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

Beschreibung

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