Mechanical Engineer Specialized in Injection Molding for Medical Devices

Aspivix is a medical device company in women’s health, based in Switzerland with a C-Corporation in California, and a new center in Besançon 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 IUD 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.

**Responsibilities**:
**Product Development**
- Lead the mechanical development of the next generation of instruments and contribute to the ASPIVIX’s roadmap and product 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 requirements 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**:

- Higher Technician Diploma in Plastics Industries (BTS), or Bachelor/Master in Mechanical engineering or equivalent qualification.
- At least 3 years of working experience as a professional developer in the medical devices industry
- At least 3 years of experience in plastic injection molding, mold flow simulations, molds manufacturing, and assembly methods.
- Experienced with rapid prototyping methods and limitations
- Fluency in English, with excellent written communication skills for technical documentation.
- Excellent knowledge of CAD Design and tools such as e.g. Solidworks, CATIA, Creo, or equivalent, 3D and 2D drawings, assembly, and stacking tolerances.
- Industrialization know-how IQ/OQ/PQ, verification and validation.
- Experience in (bio-based) polymer choices and characterizations is a plus.
- Experience in Product Risk management and Usability engineering, D-FMEA, P-FMEA.
- Excellent written and verbal communication skills with the ability to adjust to the audience.
- Willingness to work flexibly, in an interdisciplinary and international environment.
- Strong analytical skills and process-oriented work style with a structured, independent approach to work and focus on getting things done
- Willingness to contribute to women’s health changes and innovation.

**About the offer**
- 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.

**Job Types**: Full-time, Permanent

**Experience**:

- injection plastique: 3 years (required)
- dispositif medical: 3 years (required)

**Language**:

- Anglais (required)

Work Location: Hybrid remote in 25000 Besançon

Application Deadline: 28/02/2025