Biosafety Engineer

20 Jul 18 Belgium (HQ) Biomedical Engineering

The Company

Founded in 1990, Materialise is a high-tech international company with over 1,300 employees worldwide. Materialise’s mission is to contribute towards a better and healthier world through its innovations in 3D printing software and in-depth knowledge of Additive Manufacturing (also known as 3D Printing). Our customers are part of industries as diverse as automotive, aerospace, design, healthcare and academia.

As a growing company, Materialise is always looking for enthusiastic professionals who want to work in an environment full of revolutionary technology, surrounded by people passionate about their work.

Profile

  • 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 assist in assuring that our medical devices meet the appropriate cleanliness levels by defining the cleaning process that is most suitable for a particular device. Subsequently, you contribute to the validation of this cleaning process in accordance with applicable standards, cGMP, and regulatory requirements. Finally, you set-up monitoring and revalidation programs in collaboration with the Process Engineering and Manufacturing team.
  • You support biological safety assessments of the materials and manufacturing processes for new devices and any changes thereof for existing devices in accordance with ISO 10993 standards.
  • You 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.
  • You act as an ambassador and safeguard of biological safety within Materialise Medical.
  • You effectively plan development and validation activities and address priorities between different projects so that schedules are met, productivity maximized, and costs reduced.
  • You promptly evaluate the impact of changed guidelines, standards or regulatory requirements and formulate adequate actions.

Qualifications

  • You have a Master Degree in Engineering (Biochemistry, Bio(medical) sciences,…), Biology or Microbiology.
  • You have a 1 or 2 years of experience in the medical device or pharmaceutical industry. A background in biocompatibility, cleaning, packaging or sterilization validation of medical devices is a plus.
  • You are familiar with ISO 10993 and 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 proactive, take on responsibility, 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.

 

Materialise offers

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.