Process Development Engineer II
Confluent Medical Technologies
Summary
Work in a team environment to accomplish scientific approaches to complex catheter development.
Job description
Develop and design new process parameters, tooling, and methods for manufacturing complex catheters.
Perform Process Characterization Studies using appropriate statistical techniques including DOEs, 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 NCRs, complaints, CAPAs, and root cause investigations.
Play a technical lead role in projects with moderate complexity as needed to guide, mentor and get results.
Requirements
- 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
Company overview
Confluent Medical Technologies is a leading medical device contract development and manufacturing organization (CDMO) that applies advanced materials science to MedTech innovation. Founded in 1991 and headquartered in Scottsdale, Arizona, the company specializes in the expert design, development, and large-scale manufacturing of interventional catheter-based devices and implants. With over 2,000 employees across eight state-of-the-art facilities in the United States and Costa Rica, Confluent has established itself as a trusted partner to major medical device companies worldwide. The company's core capabilities include Nitinol components and tubing, balloon and complex catheters, high-precision polymer tubing, and implantable biomedical textiles. Confluent's vertically integrated supply chain approach brings design, development, and manufacturing together under one roof, enabling faster time-to-market and greater innovation for its customers. The company serves the cardiovascular, neurovascular, and structural heart markets, providing life-saving solutions through its expertise in shape memory alloys and polymer technologies. Confluent Medical Technologies has earned the confidence of industry leaders through its proven track record of innovation, engineering excellence, and manufacturing reliability. The company's commitment to quality, safety, and customer satisfaction has positioned it as a critical partner in advancing minimally invasive medical technologies that improve patient outcomes globally.