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Medical Device Expert - Human Factor
Eingestellt von RM IT Professional Resources AG
Gesuchte Skills: Engineering, Usability, Design
Projektbeschreibung
Medical device expert - Human factor wanted for our Basel based client in the pharmaceutical sector.
YOUR EXPERIENCE/SKILLS:
- University degree in ergonomics, engineering, human factors, usability or related field
- 3+ years' background in applying Human Factors Engineering to medical devices development with Specific knowledge from concept generation to health authority submission
- Competency of project or program management coupled with developing and documenting Human Factors activities for medical devices as required by regulation
- Proven track record of successfully managing interfaces to other functions along with good understanding of risk management activities
- Confidence in managing external suppliers for user studies as well as strength in negotiating, presenting, communicating and convincing
- Languages: fluent English both written and spoken, German or French are a plus
YOUR TASKS:
- Providing human factors support throughout the product development life cycle, inclusive user needs identification, development of user profiles and use scenarios, use-related risk analysis and instructions for use
- Planning and executing formative and summative user studies along with reporting and presenting design recommendations to the project team
- Defining sample sizes and statistical methods for analysis as well as performing anthropometric, ergonomic, biomechanical and systems safety analyses to identify and assess risk in product development
- Analysing developmental prototypes and providing ergonomic, usability and safety assessments for consumer healthcare products, medical devices and pharmaceutical packaging
- Leading IFU design and development including validation and collaborating with cross functional stakeholders, such as risk management, Drug Regulatory Affairs and clinical development
- Supporting Human Factors related documentation for Health Authority registration in collaboration with Drug Regulatory Affairs
START: ASAP
DURATION: 06MM+
LOCATION: Basel, Switzerland
REF.NR.: BH13130
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.
GOING THE EXTRA MILE
NEW TO SWITZERLAND? In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more
YOUR EXPERIENCE/SKILLS:
- University degree in ergonomics, engineering, human factors, usability or related field
- 3+ years' background in applying Human Factors Engineering to medical devices development with Specific knowledge from concept generation to health authority submission
- Competency of project or program management coupled with developing and documenting Human Factors activities for medical devices as required by regulation
- Proven track record of successfully managing interfaces to other functions along with good understanding of risk management activities
- Confidence in managing external suppliers for user studies as well as strength in negotiating, presenting, communicating and convincing
- Languages: fluent English both written and spoken, German or French are a plus
YOUR TASKS:
- Providing human factors support throughout the product development life cycle, inclusive user needs identification, development of user profiles and use scenarios, use-related risk analysis and instructions for use
- Planning and executing formative and summative user studies along with reporting and presenting design recommendations to the project team
- Defining sample sizes and statistical methods for analysis as well as performing anthropometric, ergonomic, biomechanical and systems safety analyses to identify and assess risk in product development
- Analysing developmental prototypes and providing ergonomic, usability and safety assessments for consumer healthcare products, medical devices and pharmaceutical packaging
- Leading IFU design and development including validation and collaborating with cross functional stakeholders, such as risk management, Drug Regulatory Affairs and clinical development
- Supporting Human Factors related documentation for Health Authority registration in collaboration with Drug Regulatory Affairs
START: ASAP
DURATION: 06MM+
LOCATION: Basel, Switzerland
REF.NR.: BH13130
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.
GOING THE EXTRA MILE
NEW TO SWITZERLAND? In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik