Achieva Group Ltd

Lead Expert - Medical Device Technical Expert

7 days left

CHF90 - CHF97 per hour
03 Feb 2021
05 Mar 2021
Sophie Fosh
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Our global pharmaceutical client has a new vacancy as a Lead Medical Device Technical Expert focussing on Human Factors. 

Our client is open to candidates from the EU/ Switzerland. 

6 months full time initial contract

Job Title: Lead Expert User Experience

Job Purpose
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.

Major Activities
• 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 activiites in complaince with applicabple Medical Device/Combination Product SOPs and Regulations throughout the development process

Individual Activities
• Design, plan, perform, interpret and report results, 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

Minimum Requirements:
• Bachelor’s or Master degree in engineering, ergonomics, psychology, human factors, usability, user interface design, industrial design/graphic design or related discipline.
• Excellent skills in English, verbal and written are required.

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, including:

• 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

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