Engineering Project Manager – 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 Sigi™ insulin management system is composed of various parts and components, combining mechanics, electronics, and software. A high-tech medical product that requires passionate people to make it happen. Sigi's development path requires strong sub-project management, and the missions will evolve over time. The mission of the Engineering Project Manager will be to assist the product engineering team with the responsibility of coordinating, orchestrating, and documenting specific sub-projects. The candidate will play an interdepartmental role where he/she will for example have an active role in quality documentation (change request management...). The candidate should also be able to work independently and be willing to work on coordination tasks on his/her own. A hands-on approach and high technical skills are required.

 

PRIMARY DUTIES & RESPONSIBILITIES:

• Plan, contribute to, document and follow assigned sub-projects.
• Identify and resolve technical issues that may arise during the project.
• Support and coordinate team tasks to achieve assigned multiple sub-project objectives.
• Work in close collaboration with other departments (Software, Quality, Industrialization, Production, Test, ...) for the successful completion of the sub-projects assigned.
• Organize the development of product subparts with detailed attention to integration and feasibility at the complete system level.
• Create or organize required documentation (design history file) as needed, including an active role in quality documentation (change request management for instance)
• Oversee and monitor the progress of the project, making adjustments to the project plan as necessary to ensure project success.
• Create and provide regular verbal and written project updates. Including reports for management detailing project status, risks and recommendations.
• Serve as the point of contact for all engineering questions posed by project team members and other departments.
• Manage the budget for assigned sub-projects, ensuring that all costs remain within approved limits.
• Review and approve project documentation prepared by other members of the engineering team.
• Participate in the development of electromechanical subsystems and perform engineering tasks.
• Independently manage R&D vendors for sub-projects.

 

KEY SKILLS AND TEMPERAMENT:

• Passionate about the efficient development of medical device subsystems and the tools that support it.
• High multitasking competence.
• Structured technical mind with strong attention to detail, and prompt to document activities.
• Highly satisfied with being responsible for the timely completion of sub-projects that exceed expectations.
• Keen to work on coordination, planning and documentation topics as well as technical issues.
• Talented in interdepartmental work and smart coordination of complex sub-projects with internal and external stakeholders.

 

EDUCATION, TRAINING & EXPERIENCE:

• Master's degree in micro engineering, or equivalent.
• Excellent ability to implement complex electromechanical development.
• Excellent organizational and prioritization skills to manage multiple projects in parallel.
• Strong knowledge of Asana or similar project planning software.
• Good knowledge of medical device development.
• Fluency in English and French, German is a plus.
• Proven ability to work in a fast-paced start-up environment in a small team environment.
• Excellent team-player, very good ability to work independently.
• Good communication and documentation skills.
• Ability to take initiative, learn quickly, be enthusiastic and curious.
• Ability to document efficiently and rigorously all activities.
• 5 years of professional experience.
• Experience with development within an ISO 13485 certified eQMS, or other similar regulated environment.
• Experience in structured sub-part development of complex products (requirements-based engineering, detailed design, FMEA, formal verification, release process, etc.).
• Previous involvement in the development of a Class II or III electromechanical medical device, a plus.
• Proven track record of successful project delivery.
• 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 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.