion, laser welding, hot bonding).
- 22Strong materials process understanding of: Polyimide, PTFE, FEP, Pebax, Nylons, and Urethanes is preferred
- 23Experience applying a variety of statistical analysis techniques (Ppk, ANOVA, DOE, etc.)
- 24Experience designing fixtures and simple semi-automated equipment using SolidWorks is preferred
- 25Authoritative figure in area of expertise.
- 26Greenbelt or higher training is preferred.
- 27Strong overall knowledge of entire field of work, complex level engineering experience.
- 28Familiar with technical literature and standards related to area of expertise.
- 29Extensive hands-on experience
- 30Leadership skills
- 31Attention to detail, professional attitude, team player
We regret that we are unable to sponsor employment visas or consider individuals on time-limited visa status for this position.
Confluent Medical Technologies is an equal opportunity employer.
Only qualified candidates will be contacted.
États-Unis
