Director, Electro-Mechanical Engineering - Saint-Sulpice, Schweiz - Tandem Diabetes Care Switzerland Sàrl

Beschreibung

Tandem Diabetes Care Switzerland Sàrl, a subsidiary of Tandem Diabetes Care, Inc., is a MedTech start-up located in EPFL's Innovation Park in Lausanne, Switzerland. Tandem Diabetes Care, Inc., is a global insulin delivery and diabetes technology company based in San Diego, California. Together we are creating new possibilities for people living with diabetes, their loved ones, and the healthcare providers through a positively different experience.

Director, Electro-Mechanical Engineering

INNOVATE EVERYDAY:

Tandem Diabetes Care Switzerland is developing SigiTM, a next-generation insulin "patch pump" that will offer additional treatment options for people with diabetes. This pump is based on a patented microfluidics technology developed in-house over the past 6 years. You can find out more about Sigi here.

A DAY IN THE LIFE:

The Director, Electro-Mechanical Engineering is responsible for the electro-mechanical product development, testing, verification and validation of the SigiTM insulin patch pump. This role sets the direction and leads the Mechanical & Electrical Engineering teams responsible for developing an exceptional product through regulatory approval, and transfer to manufacturing.

Working from Tandem Diabetes Care Switzerland's office onsite in Switzerland, you'll....

• Play an active leadership role in the development and design of high-quality electro-mechanical components, systems and architecture for the SigiTM insulin patch pump system.
• Play an active leadership role in the design of the SigiTM patch pump system including product functionality, features and accessories; in close collaboration with Director, Software Engineering, and under the direction of Tandem Switzerland senior management.
• Ensure that all product requirements are being met by the design and test strategy during the product development process.
• Provide leadership for Design Controls compliance and maintenance of Design History Files.
• Play an active leadership role in defining approaches for system validation and design
• Oversee day to day operations of the Mechanical Engineering and Electrical Engineering teams to include:
  • Provide guidance and mentorship on task/goal prioritization to team leaders when necessary.
  • Motivate and manage staff to work closely with other teams.
  • Manage selection, development, performance appraisal, merit recommendation, and promotion of department staff.
  • Facilitate the development, communication, and evaluation of goals for the group on an annual basis.
  • Direct long and short-term planning for the department including headcount, budgeting, training, and systems requirements.
• Manage planning for the design development, modification and evaluation of parts, components, mechanical systems, equipment and packaging, electrical systems, sensing systems or optical systems; in collaboration with the Program Management team.
• Work in close collaboration with the Director, Software Engineering to ensure an integrated and overall coherent user experience.
• Work closely with the Quality, Regulatory, and Clinical teams at Tandem USA and Tandem Switzerland to:
  • build an ISO 13485 environment adapted for Class 2B product development.
  • support to Quality, Regulatory and Clinical teams in conducting V&V and clinical studies.
  • provide leadership for Design Controls compliance and maintenance of Design History Files.
  • Contribute to and establish product development policies such as the Quality Management System and ensure adherence to it during the design and development processes.
• Identify and manage suppliers and vendors required for the product development process.
• Manage projects and activities in a multiple project environment with high demand schedules for direct staff, subcontractors, and outsourced services; in collaboration with the Program Management team.
• Provide regular project planning and implementation updates to the Program Management and senior leadership teams.
• Work on issues that impact design/selling success or address future concepts, products or technologies. Often serve as consultant to executive management.
• Negotiate with other departments as needed and consider company-wide impacts in decision making.
• Ensure department staff is properly trained, per designated training plan, before assuming job responsibilities.
• Ensure department's adherence to company policies, including privacy/GDPR, as well as other legal and regulatory directives.

YOU'RE AWESOME AT:

• Demonstrated experience in electro-mechanical Class II/III medical device project management, from development to transfer to manufacturing.
• Strong understanding of medical devices development process including the regulatory approval process.
• Talented engineer.
• Passionate about enhancing performance & reliability of insulin patch pumps and committed to finding the best solutions to enable the best possible user experience.
• Deep knowledge and experience with federal and other regulations, e.g. QSRs, ISO 14971, IEC 60601 series.
• Strong team player with senior management and all departments to ensure smooth collaboration.
• Innovative mindset with a results orientation and proactive attitude.
• Strong organizational and time management skills.
• Demonstrated ability to work in a fast-paced environment managing multiple priorities.
• Experience with writing requirements and technical specifications.
• Experience with mechanical and electronical design strongly preferred.
• Very knowledgeable with Good Documentation Practices (GDP) methodology.
• Advanced integration experience in a manufacturing environment, to assist with the transfer of testing methodology to manufacturing.
• Proficient with SolidWorks and/or Altium, utility software, and testing and tracking software, a plus.
• Skilled at influencing senior level leaders regarding matters of significance to the organization.
• Adept at creating and communicating a clear vision and expectations among team members effectively aligning resources to achieve functional area goals.
• Strong sense of personal accountability to deliver on-time, within objectives and budget products that exceed expectations.
• Excellent written and verbal communication skills including strong presentation skills.
• Fluent in English. Fluent in French preferred.

YOU'LL NEED

• Master's degree in Mechanical Engineering, Biomedical Engineering or related field or equivalent combination of education and applicable job experience; Ph.D. a plus.
• 10 plus years of experience in Medical Device electro-mechanical Engineering in a product development environment.
• 8 plus years of experience in Management building and leading teams.
• 10 plus years of experience in Product life cycle from concept to market approval and commercialization.
• Knowledge and understanding of the diabetes industry preferred.

WHAT'S IN IT FOR YOU?

In addition to innovative technology, we have a culture that fosters the idea that the happiest people are the most productive people. Not only do we hire forward-thinking achievers to join our workforce; we reward, develop, and retain them too. We offer:

• A high-tech and innovative environment in MedTech
• Excellent working conditions, autonomy, being part of a motivated and highly qualified team
• Interesting and stimulating work in an innovative field with high potential
• Pleasant environment within the EPFL Innovation Park, with possibility to benefit from the campus infrastructure