Hardware Electronic Design - Embedded Software and Machine learning specialist for medical devices (M/W).

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

 

HW and SW design
Machine learning
Autonomy
Leadership

Your Responsibilities & Missions

About the role

Aspivix is seeking a talented and versatile HW electronics and SW - Machine Learning Specialist to drive innovation while assuming a strategic role akin to the Head of R&D locally. This role is pivotal in advancing Aspivix's digital and AI-enabled solutions for transcervical procedures while enhancing the company's overall technical capabilities. Key responsibilities include:


Electronics

  • Full cycle development in accordance to ISO 60601 and ISO 13485: manage all phases of electronic development from feasibility study through design development testing, reliability testing and optimizing PCB.
  • Digital signal processing, wireless communication and control.
  • System integration and optimization with mechanical design.
  • Debugging, Verification and Validation


Embedded Software Development & Machine learning/AI Integration

  • Design, develop, and optimize embedded software for microcontroller-based systems, ensuring performance, reliability, and compliance with medical device standards (IEC 62304).
  • Collect requirements, develop, test, and implement AI-powered features for Aspivix family devices, enhancing adaptability and performance for diverse gynecological procedures.
  • Develop firmware and real-time control algorithms tailored to Aspivix's products.
  • Design intuitive software interfaces for device control and data management.
  • Collaborate with hardware engineers to optimize the interaction between software and physical components.
  • Implement predictive models to optimize procedural workflows and patient outcomes.
  • Develop and update technical documentation from User requirement to Verification and Validation.
  • Document detailed designs in compliance with ASPIVIX’s QMS and regulatory requirements (MDR, ISO 13485, V-model, US FDA) and be responsible for software risk management
  • As well as development and maintenance of the technical files according to SOPs and international standard ISO/FDA (DHF-DMR-DHR)
  • Identify intellectual Property (IP) opportunities and strengthen company IP


Head of R&D function

  • Strategically plan and manage R&D projects to align with Aspivix’s vision and product roadmap.
  • Collaborate cross-functionally to integrate AI, new materials, and innovative designs into Aspivix's offerings.
  • Supervise the development of advanced suction heads and other technical enhancements.
  • Foster partnerships with research organizations or academic institutions to drive groundbreaking innovations



Supplier Management

  • Select and Manage external suppliers (contract manufacturing organization - CMO).



Documentation & Reporting

  • Actively collaborate with the development team, RA&QA team, external suppliers, and manufacturing.


About You

Responsibilities

  • Electronics
  • Embedded Software Development & Machine learning/AI Integration
  • Head of R&D function
  • Supplier Management
  • Documentation & Reporting

Must Have

  • Bachelors, Master’s or PhD in Electronics, Computer Science, Software Engineering, System engineering  or a related field.
  • Proven Experience in electronics development simulation, testing  and PCB design for medical devices.
  • Proven experience in software development in C/C++, Zephir or similar, machine learning, and AI implementation, preferably in medical technology or healthcare.
  • Experience to work in a highly regulated environment i.e. ISO 13485, ISO 60601.
  • Hands-on experience with Python, TensorFlow, or similar tools for machine learning applications.
  • Industrialization know-how IQ/OQ/PQ, Verification and Validation for electronic parts.
  • Strong project management skills, with the ability to lead multidisciplinary team members.
  • Exceptional communication skills, both technical and non-technical.
  • Strong analytical skills and process-oriented work style with a structured, independent approach to work and focus on getting things done.
  • Excellent written and verbal communication skills with the ability to adjust to the audience, English + other language advantage

Nice to have

  • Broad technical knowledge and willingness to learn new things in the field.
  • Willingness to work flexibly, in an interdisciplinary and international environment.
  • Additional languages is a plus.
  • 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 SA, is an equal opportunity employer committed to diversity. Each recruitment decision we make is based solely on the candidates’ knowledge, experience and skills.

ASPIVIX Story

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