Senior Human Factor Engineer

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.

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:

Permanent contract

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 IQVIA’s Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).