Direct message the job poster from IQVIA Italia
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 solutions to optimize the user experience with products that improve 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 according 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's responsibility and accountability.
The candidate will be responsible for 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 principles and main activities related to design development (e.g., product risk management, product requirements definition, testing activities (DVT), equipment validation (IQ,OQ,PQ), etc.)
REQUIREMENTS:
* Degree in biomedical engineering, design, HFE, or other similar fields
* Two or more years of professional experience in the HFE and ideally in the development of medical products
* 5 or more years of professional experience in design and 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 a plus
* Knowledge of the applicable standards: IEC 62366, FDA HFE guidelines, ISO 13485, ISO 14971
* 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
TYPE OF CONTRACT:
Permanent contract
Chemical contract
#J-18808-Ljbffr