Full-Time
Quality Engineer
Updated on 9/3/2026
Confluent Medical Technologies
1,001-5,000 employees
Contract manufacturer of Nitinol medical devices
Compensation Overview
$90.8k - $151.3k/yr
No H1B Sponsorship
Laguna Niguel, CA, USA
In Person
Bachelor's, Master's
 Manufacturing Quality & Test (1) |
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- Bachelor of Science in a related engineering discipline and 5 years of related experience working in Quality in a medical device environment, or equivalent combination of education and experience.
- Master of Science in a related engineering discipline and 4 years of related experience working in Quality in a medical device environment, or equivalent combination of education and experience.
- At least 5 years of experience in medical device product development.
- At least 5 years of experience with FDA, ISO 13485, and European Union Medical Device Regulation design control requirements.
- Demonstrated knowledge and practical application of ISO 14971 requirements.
- Strong statistical data analysis skills using Minitab, including process capability and data normality assessments, analysis of variance, hypothesis testing, determining appropriate sample sizes, tolerance interval assessments, variable and attribute sampling plan applications, design of experiments, and response surface models.
- Competence in Microsoft Office applications.
- Ability to work in compliance with Federal, State, local, and company regulations, policies, and procedures for health, safety, and environmental compliance.
- Ensure compliance with customer, risk management, quality, and design control requirements in design and development projects and help ensure successful transfer of designs to manufacturing.
- Analyze problems and projects of moderate to complex scope using industry regulations, best practices, and critical thinking.
- Participate in decisions on scope of work, selection of materials, equipment and test methodology, task duration, and design changes to meet revised specifications.
- Develop, apply, revise, and maintain quality and regulatory standards for designing and processing materials and products into partially or finished medical device products as part of a cross-functional team.
- Implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
- Diagnose and resolve manufacturing and quality system issues.
- Participate in design reviews and pre-validation assessments to ensure processes have adequate and appropriate process controls.
- Lead generation and maintenance of risk management files supporting product development projects, including Risk Management Plans and Reports, Hazard Analyses, Failure Modes and Effects Analyses, Design Trace Matrices, and Post Market Surveillance plans.
- Provide guidance and generate reports involving statistical analysis, including sample size requirements, process capability analysis, regression analysis, tolerance interval analysis, and analysis of variance.
- Support Product and Process Development Engineering optimization activities by guiding Design of Experiments for process parameters and analyzing data.
- Write Process Validation Protocols, analyze data, and write and release Process Validation Reports.
- Interface with customers on design and development responsibilities, quality issues, and supplier-initiated change requests.
- Support hosting external customer and Notified Body audits as applicable.
- Investigate and manage customer field complaints, Supplier Corrective Action Requests, and internal Corrective and Preventive Actions.
- Represent Quality Assurance for Non-Conformance Report dispositions and participate in monthly Oversight Review Boards as needed.
- Provide training on quality system procedures and industry regulations and best practices.
- Technically supervise or coordinate the work of engineers, draftspersons, technicians, and others assisting on specific assignments when required.
- Follow safety and production standard operating procedures.
- Ensure personal and company compliance with Federal, State, local, and company health, safety, and environmental regulations, policies, and procedures.
- Purchase or design equipment that meets company health, safety, and environmental standards.
Confluent Medical Technologies is a medical device contract manufacturer and materials science partner for OEMs, providing design support, prototyping, and full-scale manufacturing. It specializes in Nitinol, with capabilities in Nitinol components, high-precision polymer tubing, biomedical textiles, and balloon catheter systems, all delivered through vertical integration from raw alloy to finished device. The company differentiates itself by owning the supply chain and expanding through acquisitions to cover catheter components, textiles, and polymers, serving neurovascular, structural heart, electrophysiology, and peripheral vascular markets. Its goal is to help medical device OEMs bring safe, high-quality interventional devices to market faster with end-to-end manufacturing and materials science support.
