Catheter Development & Manufacturing Process Engineer

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 developmentDevelop and execute validation protocolsPerform process analysis, improvements and process validation (IQ/OQ/PQ)Create reports and/or other communications to effectively report engineering findingsWork with cross-functional teams to become a pivotal member of Confluent engineeringLead new product introduction, cost reduction, and revenue generating projectsDevelop and design new process parameters, tooling, and methods for manufacturingOptimize processes to meet manufacturing quality controls, build time, cost, yield targetsGenerate 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 engineersPerform 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 resultsEducation and Experience: Bachelor of Science in Materials, Mechanical, Bio Engineering or other relevant degree5+ years of experience in medical device developmentProficiency in SolidWorksFamiliarity with design control for process development and design development of medical devices Experience with authorship of design control documents for medical devicesA 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 plusFamiliarity with technical literature and standards related to area of expertise Extensive hands-on experience Leadership skillsAttention to detail, professional attitude, team player Design for manufacturability (DFM) a plusExperience 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 plusExperience and understanding of the design for plastics injection-mold fabrication processes a plusConfluent 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.