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

Job Description:

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.

Only qualified candidates will be contacted.