Principal Scientist, Human Factors Engineering
Ascendis Pharma, Denmark

HFE specialist (Medical Devices)

Join the Device team in a leading and fast-growing biopharmaceutical company

Ascendis Pharma is currently expanding its activities within Medical Device and Combination Product development

You will become responsible for Human Factors Engineering (HFE) and usability related activities across medical device and combination product development projects. Additionally, you will drive development of Instructions for Use (IFU) and packaging materials. You will join a dynamic and experienced team, and you will report directly to the Director of Device Development.

Main areas of responsibility:

• Human Factors Engineering/Usability Engineering of medical devices and combination products (including preparation, review and maintenance of HFE/UE files and HFE/UE studies)
• Development, testing and design control of packaging, instruction and labelling materials for medical devices and combination products (including preparation, review and maintenance of design control documentation)
• Coordination of development activities with CMOs and consultants

You hold a relevant academic degree within engineering, pharmaceutical sciences or similar. You have several years of documented experience within medical device and/or combination product development from the pharmaceutical and/or medical device industry. Furthermore, you hold the following qualifications:

• Solid experience with medical device HFE/UE (according to e.g. ISO62366 and FDA guidelines)
• Solid experience with packaging, instruction and labelling material development and testing
• Solid experience with medical device design control (according to relevant regulations and guidelines)
• Experience with development of software as a medical device (SaMD)
• Project coordination experience during early and late-stage development
• CMO collaboration experience
• Good communication and collaboration skills

You are a highly motivated individual who enjoys being challenged and working in collaborative environments.

Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy and work with highly skilled and experienced colleagues to advance our exciting product pipeline.

Travelling: 10-20 days per year.

Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view to the harbour, the canals, and the sea.

For more details about the job or the company, please contact Thomas Ørts Pedersen, Director of Device Development on + 45 24441154 or . All applications must be submitted in English and are treated confidentially.

Application will be evaluated when received, so please apply as soon as possible.

Job Rewards and Benefits