Human Factor Engineer

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 Engineer who can join an exciting working environment in a dynamic and international atmosphere.

JOB DESCRIPTION:

The candidate will be responsible for designing new products by defining user requirements and translating them into solution to optimize the user experience with products that improves patient lives.

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.

The candidate will be leading the preparation of task analysis formative and summative study documentation known use errors documentation usability risk assessment HF plan and final reports. All the Human factors file index will be the candidate responsibility and accountability

The candidate will be responsible of integrating the HF stream and correspondent documentation into the design development management (from feasibility to life cycle management). Therefore the candidate should be knowledgeable of design control principle and main activities related to design development (e.g. product risk management product requirements definition testing activities (DVT) equipment validation (IQOQPQ) etc.)

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:

• National Collective Labour Agreement: Chemical and Pharmaceutical Industry
• Contract Type: Permanent
• Salary Range or Gross Annual Salary: Minimum salary foreseen for the role starting from 46.800 gross per year.

The role also includes:

a variable bonus/MBO ranging between 5% and 8%;

private health insurance (please note that this is not the one provided under the National Collective Labour Agreement for the Chemical-Pharmaceutical sector);

pension fund (please note that this is not the one provided under the National Collective Labour Agreement for the Chemical-Pharmaceutical sector);

flexible benefits/corporate welfare.

The salary range is defined based on experience skills and internal equity criteria.

Career progression and compensation review are based on transparent objective criteria.

We are committed to fair and equal pay practices in line with applicable pay transparency regulations (EU

Directive 2023/970).

IQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request. Applications WITHOUT the requirements Will NOT be fully taken into account. Please enter the authorization for the processing of personal data (DL196/2003) - General Data Protection Regulation (13 GDPR 679/16 ) to IQVIA and to transfer those data to IQVIAs Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).

#LI-CES #LI-DNP

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