For our client, a leading international pharmaceutical company with headquarters in Basel, we are looking or a motivated personality in the function of
Lead Expert User Experience (m/f), 100%, Basel
Provide end-to-end HFE or UX activities and expertise in a broader cross-functional development team. Apply innovative and user-centric design thinking in compliance with both company quality assurance standards and applicable regulations to drive patient experience and innovation across the connected health portfolio.
- Support all and leads select activities related to the development of the assigned connected health projects.
- Coordinate with team members assigned multiple or complex device development activities.
- Ensure appropriate planning of workload and resources internally and externally, controlling costs and timescale of the respective project tasks.
- Document activities in compliance with applicable Medical Device/Combination Product SOPs and Regulations throughout the development process
- Report and present scientific/technical results internally and contribute to publications, presentations and patents.
- Support DRA to prepare select Medical Device/Combination Product pre-registration documents and provides input to answer health authority questions.
- SubWay author, reviewer and approver (Quality and Medical Device)
- Design, plan, perform, interpret and report results of HFE or UX activities, processes and procedures.
- Address interaction for Health Authorities (dossier, briefing books) related to HFE topics in alignment with cross-functional teams (GPTs, Regulatory)
- Lead and manage all role related projects/local network activities, support/coach team members, participate in sub-teams and contribute to overall strategies and goals
- Drive as HFE or UX expert the developments and understanding for behavior science and user-centric Connected Health products and solutions
- Work closely with Connected Health colleagues to develop design concepts (e.g. prepare wireframes and user flows and generate first UX mockups) and help develop persona in conjunction with Product Owners
- Lead the collaboration with external HFE and UX partners and contribute to the selection process
- Generate, review and approve documents such as Design Control, Risk Management, HFE or UX and qualification documents (incl. labelling master file e.g. user interface specification, INST file)
- Promote and utilize the innovation toolbox to approach innovation strategically with engagement of people across Connected Health organization
- Bachelor's or Master degree in engineering, ergonomics, psychology, human factors, usability, user interface design, industrial design/graphic design or related discipline.
- An ideal candidate would have a relevant degree and 5 to 10 years of experience in applying Human Factors Engineering/usability to medical devices development, preferably in the pharmaceutical industry
- Good understanding and specific knowledge on applying Human Factors Engineering processes to medical device development from concept generation to health authority submission
- Experience in project / program management
- Experience in developing apps, software and/or industrial design
- Experience in managing user studies (performed by vendors or self-managed)
- Experience in developing and documenting Human Factors activities for medical devices as required by regulation
- Good understanding of the risk management activities
- Excellent skills in English, verbal and written are required.
Place of Work: Basel
Starting Date: February 2021
End date: July 2021
Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Insa Voss (+41 61 270 80 07).