Development Engineer - Quality

Novostia is a start-up company developing a unique heart valve prosthesis with the mission to improve the quality of life for patients suffering from heart valve disease, especially children and young patients.

Take up new challenges and join our innovative, dynamic, and passionate team!

Your main role

Reporting to the Product and Process Development Manager, your principal duties and responsibilities will be to:

  • Actively contribute to the industrialization activities.
  • Support the development and implementation of quality and regulatory documentation related to the technology and to the manufacturing process (Validation Master Plan, Quality Plan).
  • Interface with all partners involved in the development, manufacturing, quality, and regulatory activities.
  • Support Design Risk Management Activities (dFMEA per ISO 14971), including Human Factors assessment.
  • Manage Process Risk activities at Suppliers (pFMEA).
  • Develop and implement methods and procedures for inspecting, testing, and evaluating the performance of product.
  • Identify and control critical quality attributes.
  • Establish and maintain product traceability.
  • Develop, lead and coordinate CAPA and Non-Conformities action plan.
  • Provide statistical data /trends analysis on CAPA, Non-Conformities and other quality metrics.
  • Participate in Suppliers audits.
  • Support quality system improvements activities.

Your profile

  • Min. Bachelor’s degree in engineering (biomedical, mechanics, micro-technologies)
  • Min. 5 years’ experience as an engineer working with, ideally Class III implantable medical devices and in the cardiovascular industry – Senior welcome
  • Proven experience with product development and manufacturing activities
  • Consistent background and knowledge of the medical device industry regulations
  • Rigor, attention to details, dedication, self-driven, and sense of responsibility
  • Ability and willingness to work in start-up environment
  • Excellent communication skills in English (C1 level) and French (German is a plus)

Additional information

  • Starting date: As soon as possible, ideally January 2022
  • Localisation: Lausanne
  • Activity rate: 80% to discuss
  • Applicant must be Swiss or holder of a valid work permit in Switzerland


Send your motivation pitch and your CV directly to Christophe at the following email address > c.aubert [at] novostia.com