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 Metrology Engineer II to join our team in Fremont, CA. As a uniquely qualified candidate, you will: Work as part of Confluent's multifunctional Process Development Team responsible for development, optimization, and validation of medical device production processes. Be a subject matter expert in dimensional metrology tools such as CMM, OMM, GD&T, test and inspection techniques applicable to vascular 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. 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 include 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.
Education and Experience:
Bachelor's or Master's degree in Engineering or equivalent required. Bio-medical device experience preferred. Minimum 2 years of experience in Metrology, Optics, Physics, Engineering or equivalent required.
Formal training or experience in image processing, calibration (mechanical or electrical), optical systems programming a plus.
Experience in designing components and assemblies in Solidworks preferred.
Experience in performing audits on Metrology and quality processes desired – along with root cause analysis of technical discrepancies/abnormalities.
Confluent Medical Technologies offers very competitive compensation and benefits and is proud to have a distinguished reputation across Silicon Valley and throughout the medical device industry around the world! We welcome eager and ambitious team players to apply! There is no better time to join Confluent.
Qualified candidates will be contacted. No phone, fax or email inquiries from potential applicants, external recruiters or other interested parties, please. We regret that we are unable to sponsor employment visas or consider individuals on a time-limited visa status for this position. Confluent Medical Technologies is an equal opportunity employer.
