Engineering Manager

Confluent Medical Technologies; Austin (TX); On-site; USD 150,000 - 210,000; Full time

Job summary

Confluent Medical Technologies in Austin, TX is seeking a Manager, Engineering to lead a team of engineers and technicians. You will drive process development from early concept through validation and transfer to Costa Rica for high-volume manufacturing.

You will manage project resources, supervise process optimization, and ensure manufacturing goals and cost targets are met while maintaining rigorous documentation and design control for catheter products.

Qualifications

• Experience leading engineering teams in medical device or related industries.
• Strong communication and mentoring skills for cross-functional teams.
• Proven ability to drive projects from concept through validation and transfer to manufacturing.

Responsibilities

• Lead and mentor Engineers and Technicians in project delivery.
• Allocate resources and ensure on-time completion of technical activities.
• Oversee development activities from concept to manufacturing validation and transfer.
• Plan and supervise catheter development processes for pilot to high-volume production.
• Ensure processes meet long-term manufacturing goals, cost targets and quality standards.

Skills

Leadership

People management

Project management

English communication

Education

BS degree in a relevant discipline

MS degree

Ph.D.

Job description

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 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
• 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.
• Be responsible for planning, executing and supervising process development related to catheter development from project early phase development and initial low volume builds in Austin through transfer to Costa Rica for long-term high-volume manufacturing.
• Responsible for ensuring 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.
• 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 Medical Device File (MDF) 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 Studies & 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.

Education and Experience:

• 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.
• 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.

Confluent Medical Technologies is an equal opportunity employer.

Only qualified candidates will be contacted.