Mechanical Engineer specialized in injection molding for medical devices

Besançon, France

Aspivix is a medical device company in women’s health, based in Switzerland with a C-Corporation in California, and a new entity in France, developing next-generation devices for gynecology. 


Our flagship product, Carevix™, is the world’s first suction cervical stabilizer clinically proven to reduce pain and bleeding associated with transcervical procedures commonly performed in gynecology, including Intra Uterine Device insertion, hysteroscopy, cervical biopsies, fertility treatments, and more.


Are you ready to join a dynamic environment and an amazing team passionate about improving women’s healthcare for millions worldwide?We are excited for you to join our team and contribute your ideas and experience to sustainably advance women’s healthcare

 

Mechanical design
Injection molding
Autonomy
Technical documentation

Your Responsibilities & Missions

Product Development

  • Lead the mechanical development of the next generation of instrument and contribute to the ASPIVIX’s roadmap and products portfolio. Actively contribute to new mechanical designs and design changes.
  • Lead the industrialization phase for a MedTech Class Is device until product launch in collaboration with the Chief Technical Officer/Project Manager.
  • Drive activities requiring mechanical changes to sustain the product after launch.
  • Translate market and user requirements into technical solutions, review and actively contribute to system requirements, and identify non-functional requirements early in the development process.


Regulatory Compliance

  • Develop and update technical documentation from user requirement to verification and validation.
  • Ensure detailed documentation of designs in compliance with Quality Management System and regulatory standards (MDR, ISO 13485, V-model, US FDA 21 CFR part 800) and be responsible for mechanical risk management.
  • Develop and maintain technical files according to SOPs and international standards (ISO/FDA, DHF-DMR-DHR).


Supplier Management

  • Manage external suppliers (contract manufacturing organization - CMO, Regulatory, etc.).
  • Launch and lead new R&D project(s) with academic institutions.


Documentation & Reporting

  • Actively collaborate with the development team, RA&QA team, external suppliers, and manufacturing.
  • Identify Intellectual Property (IP) opportunities and strengthen company IP.


About You

Responsibilities

  • Product Development
  • Regulatory Compliance
  • Supplier Management
  • Documentation & Reporting

Must Have

  • Higher Technician Diploma in Plastics Industries (BTS), or Bachelor/Master in Mechanical engineering or equivalent qualification
  • At least 3 years working experience as a professional developer in medical devices industry
  • At least 3 years experience for plastic injection molding, mold flow simulations, molds manufacturing and assembly methods
  • Excellent knowledge of CAD Design and tools such as i.e. Solidworks, or equivalent, 3D and 2D drawings, assembly and stacking tolerances
  • Industrialization know-how IQ/OQ/PQ, verification and validation
  • Experience in Product Risk management and Usability engineering, D-FMEA, P-FMEA
  • Strong analytical skills and process-oriented work style with a structured, independent approach to work and focus on getting things done

Nice to have

  • Experienced with rapid prototyping methods and limitations
  • Experience in (bio-based) polymers choices and characterizations is a plus
  • Excellent written and verbal communication skills with the ability to adjust to the audience
  • Additional languages
  • Willingness to work flexibly, in an interdisciplinary and international environment
  • Willingness to contribute to women’s health changes and innovation

What's great in the job?


  • The opportunity to make a meaningful impact in advancing women's healthcare.
  • A dynamic work environment with a flat hierarchy and short decision-making processes.
  • Versatility to develop and expand your skills in an agile company.
  • Great team of smart people, in a friendly and open culture
  • No dumb managers, no stupid tools to use, no rigid working hours
  • No waste of time in enterprise processes, real responsibilities and autonomy
  • Real responsibilities and challenges in a fast evolving company


Our first medical device

Carevix

ASPIVIX Story

Do you want to know more about us ?