Mechanical Engineering Team Leader – Medical Device

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 Mechanical Engineering Team Leader is responsible for the development, testing, verification and validation of all mechanical parts of AMF Medical's insulin patch pump. The key goal is to successfully transfer the design to manufacturing after demonstration of reliability. She/he sets the direction and leads daily the mechanical engineering teams from pre-series to regulatory approval.

 

Key Skills and Temperament

• Recognized as a leader, provides direction for the development of all mechanical functions.
• Recognized experience in design for manufacturing and transfer into a manufacturing environment.
• Real talent in micromechanical design.
• Autonomous and proactive, with a team player mindset.

 

Primary Duties & Responsibilities

• Responsible for enhancing the reliability of the patch pump mechanical systems.
• Work in close collaboration with the Electrical Engineering team.
• Ensure successful and timely execution toward company goals, in close collaboration with the Electrical Engineering, Software Engineering, Manufacturing and QA/RA teams.
• Oversee the day-to-day operations of the Mechanical Engineering team including:

            - Motivate and manage staff: manage selection, development, performance evaluation, merit recommendation and promotion of team members.

            - Manage the planning of the design, development, modification and evaluation of parts, components, mechanical systems, equipment and packaging.

            - Work closely with the Electrical Engineering Team Leader to ensure integrated and overall consistent product functions.

            - Identify and manage suppliers and vendors required for the product development process.

• Participate to micro-mechanical systems risk analysis (both design and process FMEAs).

 

Education, Training and Experience

• Master's degree in microengineering, mechanics, or equivalent.
• 15 years of combined experience in medical device industry or another regulated field.
• Fluent in English and French preferred, German an asset.
• Experience in leading teams.
• Experience with product lifecycle from pre-series to market follow-up.
• Expert in reliable mechanical design.
• Strong experience in the design and development of mechanical medical devices, or automotive systems, from pre-series to production and regulatory approval.
• Demonstrated experience in industrialization and manufacturing processes capability.
• Excellent knowledge of micro-mechanical assembly tolerancing.
• Understanding of the mechanical medical device development process, including the regulatory approval process. Or experience in another highly regulated environment.
• Advanced knowledge of Solidworks, use of surfaces and simulation tools an asset.
• Strong organizational and time management skills.
• Proven ability to work in a fast-paced, multiple priority environment.
• Good knowledge of production techniques and automation is an asset.
• Good knowledge of plastic injection, is an asset.

 

Organizational Relationships

• Reports to the Sr. Director, Product Development 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.