Job Description – Biosafety Engineer (Packaging & Sterilization)
Materialise is a dynamic international high-tech company, founded in 1990 and headquartered in Belgium, with over 1,500 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.
Are you interest in additive manufacturing activities in a medical environment? Are you passionate about patient safety? Would you love to work on the crossroads between engineering and biology? Then it’s you we are looking for to complete our team as a Biosafety Engineer (Packaging & Sterilization).
Biosafety Engineer (Packaging & Sterilization)
- Within the Medical Business Unit, you are part of the team that ensures the biocompatibility of our medical devices and that develops and validates their cleaning, packaging and sterilization processes.
- You are a specialist on sterilization (e.g., radiation, steam, ethylene oxide) and (sterile and non-sterile) packaging of medical devices. In this way, you support the Development, Process Engineering, Quality, and Manufacturing team for related activities.
- You investigate packaging and sterilization techniques and develop new methods to package or sterilize new or existing devices.
- You generate validation protocols for new devices and changed processes. You execute and coordinate the validation activities in accordance with applicable standards, cGMP and regulatory requirements.
- You effectively plan development and validation activities and address priorities between different projects so that schedules are met, productivity maximized, and costs reduced.
- You interact closely with all stakeholders, both internally (including the Development, Process Engineering and Manufacturing teams) and externally (including test labs, packaging suppliers and sterilization providers), to ensure good communication and swift collaboration.
- You develop and set-up monitoring programs in collaboration with the Process Engineering team and the sterilization providers.
- You promptly evaluate the impact of changed guidelines, standards or regulatory requirements and formulate adequate actions.
- You have a Bachelor or Master Degree in Engineering (Biomedical, Biochemistry, Mechanical,…).
- You have a couple of years of experience in the medical device industry. A background in biocompatibility, cleaning, packaging and sterilization validation of medical devices is a plus.
- You preferably have knowledge of good documentation practices, cGMP guidelines and international regulations pertaining to the production of medical devices.
- You are able to work on multiple projects simultaneously, set priorities and establish short and long-term planning horizons to complete these projects.
- You work effectively as a team member to accomplish deadlines and objectives, yet make independent decisions on various tasks.
- You are analytical and creative, and have a problem solving attitude.
- You are proficient in English and have good communication and technical writing skills.
- You are passionate about patient safety and the satisfaction of our end customer, the surgeon.
People are the cornerstone of Materialise and we treasure the talent, skills, and values of our employees very highly. We believe that maintaining the right environment and culture for employees is crucial for an organization’s success. Therefore, we are devoted to building a global team of specialists in an open environment that favors personal growth. Programs have been put in place to keep our fair, direct company culture alive.
Moreover, we proudly invest in personal development and offer challenging careers where employees are empowered to grow professionally as well as personally. You will liaise with different people throughout the organization on a daily basis and we guarantee that no day will be the same. Your effort and energy will be rewarded with a competitive salary and with extralegal advantages. In order to have a good work-life balance, we offer you flexible working hours.