Human Factor Device Development

3 settimane fa

Milano, Italia IQVIA A tempo pieno

Our client, **Chiesi Farmaceutici **- one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry - in order to expand their staff, entrusted to IQVIA the recruitment of a **Human Factor Device Development **who can join an exciting working environment in a dynamic and international atmosphere.

**JOB DESCRIPTION**:
He/She will be responsible for defining the Human factors strategy to support the human factors engineering files and to achieve designing products that increase loyalties and satisfaction of the final users (customers/patients/HCPs). The Human factors process will have to be developed accordingly to regulations and ISO standards requirements ( ISO14971, IEC 62366, FDA HFE guidelines).

The profile will be responsible for managing external partners that will be responsible for carrying out the Human factors studies also supporting the design of the testing based on a risk-based approach.

**REQUIREMENTS**:

- Degree in biomedical engineering, design, HFE or other similar fields
- One or few years of professional experience in the HFE and ideally in the development of medical products
- Knowledge of user-centered design and usability engineering principles to product research,
- development and design
- Experience with generating documentation in support of the HF usability engineering activities (usability requirements, URRA, HF study related documentation) for medical products
- Confident in collaborating and communicating with internal and external multidisciplinary teams (including engineering, marketing, clinical, regulatory, quality and drug product experts)
- Experience with all phases of the product development life cycle within the medical device industry
- under a strong QMS
- Experience in working with HCP is considered as a plus
- Knowledge of the applicable standards: IEC 62 366, FDA HFE guidelines, ISO 13 485, ISO 14 971
- Knowledge of design control guidance under FDA and MDR.
- Good communication and organizational skills
- Ability to work in a complex environment both independently and in a team
- Fluent in spoken and written English
- Fluent in spoken and written Italian

**TYPE OF CONTRACT**:
Permanent contract

Chemical contract

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