Company Size
1,001-5,000
Company Stage
Debt Financing
Total Funding
$590M
Headquarters
Fremont, California
Founded
1991
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Simplify's Take
What believers are saying
- May 2026 Tom Testa hire strengthens operations, supply chain, and product development.
- January 2026 Filmcast Select expands customizable PTFE and polyimide offerings.
- July 2026 $590 million credit facility funds general corporate purposes and growth.
What critics are saying
- June 2025 Fremont layoff of 102 workers signals restructuring amid expansion.
- Debt load rose after the July 2026 facility, raising refinancing pressure before 2027.
- Concentration in interventional OEMs leaves Confluent exposed if one major customer dual-sources.
What makes Confluent Medical Technologies unique
- Nitinol and polymer vertical integration spans melt, wire, tubing, catheters, and implants.
- Hyderabad wire center doubles output and isolates Fremont for nitinol tubing.
- ATI partnership secures medical nitinol supply and fulfillment from raw material conversion.
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Benefits
Flexible Work Hours
Hybrid Work Options
Remote Work Options
Growth & Insights and Company News
6 month growth
↑ 16%1 year growth
↑ 16%2 year growth
↑ 16%Cahill Gordon & Reindel represented the lead arrangers in Confluent Medical Technologies' $590 million credit facility. The financing comprises a $515 million term B credit facility and a $75 million revolving credit facility. Confluent Medical Technologies will use the proceeds for general corporate purposes. The company specialises in medical device technologies and manufacturing solutions. The transaction demonstrates continued institutional investor appetite for healthcare sector lending despite broader market conditions.
Confluent Medical Technologies has opened a Nitinol Wire Center of Excellence in Hyderabad, India, doubling its nitinol wire output capacity. The 26,000-square-foot facility is ISO 13485 compliant and offers lead times of four weeks for wire diameters from 0.004 to 0.100 inches, with tolerances down to 0.0002 inches. The medical device contract manufacturer has supplied nitinol wire for over 30 years from its Fremont, California location, which will now focus exclusively on nitinol tubing. The new dedicated wire facility represents Confluent's latest investment in its vertically integrated nitinol supply chain, following a recent partnership with industry melter ATI. Confluent specialises in catheter-based devices, implants and nitinol components for medical device manufacturers, operating facilities across the United States, Costa Rica and India.
Confluent Medical Technologies, a medical device contract manufacturer specialising in Nitinol and polymer components, has appointed Tom Testa as chief operating officer, effective 29 April 2026. In his role, Testa will oversee global operations, supply chain, product development and environmental health and safety. Testa joins from Corza Medical, where he served as CEO and CFO. He previously held positions as vice president and general manager at Nordson Medical and president at Vention Medical Advanced Technologies. He holds a bachelor's degree in chemical engineering from New Jersey Institute of Technology and an MBA in finance from New York University. Confluent operates facilities across the United States, Costa Rica and India, providing catheter-based devices and implants to medical device manufacturers.
