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Process Development Engineer, Staff (Metrology)

Company: Confluent Medical Technologies INC
Location: Laguna Niguel
Posted on: January 16, 2022

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, Staff to join our Laguna Niguel, CA team. As a uniquely qualified candidate, you will:

  • Be responsible for development, optimization, and validation of medical device production processes.
  • Be a subject matter expert in dimensional and functional metrology tools such as CMM, OMM, GD&T, test and inspection techniques applicable to vascular catheter devices and components.
  • Develop and validate the optimal measurement scheme for variable, attribute, or functional testing.
  • Possess strong foundation in statistical concepts and techniques including gage repeatability and reproducibility, process capability, sampling plans, and confidence intervals.
  • Design and develop fixtures, tools, and hardware with CAD tools for use in metrology tools and applications. Solidworks preferred.
  • Create documentation such as work instructions, test method validation reports, inspection plans, and technical memorandums.
  • Ability to work in a matrix organization and contribute to multiple projects and meet timelines.
  • Firm understanding of relevant standards and calibration requirements is essential. Relevant standards including but not limited to ISO 13485, ISO 17025, ANSI/NCZL Z540-1, -2, -3, and NCSL best practices.
  • Demonstrate leadership qualities such as teamwork, strong oral and written communication with internal and external customers.
  • Familiar with design control for process development and Design development of medical devices.
  • Perform process analysis, improvements and process validation (IQ/OQ/PQ)
  • Proficient in polymers such as Nylon 12, PBAX, Polyurethanes, PET is a plus
  • Plans, schedules, conduct, and coordinates detailed phases of engineering work in part of a major project or in a total project of moderate scope
  • Work in a team environment to accomplish scientific approaches to complex devices development.
  • Design and perform Process Characterization Study's & DOE's, support protocols and reports.Education and Experience:
    • Bachelor's degree in Engineering or equivalent required. Bio-medical device experience preferred.
    • 6-9 years of experience in medical device development
    • Experience in Metrology, Optics, Physics, Engineering or equivalent is desired
    • Hands-on experience with a variety of catheter or balloon production equipment is a plus
    • Formal training or experience in image processing, calibration (mechanical or electrical), optical systems programming a plus.
    • Experience in designing components and assemblies (Solidworks preferred).
    • Experience with statistical software packages (Minitab preferred).
    • Experience in performing audits on Metrology and quality processes desired - along with root cause analysis of technical discrepancies/abnormalities.
    • Greenbelt or higher training is a plus.
    • Authoritative figure in area of expertise.
    • Strong overall knowledge of entire field of work, complex level engineering experience.
    • Attention to detail, professional attitude and a team player

Keywords: Confluent Medical Technologies INC, Laguna Niguel , Process Development Engineer, Staff (Metrology), Engineering , Laguna Niguel, California

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