- Participate in drawing up and validating specifications
- Carry out the design and layout of new products in accordance with the requirements of the specifications, target costs and performance and quality standards.
- Follow the project planning established by the Program Director/Project Manager.
- Monitor internal and external production (subcontracting) / Contribute to industrialisation (design reviews and drawings)
- Prototypes associated with projects
- Devices for testing and launching
- Participate in V&V (Verification/Validation), supported by the Project Manager.
- Interact with the organisation (MKT, OPS, RA/QA) at various stages of the projects, from input data collection to product launch.
- Ensure Design Transfer.
- Write all or part of the Design File (Project Manager as back-up, depending on the difficulty of the subject), including in particular activities such as:
- Specifications
- Risk analysis
- Test protocols and reports
- Design review reports
- Functional and dimensional inspection instruction sheets
- Engineering degree (ENSAM, INSA, UTC or equivalent), if possible with a previous degree such as BTS CPI or DUT GMP.
- At least 5 years' experience in product development.
- Although this is a plus, it does not have to be solely in the field of medical devices. You could also work in an industry developing technical products in a highly regulated environment.
- Proficiency in SolidWorks CAD software.
- Knowledge of the PDM system would be a plus.
- Languages:
- French mandatory
- Fluency in written and spoken English (interaction with subcontractors, surgeons and teams around the world, as well as drafting the DHF in English).
- Soft skills requested for the position:
- Flexible
- Adaptable
- Able to manage several tasks simultaneously and work independently
- Able to meet deadlines and prioritise work
- Solution-oriented
- Team player
- Modern infrastructure
- Sports activities during lunch break
- Team events
- Direct cooperation with all departments
- Young, motivated team
- Agile and international environment
- Full time position
- Home office: 1 day per week
- Good Social insurances package
- Location: HQ Geneva
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Beschreibung
Posted 4 Monaten agoR&D Engineer
Are you a highly skilled Engineer who is dreaming of a job with a real impact on patients'lives?
Do you want to work for an innovative specialist spinal implant company and play a crucial role in ensuring efficiency of our manufacturing processes?
If yes, come to join our R&D team
Together we can shape the future of the healthcare.
As a R&D Engineer, you will participate to the development of new products (implants and instruments) for the spine surgery as well continuous improvements of texisting lines of products.
You will contribute to the writing and updating of the Design History File (DHF) in accordance with the quality norms ISO13485, 21CFR Part 820, MDD 93/42/EEC and MDR 2017/745.
Your main responsibilities will be:
A. Developing new products and improving existing product lines
B. Drawing up/updating the DHF
Your profile:
Who we are
SPINEART is a company for engaged passionate and talented people who are driven to seek the innovation, growth and opportunity we offer.
Not only will you be part of a passionate and inspiring team but you will also have the opportunity to actively shape the future of the company.
At SPINEART you will find a dynamic atmosphere ensuring short decision-making processes and freedom for satisfying work.
Our success also depends on our team's value. The human being is at the centre of our concerns. We pay special attention to our recruitment to make Spineart a great place to work.
For us, soft skills are as important as hard skills. What we expect from our employees is nothing short of real team spirit, mutual assistance, and self-transcendence.
Our philosophy: Quality, Innovation, Simplicity
Our values: Respect, Integrity, Solution oriented
What we offer