Process Development Engineer, Senior Staff

Salary Range:

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’re looking for a Process Development Engineer, Sr. Staff to join our Laguna Niguel, CA team.

As a uniquely qualified candidate, you will:
 Work in a team environment to accomplish scientific approaches to extrusion and balloon development.
 Proficient in medical grade polymers such as Nylon 12, PBAX, Polyurethanes, PET with knowledge and experience in polymer science
 Experience with polymer testing methodologies such including FTIR, DSC, MA
 Perform process analysis, improvements and process validation (IQ/OQ/PQ)
 Developing and executing validation protocols
 Create reports and/or other communications to effectively report engineering findings.
 Works with cross-functional teams to become a pivotal member of Confluent engineering.
 Position may be assigned to support engineering projects or cross-train in the area of polymer extrusion.
 Develop and design new process parameters, tooling, and methods for extrusion manufacturing.
 Lead new product introduction, cost reduction, and revenue generating projects
 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
 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.
 Able to work independently and support multi-sites
 Maintain cleanliness of the work environment.
 Mentor less experienced engineers.
 Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
 Plans, schedules, conduct, and coordinates 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.
 9-12 years of experience in medical device development
 Authoritative figure in area of expertise including extrusion of medical devices
 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
 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.