Process Development Engineer Jobs in Irvine, CA (NOW HIRING)

Salary Range:
$110,300.00 - $183,800.00
Job Description:
Confluent Medical Technologies is a financially healthy and rapidly growing medical device company whose employees are passionate about providing life-saving solutions to our customers through a collaborative and high-impact work environment. Our environment reflects a culture of growth, leadership, and innovation in which our employees can directly impact the world by doing work that truly matters.
We're looking for a Process Development Engineer, Sr. 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 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
• Develop and design new process parameters, tooling, and methods for 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.
• 9-12 years of experience in medical device development
• Authoritative figure in area of expertise including 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
• Ability to work independently
• Leadership skills
• Problem solving skills
• Attention to detail, professional attitude, team player
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 and tubing, balloon expandable stents and catheters, complex catheters, biomedical textiles, and high precision polymer tubing. 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 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.