Salary Range:
$123,000.00 - $205,000.00
Job Description:
Confluent 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, balloon expandable stents and balloon 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 Advanced Engineering Talent to join our teams in Fremont, CA and Austin, TX. As a uniquely qualified candidate, you will be responsible for production planning and inventory control for multiple products while prioritizing operations to ensure maximum performance and minimum delay. This individual will take a lead role in continuous improvement, product flow and capacity improvement to improve the overall efficiency of manufacturing while service level targets.
Relocation assistance is available for both the Austin, TX and Fremont, CA locations.
Under the direction of the Director of Engineering, be responsible for process development – from initial development to sustained manufacturing validation – planning, directing, and coordinating engineering activities, studies and programs in support of standard production and new product development. Documentation of design ideas and technical drawings.
Fremont, CA facility: Nitinol Materials and Components
- Responsible for planning, executing and supervising process development related to: mechanical processing (forming, tool design, machining, grinding, EDM) and surface processing (micro-blasting, chemical etching, electro-polishing)
- Manage a team of engineers and technicians responsible for achieving robust and stable processes that maximize yields, efficiencies and process capabilities. Set priorities and timeline for development projects.
- Responsible for training engineers, technicians and operators as well as provide mentorship and career development support to engineers and technicians Interface and collaborate with New Product Development, Sustaining, Quality, and Equipment Engineering groups.
- Provide critical input for design and build of equipment required for processing Nitinol.
- Support and provide equipment guidelines and tooling modifications for process improvements.
- Responsible for documentation of studies in engineering memorandums and work instructions.
- Identify, investigate and develop new technologies for Nitinol processing.
- Develop strategic processing goals and objectives and integrate processes into Lean value streams.
- Responsible for team budget and capital appropriation based on sound testing and demonstrated feasibility.
- Additional duties as necessary.
Austin, TX facility: Advanced Catheter Systems
- Evaluate new product specifications, create process flow map, and timeline along with PM.
- Evaluate and specify needed tooling, fixtures, and equipment to support product line.
- Develop and design new process parameters, tooling, and methods for manufacturing.
- Work ‘hands on’ with technicians to develop and define repeatable hand processes.
- 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.
- Additional duties as necessary.
Education and Experience:
- BS in Mechanical Engineering or related discipline
- Minimum 8 -12 years’ experience in a related field
- Excellent Solid works modeling skills required Experience in the medical device industry
- Possess excellent English communication skills – both written and oral.
These are hands-on roles within Confluent. We look for individuals that are proactive in developing cohesive teams and mentoring junior level engineers. Confluent strongly encourages an environment that fosters growth for the individual as well as the company. If such an approach intrigues you, feel free to visit our website to review our company as well as our current roles we are actively recruiting for.
Top Skills
What We Do
Confluent Medical Technologies applies 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.