Job Description:We are looking for a
Process Development Engineer II to join our talented team in beautiful
Austin, Texas.
As a uniquely qualified candidate, you will:
- Work in a team environment to accomplish scientific approaches to complex catheter development
- Develop and design new process parameters, tooling, and methods for manufacturing complex catheters
- 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
- Develop and execute validation protocols
- Perform process analysis, improvements and process validation (IQ/OQ/PQ)
- Create reports and/or other communications to effectively report engineering findings
- Work with cross-functional teams to become a pivotal member of Confluent engineering
- Lead new product introduction, cost reduction, and revenue generating projects
- Optimize processes to meet manufacturing quality controls, build time, cost, yield targets
- Generate clear and concise work instructions, test methods, and visual standards
- Maintain cleanliness of the work environment
- Mentor less experienced engineers
- Perform design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes
- Plan, schedule, conduct, and coordinate detailed phases of engineering work in part of a major project or in a total project of moderate scope
- Contribute to the effectiveness of the quality system by actively participating in NCR's, complaints, CAPA's, and root cause investigations
- Play a technical lead role in projects with moderate complexity as needed to guide, mentor and get results
Education and Experience: - Bachelor of Science in Materials, Mechanical, Bio Engineering or other relevant degree. Master's degree preferred.
- 3-6+ years of experience in medical device development with a BS, 1-4 years with a MS
- Proficiency in SolidWorks
- Familiarity with design control for process development and design development of medical devices
- Experience with authorship of design control documents for medical devices
- A firm understanding of validation strategy (IQ/OQ/PQ), support protocols and reports
- Strong Solidworks skills. Minitab experience is a plus
- Greenbelt or higher training is a plus
- Familiarity of a variety of statistical analysis techniques (Ppk, ANOVA, DOE, etc.)
- Hands-on experience required, preferably with a variety of catheter or medical device production equipment
- Familiarity with technical literature and standards related to area of expertise
- Familiarity with processing catheter materials of: Polyimide, PTFE, FEP, Pebax, Nylons, and Urethanes is preferred
- 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.
