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About the Role
Confluent Medical Technologies is seeking a Process Development Engineer II to join their team in Austin, Texas. This role involves working in a collaborative environment to develop life-saving medical devices, specifically focusing on complex catheter development and manufacturing.
Responsibilities
- 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
Requirements
- 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
- 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
- Leadership skills
- Attention to detail, professional attitude, team player
Skills
- SolidWorks
- Minitab
- Greenbelt or higher training
- Statistical analysis techniques (Ppk, ANOVA, DOE, etc.)
- Processing catheter materials (Polyimide, PTFE, FEP, Pebax, Nylons, and Urethanes)
Location
- Austin, Texas
Work Type
- Full-time
Experience Level
- 3-6+ years (with BS)
- 1-4 years (with MS)
Education Level
- Bachelor of Science in Materials, Mechanical, Bio Engineering or other relevant degree
- Master’s degree preferred
About the Company
- Confluent Medical Technologies is a financially healthy and rapidly growing medical device company.
- Employees are passionate about providing life-saving solutions.
- Offers a collaborative and high-impact work environment.
- Moderate size, diversity of technologies, and broad material science capabilities allow employees to develop broad skill sets and directly influence product development and manufacturing outcomes.
- Dedicated to working collaboratively with customers, taking projects from rapid prototype into high volume production.
- Unparalleled technical expertise, proven experience, and partnership with clients.
- Perfected the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing.
- Primary capabilities include: Nitinol components and tubing, balloon expandable stents and catheters, complex catheters, biomedical textiles, and high precision polymer tubing.
- Takes pride in its position as the leader in the medical technology space.
- Driven by a passion to create products that clients have envisioned for their customers.
Equal Opportunity
- Confluent Medical Technologies is an equal opportunity employer.
- Regret that we are unable to sponsor employment visas or consider individuals on time-limited visa status for this position.