Device Specialist

3 settimane fa

Parma, Italia Chiesi Farmaceutici A tempo pieno

Device Specialist - Maternity Leave
Date: Feb 6, 2023
Department: GTD Global Technical Development

**Job Type**: Direct Employee
Team: R&D, Pharmacovigilance & Regulatory Affairs
Contract Type: Temporary

**Location**:
Parma, IT

Main Responsibilities

Experience Required

one or few years of professional experience in the HFE and ideally in the development of medical products

Education

Degree in biomedical engineering, design, HFE or other similar fields

Languages
- Fluent in spoken and written English
- Fluent in spoken and written Italian

Technical Skills
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.
Soft Skills
Communication skills
Planning and organizational skills
Quality orientation
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