Manager, Engineering (Metrology)

Confluent Medical Technologies•Fremont, CA

6d•Onsite

About The Position

Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking 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 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 seeking a Metrology Quality Manager to join our dynamic team of industry leading experts. This Engineering Manager will assist in maintaining a laboratory quality management system that is registered to ISO 13485, and in some scope accredited to ISO 17025. This position will determine the direction forward in application of the most cost effective, suitable measurement technologies for Nitinol medical devices and implants for the entire company, including monitoring and adoption of the most current technologies to the tasks.

Requirements

BS degree in a relevant discipline and 8 or more years of related engineering and management experience.
MS degree and 5 or more years of related experience.
Ph.D. and 3 or more years of related experience
Strong overall knowledge of entire field of work, complex level engineering experience.
Excellent written and oral communication skills are required.

Nice To Haves

2+ years of leadership and people management experience.
Hands-on experience with a variety of optical and laser related equipment including power meters, oscilloscopes, Photodiodes, beam cameras and other relevant diagnostic equipment related to laser characterization.
Formal training and experience with mechanical or electrical calibration a plus.
Experience with image processing and optical systems is preferred.
Experience leading technical teams is preferred.
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 with method development, calibration and testing laboratory auditing and uncertainty development desired.

Responsibilities

Lead and develop a staff of application development engineers and technicians in support of our growing company needs.
Provide guidance and leadership for identification and development of new and improved metrology systems to support new product development projects.
Support instrument development activities for metrology systems, which includes mechanical design, precision motion control implementation, machine vision method development.
Coordinate transfer of new metrology equipment and methods to other manufacturing sites.
Assume role of subject matter expert for metrology systems.
Possess essential knowledge of national and international standards documents to the calibration business. Relevant standards include, but are not limited to: ISO 13485 series, ISO 17025, ANSI/NCSL Z540-1, -2, - 3, and NCSL recommended practices.
Recommend and establish test procedures and methods for specific projects, calibration expectations for those procedures, and review and/or revise procedures currently in use.
Determines accuracy and applicability of measurements.
Assist in training metrology technicians to implement the procedures, along with analyzing inspection, measuring, and test equipment to determine the appropriate applications.
Monitor performance of metrology systems and provide direction for long-term improvements.
Works with a wide variety of gages, instruments and inspection devices including manual/ hand measurement tools as well as vision/ optical systems.
Perform engineering and statistical analyses of the equipment and historical data to determine appropriate calibration intervals to meet reliability goals – analyzing, evaluating, and documenting measurement uncertainty to ensure best practices are in use.
Be familiar with analyzing requirements for measurement standards and make recommendations for purchase.
Communicate with other departments in the company, along with equipment manufacturers and vendors, regarding test, measurement and calibration issues.