Senior Device Development and Process Engineer — Standard Devices
Materialise's medical device portfolio comprises a broad range of solutions for cranio-maxillofacial surgery, categorized into Standard and Personalized medical devices. We are seeking a Device Development and Process Engineer who 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 on personalized (3D-printed) medical devices are out of scope for this position.
Job description
As the Senior Device Development and Process Engineer, you are 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
Development activities :
- Handle clinical and technical discussions with surgeons
- Gather input from surgeons
- Identify market and user needs
- Translate user needs into technical requirements
- Design of new medical devices and improvement of 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
- Handle technical communication with subcontractors
- Design products according to the chosen manufacturing methods
- Handle technical discussions with subcontractors
- Develop the right processes
- Standard manufacturing methods (turning, milling, laser cutting,…)
- Post-processing activities (anodization,…)
- Quality inspection methods
- 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
Your profile
- Advanced competences 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, plates and instruments
- Having a first 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
- 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
- Communicate easily with people within the team 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
- Good 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
- Good understanding of Medical Device Regulation (e.g., 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
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.
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.
Location and type of contract
- Paris, France; Leuven, Belgium
- Hybrid
- Full-time
- Associate level
- CV in English
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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.