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Sr. Systems Engineer Hardware

bewerten
Bewertung abgegeben
29.02.2024 100% Festanstellung
Tandem Diabetes Care Switzerland Sàrl

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.

Sr. Systems Engineer Hardware

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:

This position entails supporting system engineering activities within new development projects at Tandem Diabetes Care Switzerland, which is working on Sigi, the new-generation tubeless insulin patch pump for people with diabetes. The Sr. Systems Engineer Hardware (HW), will work cross-functionally to enhance the definition, design, and development of Tandem’s products with focus on mechanics and electronics. Specifically, the Sr. Systems Engineer HW will define and/or contribute to the development of system level requirements, interface definitions and subsystem design, in close collaboration with the Systems Engineering SW function, under the guidance of the R&D leadership.

  • Develops, documents, maintains, and communicates system and subsystem requirements and design, in coordination with various stakeholders such as Engineering, Product Management and Quality Assurance.
  • Contributes to the development and maintenance of inter-system interface specifications and contracts, considering cross-subsystem impacts.
  • Contributes to the risk management process and derives risk mitigation requirements.
  • Provides system expertise to support on-market-products technical support troubleshooting, failure analysis, and triage of system level issues.
  • Contributes to system level performance requirements and tests.
  • Maintains tight collaboration with the teams responsible for product V&V, writes and reviews test plans and protocols, and helps triage issues uncovered during testing activities.
  • Works closely with the HW (mechanics and electronics) development teams to flow down the system and subsystem requirements and assist with establishing traceability.
  • Traces system and subsystem requirements to the user and business needs defined for the product.
  • Serves as a key member of a cross-functional project team consisting of product managers, test/quality engineers, development engineers, manufacturing, and other stakeholders.
  • Identifies and document system interdependencies to mitigate hazards, failure modes, and other risks.
  • Maintains system level architectural diagrams and requirements on an ongoing basis.
  • Supports other departments as needed and considers project-wide impacts in decision making.
  • Develops system designs that meet predefined business needs related to demand, cost, and performance.
  • Mentors more junior system engineers in the performance of their duties.
  • Ensures compliance with company policies and product applicable standard, Usability, and other legal and regulatory requirements.
  • Other responsibilities as assigned.

YOU’RE AWESOME AT:

1. Knowledge, skills & abilities:

  • Demonstrated capability in Systems Engineering practices such as requirements management, design trade-off and cost-benefit analysis, hazard analysis and risk assessments.
  • Ability to dive into the details and analyze different cross functional inputs to produce suitable solutions.
  • Ability to work independently and deliver a high-quality work product without close supervision.
  • Ability to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.
  • Ability to effectively convey information related to work product and lead group discussions.
  • Familiarity with one or more of the following: ISO 13845, ISO 14971, IEC 62304, ISO 62366, 21 CFR part 820.30-Design Controls, HIPAA and/or GDPR, preferred.
  • Fluency in English required; fluency in French preferred.

2. Minimum certifications/educational level:

  • Master of Science or equivalent degree in Systems Engineering, Electrical Engineering, Mechanical Engineering, or Biomedical Engineering required.
  • Advanced coursework, or professional licensing in related field desirable.

3. Minimum experience:

  • 5 years’ experience working as a Systems Engineer or with systems engineering responsibilities in a multidisciplinary project team environment.
  • 3 years’ experience working in a regulated industry; Medical Device industry preferred.
  • Experience with requirements management systems (e.g., JAMA, DNG)

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

Kontakt

Déborah Lavabre


Über die Firma
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