Process Development Engineer II
Company: Confluent Medical Technologies INC
Location: Laguna Niguel
Posted on: November 23, 2022
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 II to join the
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 and fixture design and qualification used for
manufacturing medical devices and components. Must be able to
accomplish broad and complex assignments. May provide technical
guidance to lower-level personnel.
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
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
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.
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
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 performing design reviews and pre-validation
assessments to ensure the safe and environmentally sound start-up
of new processes. Preferred Qualifications: Strong in SolidWorks or
AutoCad, Mechanical Acumen and Hands-On
Hands-on experience with a variety of catheter/balloon production
equipment such as: blow molding equipment, hot air systems,
die-bonders, ovens, UV adhesive light welders, laser welders, and
Familiarity with basic hand tools and machine setups. Ability to
actively participate and supervise the set up and operation of
specialized processing equipment.
Good understanding of materials typical to catheter production:
Pebax, Nylon, Polyurethanes, PEEK, PTFE, FEP, Stainless steel,
NiTi, CA and UV adhesives, etc. Education and Experience: BS degree
3 - 6 years of experience in Material Science, Optics, Physics,
Engineering or equivalent
Excellent written and oral communication skills are required
Experience in performing audits on manufacturing and technical
processes desired - along with root cause analysis of technical
Familiarization with method development, calibration, measurement
development, laboratory auditing and root cause and Gage R&R
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 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
Keywords: Confluent Medical Technologies INC, Laguna Niguel , Process Development Engineer II, Engineering , Laguna Niguel, California
Didn't find what you're looking for? Search again!