Sr. Metrology Engineer

AMF Medical is a MedTech start-up, which continues to operate from EPFL’S Innovation Park, after the recently announced acquisition by Tandem Diabetes Care, Inc., a global insulin delivery and diabetes technology company based in San Diego, California.

AMF Medical is developing Sigi™, a next-gen. insulin “patch pump”. This insulin management system will offer better treatment options for people with diabetes, especially Type 1 diabetes young adults and children. You can find out more on our  website . In addition to its uncompromising ergonomics, the pump has better accuracy and faster occlusion detection - among other advantages - than insulin pumps currently available: it received a “Breakthrough Device” Designation by the FDA. This pump is based on a patented microfluidics technology developed in-house over the past 6 years. For detailed info on how Sigi™ answers patient expectations, see  Sigi™ presentation video .

 

GENERAL SUMMARY:

The Sigi™ insulin management system is a high-tech medical product that requires passionate people to make it happen. The Sr. Metrology Engineer will be responsible for defining and validating measurement methods to ensure the quality of the medical device from the verification through to the production phase ensuring patient safety. The Sr. Metrology Engineer will play an interdepartmental role where they will have an active role to foster the importance of the relation between functional specifications and measurement methods to ensure final product quality. They will also be responsible to control the metrology used at vendors and to define and validate test and control measurement systems for the automated production lines.

PRIMARY DUTIES & RESPONSIBILITIES:

• Develops an overall inspection strategy from the product development phase to final manufacturing phase to meet business needs.
• Serves as technical expert for metrology inspection.
• Exercises independent judgment on selection of inspection equipment for use on new and established processes through the process of technical assessment and analysis.
• Interpreting the drawings featuring geometric dimensions to define the measurement techniques considering all the parameters and characteristics of the inspection, including the accuracy and measurement uncertainty.
• Writes and edits programs for programmable inspection equipment utilized in inspection/manufacturing
• Hands-on for initial incoming inspection until handover to technical staff.
• Establish measurement protocols and validate the methods.
• Training of QA/Manufacturing personnel to execute measurement method/equipment.
• Maintenance and calibration of instrument Standards
• Review of the metrology used at suppliers.
• Able to lead technical discussions and corrective actions on non-conformities with the suppliers.
• Lead the implementation and validation of control systems (placement, dimension, tightness, vision, …) on the automated manufacturing lines.
• Participates in design reviews on cross-functional teams to ensure that conformance to specifications, inspect ability, reliability, and quality system objectives are met.
• Work in close collaboration with all departments (Product Engineering, Software, Quality, Industrialization, Production, Test, ...) for the successful implementation of the right measurement techniques and strategy.
• Liaise with the broader Tandem teams.
• Confirms completion of required training plan before assuming job responsibilities.
• Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.
• Other responsibilities as assigned.

 

KEY SKILLS & TEMPERAMENTS:

• Excellent organizational and prioritization skills to manage multiple projects in parallel.
• Knowledge on international standards for measurement and test methods.
• Experience in defining, developing, and validating measurement methods.
• Proven track record of successful project delivery within a structured product development framework.
• Strong statistical background and knowledge on six sigma methodology.
• IQ/OQ/PQ validation process knowledge.
• Familiar with statistical analysis software.
• Skills in measurement equipment programming.
• Demonstrates highly proficient knowledge of Engineering policies, principles and best practices.
• Ability to work independently to identify potential quality issues and implement solutions.
• Basic understanding of mechanical drawings & specifications including geometric dimensioning and tolerances (GD&T).
• Able to recognize non-conformances from accepted and documented practices.
• Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization.
• Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.
• Skilled at creating a cooperative team environment.
• Able to objectively evaluate situations and make recommendations for changes in light of overall project demands.
• Adept at seeing change as an opportunity to improve business performance and campaigning for it when necessary.
• Ability to effectively use MS Office suite (Word, Excel, Outlook) and other applicable software packages.
• Fluency in English (C1 proficiency) and French, German is a plus.

 

EDUCATION, TRAINING & EXPERIENCE:

• Master’s degree in Engineering, preferably Mechanical or Micro-Engineering or the equivalent education and applicable work experience.
• 8 years of professional experience.
• Experience with development within an ISO 13485 certified eQMS, or another similar regulated environment.
• Previous involvement in the development of a Class II or III electromechanical medical device, a plus.
• Experience deploying medical device development projects from pre-series to market approval, a plus.
• Experience with FDA validation of medical devices, a plus.

 

ORGANIZATIONAL RELATIONSHIPS:

• Reports to the Director, Manufacturing Engineering.

 

WE OFFER:

• A high-tech and innovative environment in Medtech, part of a leading global diabetes technology company.
• Excellent working conditions, autonomy, being part of a motivated and highly qualified team.
• Very interesting and stimulating work in an innovative field with high potential.
• A pleasant environment within the EPFL Innovation Park, with possibility to benefit from the campus infrastructure.