Confluent Medical Technologies names Tom Testa as Chief Operating Officer. GlobeNewswire | Confluent Medical Technologies Today at 9:30am PDT SCOTTSDALE, Ariz., May 01, 2026 (GLOBE NEWSWIRE) - Confluent Medical Technologies, Inc. ("Confluent"), a leading medical device and materials science contract manufacturer specializing in Nitinol and polymer components, today announced that Tom Testa, has been appointed as Chief Operating Officer ("COO") for the company, effective April 29th, 2026. "We are thrilled to welcome Tom to Confluent," said Dean Schauer, Confluent's President, CEO, and Chairman. "Tom has exceptional experience in all aspects of Executive Leadership in the Medical Device Manufacturing and Development space as well as leadership across multiple, successful, MedTech organizations. As Confluent continues its significant growth, the addition of Tom to our company will further enhance the strength of our industry-leading team." As COO, Mr. Testa's responsibilities will span global operations, and he will oversee Confluent's operations, supply chain, global product development, and environmental health & safety. Mr. Testa joins Confluent from Corza Medical where he served as CEO and CFO. Prio to that, Tom served as Vice President & General Manager of the Nordson Medical business which he joined following the acquisition of the Vention Medical Advanced Technologies Business where he served as President. Tom holds a Bachelor of Science degree in Chemical Engineering from New Jersey Institute of Technology as well as an MBA in Finance from New York University. Commenting on his appointment, Mr. Testa said: "I'm excited to join Confluent at such a pivotal moment in its growth. The company has built a strong reputation as a trusted partner to leading medical device innovators, grounded in its differentiated materials science expertise and vertically integrated manufacturing capabilities. I look forward to working with this talented team to further strengthen operational excellence, expand our global footprint, and help drive the next phase of sustainable growth for our customers and the patients they serve." About Confluent Medical Technologies, Inc.: Confluent Applies Materials Science to MedTech Innovation. Confluent specializes in the expert design, development, and large-scale manufacturing of interventional catheter-based devices and implants. Customers rely on Confluent's expertise in Nitinol material and components, balloon and complex catheters, high-precision polymer tubing, and implantable textiles. With facilities in Fremont and Orange County, California; Warwick, Rhode Island; Windham, Maine; Austin, Texas; Chattanooga, Tennessee; San Jose, Costa Rica; and Hyderabad, India, Confluent has earned the confidence of the leaders in the medical device community through a proven track record of innovative materials science, engineering, and manufacturing. For more information, visit confluentmedical.com. This is a paid placement. For further inquiries, please contact GlobeNewswire directly.
Confluent introduces customizable PTFE and polyimide tubing for medical devices. New program lets OEMs choose specific polymer characteristics for advanced medical applications, moving beyond standard materials. Tubing options in the Filmcast Select program include standard, REACH-compliant glossy and matte, and Ultra polyimides. Confluent Medical Technologies One size almost never fits all, and that's true in the material selection process, as well. To give medical device OEMs more control over the properties of polymer tubing they are sourcing, Confluent Medical Technologies has launched Filmcast Select. The materials customization program allows customers to select key performance attributes of Filmcast PTFE and polyimide tubing, the company said in the Jan. 28 announcement. Material selection process must adapt to medical device complexity. The standard Filmcast polymer tubing process offers little to no customization for device manufacturers, said Confluent, and as procedures become less invasive and devices become smaller and more complex, the one-size-fits-all approach is no longer sufficient. Filmcast Select addresses this shift by enabling OEMs to select Filmcast PTFE and polyimide tubing based on the characteristics that matter most in their applications, including flexibility, strength, durability, surface finish, regulatory compliance, and optical clarity. "Designing next-generation medical devices requires precision at every level, including material selection," said Director of Polymers Technology Shane Wood. "Filmcast Select gives our customers the ability to match material performance to device intent, rather than adapting their designs to standard materials." Wide selection of material properties. Multiple polyimide tubing options are available, including standard, REACH-compliant glossy and matte, and Ultra polyimides. Material properties range from high transparency and reduced friction to stronger bonding. The tensile strength of Ultra polyimide is nearly double that of the standard material in thin-wall designs, added Confluent. The program also features a range of Filmcast PTFE options, including FlexaCast for increased flexibility and elongation, DuraCast for enhanced abrasion resistance, and UltraCast for higher tensile strength in demanding applications. Confluent Medical said it can also work with customer-preferred PTFE dispersions, allowing OEMs to leverage existing biocompatibility data and reduce development time for new or next-generation devices. On show at MD&M West. The company will showcase this new service and related materials expertise at MD&M West in booth 1812. MD&M West is a comprehensive manufacturing-focused trade show and conference for the medical technology, plastics, packaging, and automation sectors. It runs from Feb. 3 to 5, 2026, at the Anaheim Convention Center in Anaheim, CA. Headquartered in Scottsdale, AZ, Confluent operates facilities across the United States as well as in Costa Rica and India. Experience cutting-edge product solutions and global networking at the Plastics Manufacturing Sector, previously Plastec West. Connect with top companies in 3D Printing, Injection Molding, Coatings, Furnishing, and more, as they showcase the latest biocompatible polymers and injection molding innovations.