Device Development Engineer — CMF Personalized Devices

Materialise NV; Paris; Hybride; EUR 35 000 - 50 000; Plein temps

Résumé du poste

A leading company in the medical device industry is seeking an entry-level Device Development Engineer to join their dynamic team in Paris. This role involves driving the design and continuous improvement of personalized cranio-maxillofacial devices. As part of a cross-disciplinary Agile team, you will contribute to innovative solutions while ensuring compliance with quality management systems. Ideal candidates will have strong mechanical engineering skills and a passion for healthcare innovation.

Prestations

Hybrid working & flexibility

Personal growth and career advancement

Team building activities

Innovative work environment

Qualifications

• Proficient in drafting and reviewing technical documentation.
• Ability to work with minimal supervision and lead discussions.
• Good knowledge of medical device regulation (e.g., FDA, MDR).

Responsabilités

• Design new medical devices and improve existing devices.
• Gather input from surgeons and translate user needs into technical requirements.
• Execute verification and validation activities.

Connaissances

Advanced mechanical engineering

Design for additive manufacturing

CAD

Numerical simulation

Statistical analysis

Mechanical test methods

Critical thinking

Formation

Bachelor's or Master's in Mechanical Engineering or related field

Description du poste

PARIS, FRANCE

ENGINEERING

HYBRID

ENGLISH CV

The Materialise medical device portfolio comprises a wide range of solutions for cranio-maxillofacial (CMF) surgery, categorized into Standard and Personalized medical devices. The Device Development Engineer will play a key role in a cross-disciplinary Agile team, driving the release and continuous improvement of personalized CMF devices. In this position, the engineer will take ownership of the design history files (DHFs) for personalized CMF devices, ensuring compliance with the established quality management system while proactively contributing to the development of new processes and innovative solutions.

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 objectives and key results defined by the business line. This role requires balancing technical expertise with strategic priorities to deliver impactful results.

What you will do

Clinical and technical discussions with surgeons

• Gather input from surgeons
• Identify market and user needs
• Translate user needs into technical requirements

Design new medical devices and improve existing devices

• 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.
• Transfer the design to relevant teams across the company
• Contribute to and lead design control process improvements

Handle technical communication with operations teams

• Design products according to the chosen manufacturing methods
• Ability to evaluate designs for performance

Your profile

• Expertise in advanced mechanical engineering, design for additive manufacturing (DfAM), CAD, numerical simulation, statistical analysis, and mechanical test methods
• Ability to independently evaluate and optimize designs for performance and manufacturability
• Proficient in spoken and written English, particularly in drafting, reviewing, and presenting technical documentation and reports to diverse audiences, including technical and non-technical stakeholders
• Rigorous, organized, and structured
• Ability to plan, execute, and work with minimal supervision and independent judgment while taking accountability for tasks
• Ability to lead technical discussions, mentor junior team members or interns, and coordinate effectively with cross-functional teams to align project goals and timelines
• Critical thinking and decision-making capabilities, with a proven track record of independently analyzing complex technical challenges and implementing innovative, effective solutions
• Good knowledge of Design Control Processes and hands-on experience managing project documentation within Medical Device DHFs.
• Familiarity with agile methodology is not required but an advantage
• Good understanding of medical device regulation (e.g., FDA, MDR) and quality management systems (e.g., ISO 13485), with the ability to ensure compliance independently in development activities
• 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

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
• Entry level

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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.