Engineering Manager

About the role

Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking projects from rapid prototype into high volume production. Our primary capabilities include Nitinol components, catheters, delivery systems, biomedical textiles, access kits, and guidewires.

Responsibilities

• Manage, mentor and provide career development support to a team of Engineers and Technicians.
• Assign engineering resources to project teams and ensure on-time completion of technical activities.
• Be responsible for process development – from initial development to sustained manufacturing validation, planning, directing, and coordinating engineering activities, studies and programs in support of new product development.
• Plan, execute and supervise process development related to catheter development from early-phase development and initial low-volume builds in Austin through transfer to Costa Rica for long-term high-volume manufacturing.
• Ensure that manufacturing processes are developed to meet long-term manufacturing goals and cost targets outlined in the project business case.
• Be responsible for process identification, parameter optimization, proof of concept testing, technology improvements, and process implementation.
• Be responsible for tool, fixture, and equipment design and qualification used for manufacturing medical devices and components.
• Provide critical input for design and build of equipment required for processing catheters.
• Support and provide equipment guidelines and tooling modifications for process improvements.
• Screen and optimize process parameters to achieve robust and stable processes and maximize yields, efficiencies and process capabilities.
• Document studies in engineering memorandums and work instructions.
• Identify, investigate and develop new technologies for catheter processing.
• Create clear and concise Medical Device File (MDF) documentation to manufacture complex catheter assemblies.
• Help train pilot production technicians, manufacturing operators, and transfer engineers in assembly techniques, inspection methods and required documentation.
• Optimize processes to meet manufacturing quality controls, build time, cost, and yield targets.
• Generate clear and concise work instructions, test methods, and visual standards.
• Design and perform Process Characterization Studies & DOEs, support protocols and reports.
• Have a firm understanding of validation strategy (IQ/OQ/PQ), support protocols and reports.
• Be responsible for team budget and capital appropriation based on sound testing and demonstrated feasibility.

Requirements

• BS degree in a relevant discipline and 12 or more years of related engineering and management experience. Or: MS degree and 8 or more years of related experience. Or: Ph.D. and 6 or more years of related experience.
• Experience in the medical device industry.
• 2+ years of leadership and people management experience.
• Six Sigma Black Belt preferred.
• Excellent English communication skills – both written and oral.
• Hands-on experience with a variety of catheter production equipment, such as: hot boxes, die-bonders, braiders, coil winders, laminators, ovens, UV adhesive light welders, laser welders, and others.
• Strong understanding of materials typical to catheter production: Pebax, Nylon, Polyurethanes, PEEK, PTFE, FEP, CA and UV adhesives, Stainless steel, NiTi, etc.
• Strong overall knowledge of the entire field of work, complex-level engineering experience.
• Familiar with technical literature and standards related to area of expertise.
• Extensive hands-on experience.
• Leadership and people management experience.
• Attention to detail, professional attitude, team player.

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