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Medical Device Technical Expert - Human Factor (Ref. Nr.: EW2550)

Eingestellt von BRINE SA

Gesuchte Skills: Engineering, Design, Usability, Engineer

Projektbeschreibung

MEDICAL DEVICE TECHNICAL EXPERT - HUMAN FACTOR

We are offering a position as MEDICAL DEVICE TECHNICAL EXPERT to a candidate with following experience:

ROLE 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.

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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.
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Plans and executes formative and summative user studies, reporting and presenting design recommendations to the project team.
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Defines appropriate sample sizes and statistical methods for analysis.
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Performs anthropometric, biomechanical, ergonomic, and systems safety analyses to identify and assess risk in product development.
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Cross-examines and optimizes developmental prototypes and provides ergonomic, usability and safety assessments for consumer healthcare products, medical devices and pharmaceutical packaging.
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Leads IFU design and development including validation.
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Closely collaborate with cross functional stakeholders (eg risk management, Drug Regulatory Affairs, clinical development).
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Supporting Human Factors related documentation for Health Authority registration in collaboration with Drug Regulatory Affairs.
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Works independently against self-set targets when necessary.
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Management of external vendors.

MINIMUM REQUIREMENTS:

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Bachelor's or Master degree in engineering, ergonomics, human factors, usability or related discipline.
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Excellent skills in English, verbal and written are required. Other language skills, eg French, German are advantageous.
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At least 3 years of experience in applying Human Factors Engineering to medical devices development, preferably in the pharmaceutical industry, including.
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Good understanding of medical devices development processes in general.
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Specific knowledge on applying Human Factors Engineering processes to medical device development from concept generation to health authority submission.
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Experience in project/program management.
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Experience in developing and documenting Human Factors activities for medical devices as required by regulation.
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Proven track record of successfully managing interfaces to other functions.
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Experience in managing external suppliers for user studies (formative and summative studies)
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Good understanding of the risk management activities
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Good communication and problem solving in the team and across organizational boundaries.

ADDITIONAL INFORMATION:

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Scope of products: combination products and Biosimilars (mechanical devices, almost no electronic devices)
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Team work in cooperation with Risk Management, Device Technology, Primary Packaging and Testing teams.
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2-3 Projects per HFE
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Team: 14 Persons

REQUIREMENTS:

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min 2-3 years of experience in Human Factors
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Ideally experience with combination products
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Also good: if person has experience in other highly regulated areas such as Aeronautic, Nuclear, and their respective Quality Systems
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high flexibility needed
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candidate must be a good negotiator, presenter, communicator and be convincing

To learn more about this opportunity please send your CV ASAP in Word format to BRINE SA.

WORK LOCATION: Basel

START: 01.01.2019

DURATION: 6 months +

WORKLOAD: 100%

SALARY: Local Market rate according to experience

PERMIT: EU permits

LANGUAGE: English

REF. NR.: EW2550

BRINE SA has been providing its IT- and SAP specialists for short-, mid- and long-term projects in Switzerland since 1985, with customers primarily active in the following market sectors:

Financial services sector, especially banks and insurance companies

Pharmaceutical industry

Government and services sectors

BRINE SA is a stable, financially independent, Swiss enterprise with its head office in Zurich. Our services cover the entire IT spectrum, as well as interfaces to the various business sectors, and range from management- and IT-consulting through to software development and project implementation.

IT - RESOURCES

We offer our top consultants, computer Profi's and SAP experts to our customers as external specialists for limited assignments and as well for permanent positions.

BRINE SA is especially distinguished by its renowned characteristic strengths:

Short reaction time - rapid selection and supply of consultant's CVs, with skills matched to customer requirements.

Quality - we take quality very seriously, both for internal and external-facing processes, thereby convincing many customers to maintain a long-standing business relationship with BRINE SA

Coaching - BRINE SA coaches and supports its consultants throughout the entire duration of the customer assignment.

BRINE SA is ISO 9001:2008 certified since 2014

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    6 months+

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

BRINE SA