Process Development Engineer I

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 are looking for a Process Development Engineer I to join our Laguna Niguel, CA team. As a uniquely qualified candidate, you will:
 

• Responsible for process identification, parameter optimization, proof of concept testing, technology improvements, and process implementation.   
• Responsible for tool, extrusion, and fixture design and qualification used for manufacturing medical devices and components. Must be able to accomplish broad and complex assignments.  Capable of providing technical guidance to lower level personnel.
• Responsible for developing processing parameters for medical devices and components.
• Responsible for screening and optimization of process parameters to achieve robust and stable processes and maximize yields, efficiencies and process capabilities.   
• Plans and conducts work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria.
• Design and perform Process Characterization Study’s & DOE’s, support protocols and reports.  
• Have a firm understanding of validation strategy (IQ/OQ/PQ), support protocols and reports.   Independently performs most assignments with instructions as to the general results expected.
• Perform data analysis to determine product performance and capability.
• Responsible for generating Work Instruction, Workmanship Standards, Engineering Memos and other related documents.
• Understand and execute Test Methods as well as develop inspection techniques for devices or components that cannot be measured using traditional methods.
• Works on problems and projects of moderate scope where analysis of situation or data requires a review of identifiable factors.  Selects techniques to solve complex problems and make sound design recommendations.
• Exercises judgment within defined procedures and practices to determine appropriate action.  Demonstrates full use and application of standard principles, theories, concepts and techniques.  Selects design direction or modifications of components of systems.
• Work with project managers to create a project plan and timeline.
• Receives technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects.
• Plans, schedules, conduct, and coordinates detailed phases of engineering work in part of a major project or in a total project of moderate scope.
• Performs work that involves conventional engineering practice but may include a variety of complex features such as conflicting design requirements, unsuitability of conventional materials, and difficult coordination requirements.
• Practices company safety, quality policies and procedures, actively requires conformance.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.
• Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.

Preferred Qualifications:

• Strong in SolidWorks, Mechanical Acumen and Hands on.
• Experience using Minitab.
• Experience and understanding of balloon blow molding process, process parameters, bi-axial orientation and stress/strain of polymer tubing.
• Experience in blow molding material and tooling design.
• Read and understand technical drawings/requirements, Work Instructions, and Workmanship Standards.
• Good understanding of materials typical to balloon design and production: Pebax, Nylon, Polyurethanes, Resin Compounds, PEEK, PTFE, FEP, CA and UV adhesives, Stainless steel, NiTi, etc.  

Education and Experience:

• BS degree in engineering .
• 0 - 3 years of experience in Metrology, Physics, Engineering or equivalent.
• Experience working in a regulated environment.
• Formal training and experience with mechanical or electrical calibration a plus.
• Excellent written and oral communication skills are required.
• Experience in root cause analysis of technical discrepancies/abnormalities.
• Experience in preparing laboratory documentation (work instructions, calibration procedures, analysis spreadsheet, reference documents and others) in a variety of formats including Word, Excel and PowerPoint.
• Familiarization with method development, calibration, measurement development, laboratory auditing and root cause and Gage R&R analysis desired.

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.