Process Validation Engineer
Materialise Medical pioneers many leading medical applications of 3D Printing enabling researchers, engineers and clinicians to revolutionize personalized treatments that help improve and save lives. In the Cranio-Maxillofacial (CMF) field Materialise develops & offers a comprehensive and continuously expanding range of patient-specific surgical guides & implants to a growing & diversifying global customer base.
To further drive & support our Medical Production activities Materialise Medical is looking for a Process Validation Engineer to join the HQ Process Engineering team (Leuven).
What you will do
- You will be stepping into a cross-functional agile team which focuses on CMF product development as well as manufacturing process development and implementation.
- With your strong engineering mindset, you develop thorough expertise in additive manufacturing, post-processing, cleaning and quality inspection technologies, allowing you to become the technical expert and GoTo for both development & operational questions. Next to that, you also gain a solid understanding of CMF product specifics, enabling you to effectively connect product requirements to the corresponding process needs.
- You are involved early in the development of new or updated devices, assessing manufacturability and process validation needs. In close collaboration with the device development team, you assist in the definition of a clear and comprehensive set of product specifications which will serve as input for the process validation and implementation after design transfer.
- You own the validation programs for the manufacturing processes and corresponding equipment. You create these validation programs from scratch for new products and processes or update them for each product and process change, after which you execute (or coordinate the execution of) the corresponding equipment validations (IQOQPQ).
- Where required for process or product changes, you set up, execute and analyze process characterization studies to understand the impact of process parameters on process and product output.
- Data collected in both validation and operational setting allows you to define new or updated manufacturing processes, aiming to improve operational quality and efficiency. You drive process development and operational roll-out of various process changes and translate this into operational success by providing the right process documentation, including work instructions, operator training and support.
- You guarantee compliance with Quality Management System requirements by documenting all phases of the process characterization, validation and operational implementation validation per internal quality procedures.
- As a member of the process engineering team, you will enjoy close cooperation with stakeholders from operational, device development, biosafety, research, quality and regulatory teams. Through involvement in a variety of activities and projects, we set up a growth trajectory in which you can shape your own future within Materialise.
Your profile
- You have a master’s degree in engineering
- You have previous experience working in a process (validation) engineering role within regulated industries such as medical devices, pharmaceuticals or aerospace. Experience with design transfer activities is considered a strong plus
- You are quality oriented and have an eye for detail, but you also don’t get stuck on this. You are able to think out of the box when needed
- You are good at troubleshooting and problem solving
- You have a strong and versatile work ethic and you’re eager to learn
- You are proactive and self-organized. You take initiative and demonstrate full ownership of your tasks
- You value and uphold impeccable coordination
- Strong English verbal & written skills required
- Note: A motivation letter is requested when applying for this position.
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
- Leuven, Belgium
- Engineering
- Full-time
- Hybrid
- 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.