Senior Manager, Engineering

Confluent Medical Technologies•Austin, TX

13d•Onsite

About The Position

Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking 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, catheters, delivery systems, biomedical textiles, access kits, and guidewires. 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 are looking for a Senior Manager, Engineering to join our Austin, TX team! As a uniquely qualified candidate, you will: Manage, mentor and provide career development support to team of Engineers and Technicians 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. Be responsible for planning, executing and supervising process development related to catheter development. Be responsible for process identification, parameter optimization, proof of concept testing, technology improvements, and process implementation. Be responsible for tool and fixture 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. Be responsible for screening and optimization of process parameters to achieve robust and stable processes and maximize yields, efficiencies and process capabilities. Be responsible for documentation of studies in engineering memorandums and work instructions. Identify and investigate and develop new technologies for catheter processing. Create clear and concise DMR documentation to manufacture complex catheter assemblies. Help train pilot production technicians, manufacturing operators, and transfer engineers in the assembly techniques, inspection methods and required documentation. 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. 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. Manage, mentor and provide career development support to a team of engineers and technicians. Applying materials science to MedTech innovation. Confluent specializes in expert design and development of large-scale manufacturing specializing in interventional catheter-based devices and implants. Our key capabilities include Nitinol components and tubing, balloon and complex catheters, high-precision polymer tubing, and implantable textiles. We operate in 8 state-of-the-art facilities across the United States and Costa Rica and currently employ over 2,000 employees. Confluent has earned the confidence of leaders in the medical device community through a proven track record of innovation, engineering, and manufacturing. Visit www.confluentmedical.com to learn more.

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
Possess 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 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

Nice To Haves

Six Sigma Black Belt preferred

Responsibilities

Manage, mentor and provide career development support to team of Engineers and Technicians
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.
Be responsible for planning, executing and supervising process development related to catheter development.
Be responsible for process identification, parameter optimization, proof of concept testing, technology improvements, and process implementation.
Be responsible for tool and fixture 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.
Be responsible for screening and optimization of process parameters to achieve robust and stable processes and maximize yields, efficiencies and process capabilities.
Be responsible for documentation of studies in engineering memorandums and work instructions.
Identify and investigate and develop new technologies for catheter processing.
Create clear and concise DMR documentation to manufacture complex catheter assemblies.
Help train pilot production technicians, manufacturing operators, and transfer engineers in the assembly techniques, inspection methods and required documentation.
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.
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.
Manage, mentor and provide career development support to a team of engineers and technicians.