Salary Range:
$122,625.00 - $204,375.00
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 moderate size, diversity of technologies, and broad material science capabilities provide an environment in which our employees can develop broad skill sets and directly influence product development and manufacturing outcomes.
The Senior Staff Metrology Process Development Engineer will work with our Fremont, CA new products development team! This engineer will be responsible for developing test and inspection methods of medical devices manufactured in a facility that is registered to ISO 13485. This engineer will collaborate in a matrix organization to develop and deliver metrology solutions on-time.
Responsibilities:
-
Be a subject matter expert in Metrology, testing and inspection techniques applicable to vascular devices and components
-
Understand the fundamentals of optical and other measurement techniques but also possess solid foundation to contribute to the development of the right measurement requirement scheme for Confluent Medical Technology’s in process and final test and measurement efforts
-
Be able to generate best means to answering dimensional, surface, quality, geometric attribute, defect analysis, functional testing and other measurement requirements
-
Demonstrate best practices in optical and other Metrology techniques with off-the-shelf and in house generated test and measurement tools
-
Ability to work in a matrix organization and contribute to the projects
-
Be highly familiar with multitude of optical and other inspection systems and their limitations
-
Be highly familiar with optical inspection programming schemes and techniques
-
Possess high level of competency in reviewing, designing, and contributing to fixtures, tools, and hardware development efforts along with input into lab instrumentation and possible new technologies
-
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
-
Ability to own and prove leadership qualities
-
Strong engineering background in mechanical engineering, software engineering, and/or optics is highly desirable
-
Ability to work with internal and external customers, demonstrating strong communication skills and goal oriented behavior
-
Project Management skills are highly desirable
-
Possess strong foundation in statistical concepts and techniques including sampling plans, gage repeatability and reproducibility, process capability, and reliability and confidence intervals
Essential Qualities:
-
In-depth knowledge of engineering standards and GD&T principles related to medical device processing to provide accurate interpretation of complex drawings and specifications.
-
Excel in solving complex metrology and testing process development challenges by devising the optimal systems and measurement methods to ensure reliable results for production.
-
Clear and efficient communication in a highly technical environment with both internal and demonstrating a solutions oriented behavior.
-
Capable of performing under the pressure of multiple competing deadlines while maintaining a cooperative and constructive working relationship with colleagues.
Education and Experience:
-
Bachelor’s degree in Engineering or equivalent with minimum of 9 years of experience in Metrology, Optics, Physics, Engineering or equivalent. Advanced degrees are welcome.
-
Formal training and experience in mechanical or electrical calibration a plus.
-
Experience with the following systems: CMM, CAD like Soliworks and Material testing is preferred.
-
Excellent written and oral communication skills are required.
-
Experience in performing audits on Metrology and quality processes desired – along with root cause analysis of technical discrepancies/abnormalities.
-
Experience in preparing laboratory documentation (work instructions, calibration procedures, analysis spreadsheets, reference documents and others) in a variety of formats including Word, Excel and PowerPoint.
-
Familiarization, laboratory auditing and root cause and Gage R&R analysis using statistical software is desired
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.