Process Development Engineer, Staff

Confluent Medical; Laguna Niguel, Northern (CA, KY); Hybrid; USD 91,000 - 151,000; Full time

Job summary

Confluent Medical Technologies in Laguna Niguel, CA is seeking a Staff Process Development Engineer to advance catheter, balloon and extrusion development. You will lead process analysis, validation (IQ/OQ/PQ), and design of robust processes while collaborating with multi-disciplinary teams across facilities.

The role requires 6+ years in medical device development, strong polymer science knowledge, and proficiency in AutoCAD/SolidWorks.

Qualifications

• 6+ years in medical device development.
• Authoritative in catheter, balloon, extrusion.
• Experience with polymer testing methods (FTIR, DSC, MA).
• Design control documents for medical devices.

Responsibilities

• Lead catheter, balloon, extrusion development projects.
• Perform process analysis, IQ/OQ/PQ, and validation.
• Develop and execute validation protocols.
• Create reports and communicate findings to teams.
• Collaborate with cross-functional teams across sites.
• Design process parameters, tooling, and methods for devices.
• Drive NPI, cost reduction, and revenue projects.
• Mentor junior engineers and perform design reviews.

Skills

Catheter development

Balloon development

Process validation

DOE

Report writing

Leadership

Cross-functional teamwork

Polymer science

Troubleshooting

Problem solving

Education

B.S. or M.S. in Mechanical or Biomedical/Bio Engineering

Tools

AutoCAD

SolidWorks

Minitab

FTIR

DSC

Job description

Salary Range: $90,800.00 - $151,300.00

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’re looking for a Process Development Engineer, Staff to join our team in beautiful Laguna Niguel, CA. As a uniquely qualified candidate, you will:

• Work in a team environment to accomplish scientific approaches to catheter, extrusion and balloon development
• Perform process analysis, improvements and process validation (IQ/OQ/PQ)
• Develop and execute validation protocols
• Create reports and/or other communications to effectively report engineering findings
• Work with cross-functional teams to become a pivotal member of Confluent engineering team
• Develop and design new process parameters, tooling, and methods for catheters, balloons and extrusion manufacturing
• Lead new product introduction, cost reduction, and revenue generating projects
• Potentially support engineering projects or cross-train in the area of polymer extrusion
• 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
• Maintain cleanliness of the work environment.
• Mentor less experienced engineers
• Perform design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes
• Plan, schedule, conduct, and coordinate detailed phases of engineering work in part of a major project or in a total project of moderate scope

Education and Experience

• Bachelor or Masters of Science in Mechanical or Bio Engineering.
• 6+ years of experience in medical device development
• Authoritative figure in area of expertise including catheter, balloon and extrusion of medical devices
• Experience with polymer testing methodologies such including FTIR, DSC, MA
• Proficient in medical grade polymers such as Nylon 12, PBAX, Polyurethanes, PET with knowledge and experience in polymer science
• Experience with authorship of design control documents for medical devices
• Proficient in AutoCAD to create drawings for balloons, extrusion, and tooling required in balloon development
• Ability to work independently and support multi-sites
• Strong Solidworks and AutoCAD skills
• Strong Minitab experience
• Greenbelt or higher training is a plus
• Hands-on experience with a variety of catheters, balloons, and extrusion production equipment
• Strong understanding of biomaterials typical to balloons: Pebax, Nylon, Polyurethanes, and PET
• 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 including but not limited to thermal bonding and swagging
• Ability to work independently
• Leadership skills
• Problem solving skills
• 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.

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.