Catheter Development & Manufacturing Process Engineer

Full-time - Mid Level

Austin, TX

Miscellaneous Manufacturing

About the position

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.

Responsibilities

• 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

Requirements

• 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

Nice-to-haves

• 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