R&D Scientist – Formulation Development About us Quirem Medical is a fast growing medical device company with a mission to improve quality of life and survival of patients living with cancer, by offering the best-in-class solutions in Therapeutic Interventional Oncology (TIO). Our core products consist of radioactive holmium microspheres that have the unique ability to be accurately and quantitatively imaged. In this phase of accelerated growth and development, we are searching for a R&D Scientist to contribute to the further expansion of our TIO product portfolio by developing new medical devices based on micro- and nanoparticle technology. The offices and lab facilities of Quirem Medical are based in Deventer. As of July 2020, Quirem Medical is a wholly owned subsidiary of Terumo Europe.
About the R&D Department Team The purpose of the Quirem Medical R&D team is to drive innovation by translating fundamental technical knowledge into commercially viable therapeutic medical devices in the TIO area. We have the ambition to become a leader in the field of TIO (drug delivery, embolization, internal radiation, ablation) and the R&D department is responsible for the development of new medical devices that can bring innovative and effective treatments to cancer patients.
Your Function This position reports to the Formulation-Chemistry R&D Manager TIO. The R&D Scientist plays an important role in the design and development of medical device products. This position is responsible for providing technical expertise, planning, and executing several projects related to the development of new and current medical devices. This position will ensure that marketed and new medical devices are properly designed to facilitate manufacturability, approval by notified bodies and commercialization. This role is for preferably 40 hours per week. Our office is based in Deventer.
Your Function Requirements
* Bachelors, Master Science or PhD in a scientific discipline (e.g. pharmacy, chemistry, chemical engineering)
* 3+ years previous experience in the medical device industry
* Experience in the field of particle development (microparticles, nanoparticles) is preferred
* A highly analytical approach to problem solving, intense curiosity, and strong desire to innovate in the medical device field
* Demonstrated experience with execution of product design, development and documentation (DHF)
Teamwork skills in a multi-disciplinary environment
Ability to multi-task in different projects, detail-oriented and good organizational skills
Capable of working independently with moderate supervision
Excellent communication and presentation/documentation skills and good knowledge of English (writing and verbal)
Knowledge and experience in working in a quality & regulatory driven environment (understanding of cGMP & ISO standards and requirements in FDA and EU regulated countries)
Preferably licenced in working with radioactive open sources (in possession of 5B degree, or TS VRS-D)
Experience in risk management of medical devices is preferred
What You Will Do
* Designing and executing feasibility studies
* Development and validation of Quality Control methods
* Designing pre-clinical trials for new products or marketed products
Contribute to the DHF and regulatory submissions of new medical devices and marketed products
Ensure that product documentation is in accordance with Quality System requirements, design control, quality, company regulations and national and international regulatory body requirements
Ensure that new products or product enhancements are designed to facilitate manufacturability
Writing or verifying specifications, test processes, equipment and specifying raw materials to ensure the concepts and/or prototypes meet their requirements
What We Offer We offer you a challenging environment in which you can truly make a difference. We believe in the concept of a High Performance Team with an open working culture with short communication lines, which allows for quick decision making. Our competitive remuneration and benefits will be based on experience.
Contact Us To apply for this role, send your CV and motivation letter