What youll do at Elekta

The main focus of the role will be on biocompatibility. You will support the reprocessing and sterilization activities including steam sterilization & EO sterilization during the development of medical devices for Brachytherapy treatments. You will create and maintain all necessary documents which are essential to comply with all applicable standards and regulations worldwide.

You will report to the Hardware Director within the Engineering department of Brachytherapy and act as a subject matter expert (SME) in biocompatibility with a deep understanding of reprocessing and sterilization techniques.For reprocessing and sterilization you will work together with other subject matter experts. During all activities youll collaborate closely with colleagues in product management QA/RA clinical specialists external laboratories and external consultants.

Responsibilities

In this role you will ensure our devices meet the highest safety and regulatory standards throughout their lifecycle.

• Create and maintain up-to-date technical documentation including Biological Safety Evaluations and Design & Development Files (DDFs).
• Train product and process development engineers in biocompatibility sterilization and reprocessing best practices.
• Perform peer reviews on biocompatibility reprocessing and sterilization engineering documents.
• Lead product testing and analysis to external laboratories; review protocols monitor progress and review the test reports.
• Provide input and review product documentation such as Instructions for Use information bulletins and labels in your expertise area.
• Define work breakdown structures related to biocompatibility reprocessing and sterilization during product development including effort and lead time estimations.
• Support investigations root cause analyses and propose improvements related to your expertise areas.
• Act as a SME in audits regulatory submissions and technical discussions with internal and external stakeholders.
• Contribute to strategies procedures and work processes to improve the way of working.
• Participate in early-stage innovation technical reviews and agile development ceremonies (SAFe framework).

What youll bring

• University degree in chemistry chemical engineering pharmaceutical biomechanical engineering or comparable. A chemical background with affinity to hardware is a must.
• At least 3 years of relevant work experience with biocompatibility and preferably reprocessing analysis.
• Experience in writing Biological Safety Evaluations including Toxicological Risk.
• Assessments and chemical characterizations and reprocessing reports.
• Experience with the coordination of outsourced testing (e.g. biocompatibility testing FTIR gas chromatography).
• Knowledge of regulations and standards in the field of biocompatibility cleaning disinfection sterilization bioburden BET (LAL) Packaging and sterile barrier systems.
• Knowledge of Regulatory Affairs requirements related to CE and FDA is considered a plus.
• Understanding of human anatomy physiology and pathology in the context of medical device use is a plus.
• Knowledge of radiotherapy devices is considered a plus.
• Professional working proficiency in English; proficiency in Dutch or willingness to learn is a plus.

To succeed in this role we believe you can describe yourself as an accurate analytical person with problem-solving abilities. The role is a part of the multidisciplinary team therefore the ability to work independently and as a part of the team is crucial.

We encourage you to apply even if you dont meet every requirement as long as you are enthusiastic about the opportunity and have some relevant experience. Your unique skills and experiences could be exactly what were looking for!

Why should you join Elekta

In this role you will work for a higher purpose: hope for everyone dealing with cancer and for everyone regardless of where they are in the world to have access to the best cancer care. Additionally our benefit package includes:

• 40 paid vacation days per year (27 vacation 13 ADV)
• Global bonus plan or Profit scheme
• Travel allowance
• Pension fund Metalektro 50/50 payment
• Insurance discounts
• Active staff association
• Tax benefits for fitness centers and bicycle purchases
• Hybrid work option (you are required to work on location at least 3 days/week).

Hiring process

We look forward to hearing from you! Please submit your application in English via the Apply button. Applications will be reviewed on an ongoing basis until the suitable candidate is identified.