R&D & Process Engineer - Standard Devices

Materialise

Paris, France

The Materialise medical device portfolio comprises a broad range of solutions intended for craniomaxillofacial surgery, which all can be categorized into Standard and Personalized medical devices. The Research, Development, and Process Engineer will conduct research and development activities for our Standard products and implement process changes (including design transfer activities) to contribute towards consolidating and expanding our Standard device portfolio. R&D and process activities on personalized (3D-printed) medical devices are out-of-scope for this position.

What you will do

Research and innovation activities:

Handle clinical and technical discussions with surgeons;
Gather surgeons' input and identify market and user needs;
Translate user needs into technical requirements;
Scientific and technological watch;
Assess the technical feasibility of new products.

Development activities:

Design new medical devices and improve existing devices;
Create output documentation;
Define and execute verification and validation activities;
Create, review, and maintain technical documentation (DHF and Technical File);
Design transfer to relevant teams across the company;
Handle technical communication with subcontractors.

Process engineering activities:

Build hands-on expertise on the product and process level:
- Standard manufacturing methods;
- Post-processing activities;
- Quality inspection technologies.
Identify, define, and implement required process changes, including new process validations (for both internal and outsourced processes) and process flow optimizations to increase efficiency;
Set up processes from scratch for new product introductions;
Translate those changes into operational success by providing the right process documentation (work instructions), training, and support.

Your profile

Must-have: Strong competencies in product design (including functional dimensioning, CAD, technical drawings, and numerical simulation tools), product industrialization, and standard production processes (such as milling, forging, and laser cutting), ideally related to medical bone screws and instruments;
Must-have: initial experience in the development of a standard product design portfolio with a strong technical focus;
Proficiency in spoken and written English is required, particularly when it comes to technical documentation;
Can communicate easily with team members, partners, surgeons, and subcontractors, and must be able to adapt;
Plan, execute, and work with minimal supervision and independent judgment;
Out-of-the-box thinking mentality is very important;
Experience managing project documentation according to the design control process within medical device DHF is preferred;
Knowledge of medical device regulation and quality management systems (ISO 13485) is preferred.

Apply Now

Don't forget to mention EuroEngineerJobs when applying.

Share this Job