Director, Electro-Mechanical Engineering
vor 2 Monaten
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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