On behalf of 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 a global pharmaceutical company - IQVIA is looking for a Senior Human Factor Engineer who can join an exciting working environment in a dynamic atmosphere.
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Role 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.
The candidate 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 candidate 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 under the candidate responsibility and accountability.
The candidate will be responsible for preparing the Human Factors submission file, ensuring alignment with regulatory expectations and compliance with FDA, EMA, and other applicable authority guidelines. The candidate will participate in the review process with regulators.
The candidate will be responsible of integrating the HF stream and correspondening 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), etc.)
Qualifications:
Degree in biomedical engineering, design, HFE or other similar fields
Two or more years of professional experience in the HFE and in the development of medical products
5 or more years of professional experience in design and development of medical products
Knowledge of user-centred 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 in communications with regulatory bodies
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
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. xpavfwm 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 IQVIA's Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).