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Medical Device Technical Expert - Human Factor
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Engineering, Design, Usability, Engineer
Projektbeschreibung
For our client in BASEL we are looking for a MEDICAL DEVICE TECHNICAL EXPERT - HUMAN FACTOR for a 6-MONTHS contract.
JOB TITLE: MEDICAL DEVICE TECHNICAL EXPERT - HUMAN FACTOR
DURATION: 01/01/2019 TO 30/06/2019 (EXTENSION POSSIBLE)
LOCATION: BASEL
WORKLOAD: 100%
DESCRIPTION:
The Human Factors Engineer will be responsible for independently leading the planning, execution and reporting of human factors studies and user interface design, according to current regulations and guidelines within the medical device and pharmaceutical industries.
. Provides human factors support throughout the product development life cycle including user needs identification, development of user profiles and use scenarios, task analysis, use-related risk analysis, generation of hardware and software design concepts (creation of physical models and prototypes, graphical user interfaces, and product graphics), user interface design and instructions for use.
. Plans and executes formative and summative user studies, reporting and presenting design recommendations to the project team.
. Defines appropriate sample sizes and statistical methods for analysis.
. Performs anthropometric, biomechanical, ergonomic, and systems safety analyses to identify and assess risk in product development.
. Cross-examines and optimizes developmental prototypes and provides ergonomic, usability and safety assessments for consumer healthcare products, medical devices and pharmaceutical packaging.
. Leads IFU design and development including validation.
. Closely collaborate with cross functional stakeholders (eg risk management, Drug Regulatory Affairs, clinical development ).
. Supporting Human Factors related documentation for Health Authority registration in collaboration with Drug Regulatory Affairs.
. Works independently against self-set targets when necessary.
. Management of external vendors.
MUST HAVES:
- Bachelor's or Master degree in engineering, ergonomics, human factors, usability or related discipline.
- Excellent skills in English, verbal and written are required. Other language skills, eg French, German are advantageous.
- At least 3 years of experience in applying Human Factors Engineering to medical devices development, preferably in the pharmaceutical industry, including.
- Good understanding of medical devices development processes in general.
- 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 and documenting Human Factors activities for medical devices as required by regulation.
- Proven track record of successfully managing interfaces to other functions.
- Experience in managing external suppliers for user studies (formative and summative studies)
- Good understanding of the risk management activities
- Good communication and problem solving in the team and across organizational boundaries.
For further details please contact:
Anna Undas
(see below)
JOB TITLE: MEDICAL DEVICE TECHNICAL EXPERT - HUMAN FACTOR
DURATION: 01/01/2019 TO 30/06/2019 (EXTENSION POSSIBLE)
LOCATION: BASEL
WORKLOAD: 100%
DESCRIPTION:
The Human Factors Engineer will be responsible for independently leading the planning, execution and reporting of human factors studies and user interface design, according to current regulations and guidelines within the medical device and pharmaceutical industries.
. Provides human factors support throughout the product development life cycle including user needs identification, development of user profiles and use scenarios, task analysis, use-related risk analysis, generation of hardware and software design concepts (creation of physical models and prototypes, graphical user interfaces, and product graphics), user interface design and instructions for use.
. Plans and executes formative and summative user studies, reporting and presenting design recommendations to the project team.
. Defines appropriate sample sizes and statistical methods for analysis.
. Performs anthropometric, biomechanical, ergonomic, and systems safety analyses to identify and assess risk in product development.
. Cross-examines and optimizes developmental prototypes and provides ergonomic, usability and safety assessments for consumer healthcare products, medical devices and pharmaceutical packaging.
. Leads IFU design and development including validation.
. Closely collaborate with cross functional stakeholders (eg risk management, Drug Regulatory Affairs, clinical development ).
. Supporting Human Factors related documentation for Health Authority registration in collaboration with Drug Regulatory Affairs.
. Works independently against self-set targets when necessary.
. Management of external vendors.
MUST HAVES:
- Bachelor's or Master degree in engineering, ergonomics, human factors, usability or related discipline.
- Excellent skills in English, verbal and written are required. Other language skills, eg French, German are advantageous.
- At least 3 years of experience in applying Human Factors Engineering to medical devices development, preferably in the pharmaceutical industry, including.
- Good understanding of medical devices development processes in general.
- 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 and documenting Human Factors activities for medical devices as required by regulation.
- Proven track record of successfully managing interfaces to other functions.
- Experience in managing external suppliers for user studies (formative and summative studies)
- Good understanding of the risk management activities
- Good communication and problem solving in the team and across organizational boundaries.
For further details please contact:
Anna Undas
(see below)
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik