Confluent Medical Technologies is a financially healthy and rapidly growing medical device company whose employees are passionate about providing life-saving solutions to our customers through a collaborative and high-impact work environment. Our moderate size, diversity of technologies, and broad material science capabilities provide an environment in which our employees can develop broad skill sets and directly influence product development and manufacturing outcomes.

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

Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components and tubing, balloon expandable stents and catheters, complex catheters, biomedical textiles, and high precision polymer tubing. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.

We regret that we are unable to sponsor employment visas or consider individuals on time-limited visa status for this position.

Confluent Medical Technologies is an equal opportunity employer.

Only qualified candidates will be contacted.