Development Engineer — CMF Standard Solutions

About the Position

Development Engineer - CMF Standard Solutions

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.

Responsibilities

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

Requirements

• 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

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

At Materialise, we value the power of in-person connections and the advantages of remote work, allowing our employees the flexibility to enjoy the best of both worlds. You can work remotely up to 60% of the time and work flexible hours, depending on your particular role.

Personal Growth and Career Advancement

At Materialise, we’re committed to nurturing the professional development of our employees. We invest in our passionate people and empower them to explore and grow by offering diverse career paths that capitalize on their talents. Plus, we offer courses, external coaching programs, and in-house mentoring so that our employees can fulfill their potential.

Team Building

We cultivate a positive work culture so our employees have an enjoyable professional environment. Collaboration is key, so we organize activities that unite our employees, such as after-work events and team lunches. We want all our staff to feel connected in an environment that promotes strong bonds based on trust, respect, empathy, and friendship.

Innovation is Key

Innovation is not just a buzzword at Materialise; it's at the core of what we do. As pioneers in our industry, we create cutting-edge solutions, fostering an environment that supports and rewards ingenuity and leadership. We’re dedicated to shaping the future of 3D printing, recognizing and celebrating the creative spirit within all our global innovators.

About the Company

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.