Biosafety Engineer
Are you interested in additive manufacturing activities in a medical environment? Are you passionate about patient safety? Would you love to work at the crossroads between engineering and biology? Then, we are looking for you to complete our team as a Biosafety Engineer.
What you will do
- Within our medical business unit, you'll join a team of specialists who ensure the biocompatibility of our medical devices to develop and validate their cleaning, packaging, and sterilization processes
- Participate in medical device development by supporting biological safety evaluations in accordance with ISO 10993-1 and executing cleaning and sterilization process validations
- Develop new or optimized packaging for sterile and non-sterile medical devices and test their performance
- Set up and take part in monitoring programs to ensure the continued fulfillment of requirements
- Contribute to regulatory submissions of new devices
- Build a thorough understanding of the manufacturing process, especially the steps related to cleaning, packaging, and sterilization, to effectively plan new development and validation activities
- Create and finalize validation protocols and reports, ensuring they are clear, concise, and compliant with work instructions and standards
- Assess the impact of the process or product changes and propose adequate actions
- Plan and follow up on test sample production with the manufacturing team and suppliers
- Coordinate tests performed at external test labs
- Interact closely with internal stakeholders (including the quality, development, process engineering, and manufacturing teams) and external partners (including test labs and suppliers) to ensure good communication and swift collaboration
- Act as an ambassador and safeguard biological safety within Materialise Medical
Your profile
- At least 4 years of experience as a biosafety engineer
- Master's degree (engineering, biochemistry, biology, or medical)
- Knowledge and understanding of regulatory requirements, standards, and guidance documents in the field of biocompatibility evaluation, cleaning validation, packaging development, or sterilization validation of medical devices
- Able to work on multiple projects simultaneously, set priorities, and establish short and long-term planning horizons
- Effective as a team member in accomplishing project deadlines and objectives, yet able to work and make decisions independently to reach goals
- Clear and effective verbal communication and technical writing skills in English
- Good analytical skills, meticulous approach with a high level of attention to detail
- Passionate about patient safety and customer satisfaction
- Previous experience in the medical device industry is a plus
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
- Full-time
- Hybrid
- Associate-level position
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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.