Job Description:We are looking for a
Process Development Engineer, Senior Staff to join our Austin, TX team. As a uniquely qualified candidate, you will:
- Work in a team environment to accomplish scientific approaches to complex Catheter development.
- Develop manufacturing processes for products in the area of complex catheters.
- Perform process analysis, improvements and process validation (IQ/OQ/PQ)
- Create reports and/or other communications to effectively report engineering findings.
- Works with cross-functional teams to become a pivotal member of Confluent engineering
- Support new product introduction, cost reduction, and revenue generating projects
- Develop and design new process parameters, tooling, and methods for manufacturing.
- Optimize processes to meet manufacturing quality controls, build time, cost, yield targets.
- Generate clear and concise work instructions, test methods, and visual standards.
- Perform Process Characterization Study's using appropriate statistical techniques including DOE's, support protocols and reports.
- Design and develop fixtures and semi-automated equipment for the assembly of complex catheters to meet cost and throughput objectives
- Technical support manufacturing including production related matters involving day to day troubleshooting
- Train production personnel as required
- Maintain cleanliness of the work environment.
- Mentor less experienced engineers.
- Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
- Practice company safety and quality, policies and procedures that actively require conformance.
- Contribute to the effectiveness of the quality system by actively participating in NCR's, complaints, CAPA's, and root cause investigations
Education and Experience: - Bachelor of Science in Mechanical/Chemical/Bio-Engineering. Equivalent work experience maybe considered in extenuating circumstances.
- 9-12 years of experience in medical device manufacturing and development
- Hands-on experience with a variety production equipment used in complex catheters manufacturing process is preferred (Braiding, Lamination, extrusion, laser welding, hot bonding).
- Strong materials process understanding of: Polyimide, PTFE, FEP, Pebax, Nylons, and Urethanes is preferred
- Experience applying a variety of statistical analysis techniques (Ppk, ANOVA, DOE, etc.)
- Experience designing fixtures and simple semi-automated equipment using SolidWorks is preferred
- Authoritative figure in area of expertise.
- Greenbelt or higher training is preferred.
- 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
We regret that we are unable to sponsor employment visas or consider individuals on time-limited visa status for this position.
Only qualified candidates will be contacted.
