Director, Electro-Mechanical Engineering

vor 4 Wochen

StSulpice VD, Schweiz Tandem Diabetes Care Switzerland Sàrl Vollzeit

INNOVATE EVERYDAY: 

Tandem Diabetes Care Switzerland is developing Sigi™, 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 Sigi™ 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 Sigi™ insulin patch pump system.
  • Play an active leadership role in the design of the Sigi™ 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 

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