We are looking for a
Catheter Development & Manufacturing Process Engineer 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 devices development
- 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
- 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
- Design and perform Process Characterization Study's & DOE's, support protocols and reports
- 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
- Play a technical lead role in required projects as needed to guide, mentor and get results
Education and Experience: - Bachelor of Science in Materials, Mechanical, Bio Engineering or other relevant degree
- 5+ years of experience in medical device development
- 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 a plus
- Greenbelt or higher training is a plus
- Hands-on experience with a variety of catheter or balloon production equipment a plus
- Familiarity with technical literature and standards related to area of expertise
- Extensive hands-on experience
- Leadership skills
- Attention to detail, professional attitude, team player
- Design for manufacturability (DFM) a plus
- Experience developing designs and testing via a phase-gate analysis (Concept, Feasibility, Verification) using a risk-based approach, including creation of risk assessments & failure modes and effects analysis (RA/FMEA) a plus
- Experience and understanding of the design for plastics injection-mold fabrication processes a plus
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.
