Development Engineer — CMF Standard Solutions
PARIS, 75
il y a 12 jours
What you will do
Clinical and technical discussions with surgeons
- Gather surgeon input
- Identify market and user needs
- Translate user needs into technical requirements
Designing new medical devices and improving existing devices
- Create output documentation (design/system specifications, including technical drawings)
- Define and execute verification and validation activities
- Create and review technical documentation (DHF and Technical File)
- Maintain and organize Design History Files for medical devices according to quality management system procedures and requirements
- Design transfer to relevant teams across the company
- Contribute to and lead design control process improvements
Technical communication with subcontractors
- Design products according to the chosen manufacturing methods
- Handle technical discussions with subcontractors
Your profile
- Strong competencies in standard product design (including functional dimensioning, CAD, technical drawings, numerical simulation tools), product industrialization, standard production processes (such as milling, forging, laser cutting), ideally related to medical bone screws and instruments
- Initial experience in standard product design and development with a strong technical focus is required
- Proficient in spoken and written English, particularly in the context of drafting, reviewing, and presenting technical documentation and reports to diverse audiences, including technical and non-technical stakeholders
- Rigorous, organized, and structured
- Able to plan, execute, and work with minimal supervision and independent judgment while taking accountability for tasks
- Able to lead technical discussions and coordinate effectively with cross-functional teams to align project goals and timelines
- Can easily communicate with team members as well as with partners, surgeons, and subcontractors, and be able to adapt
- Critical thinking and decision-making capabilities, with a proven track record of independently analyzing complex technical challenges and implementing innovative, effective solutions
- Knowledge of design control processes and hands‑on experience managing project documentation within medical device design history files (DHF)
- Familiarity with agile methodology is not required, but would be an advantage
- A good understanding of Medical Device Regulation (e.g., MDR) and quality management systems (e.g., ISO 13485) is preferred
- Experience with risk management processes (e.g., FMEA, hazard analysis) and the ability to evaluate and mitigate risks in product designs and processes
Location and type of contract
- Paris, France
- Hybrid
- Full-time
- Associate level
- CV in English
Entreprise
Materialise
Plateforme de publication
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