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Development Engineer — CMF Standard Solutions

Materialise -
Paris (75)

Soumettre votre candidature

Détails de l'emploi

Temps plein

Avantages

Évènements d'équipe

Qualifications

Anglais
Gestion des risques
Agile

Description complète du poste

PARIS, FRANCE

SOFTWARE ENGINEERING & RESEARCH

HYBRID

FULL-TIME

ENGLISH CV

Our medical device portfolio comprises a broad range of solutions for cranio-maxillofacial surgery, which can be categorized into standard and personalized devices. The Device Development Engineer will play a key role in a cross-disciplinary agile team, driving the release and continuous improvement of standard CMF devices, ensuring compliance with the established quality management system while proactively contributing to the development of new processes and innovative solutions. R&D activities for personalized (3D-printed) medical devices are out of scope for this position.

Job description

The Device Development Engineer is expected to work with a high degree of autonomy, lead technical problem-solving efforts, and provide expert guidance to ensure alignment with the business line's objectives and key results. This role requires balancing technical expertise with strategic priorities to deliver impactful results.

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

What we offer

Healthy life-work balance

When creating a better and healthier world, a good place to start is with yourself. That's why we encourage our employees to prioritize their overall well-being, fostering physical fitness, mental resilience, and social connections through a range of workshops, sports activities, and other events and initiatives that contribute to a balanced and fulfilling work-life harmony.

Hybrid working & flexibility

Personal growth and career advancement

Team building

Innovation is key

Location and type of contract

Paris, France
Hybrid
Full-time
Associate level
CV in English

Working at Materialise

Materialise is a dynamic, international high-tech company, founded in 1990 and headquartered in Belgium, with over 2,300 employees worldwide. Materialise’s mission is to innovate for a better and healthier world through its software and hardware infrastructure and in-depth knowledge of additive manufacturing (also known as 3D printing). Our customers are in diverse industries, such as automotive, aerospace, medical, research, and academia.

As a growing company, Materialise is always looking for enthusiastic professionals who want to work in an environment full of revolutionary technology and surrounded by people passionate about their work.

Soumettre votre candidature

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