Job Description
We are looking for a Design Authority to join the R&D team in our Drug Delivery System & IVD Business Unit, with openings in both our Piombino Dese (PD) and Milan offices.
In this role, you will have the opportunity to collaborate to the development, industrialization, and scale-up of the Device component of a Combination Product, in a multidisciplinary design centre with design, human factors and quality assurance engineers, risk managers, regulatory affairs and program management, collaborating closely with internal and external stakeholders.
You will be responsible for collecting all stakeholders’ requirements, including end users, and translating them into detailed design inputs. You will own and maintain the Design History File (DHF) throughout the product lifecycle, ensuring full traceability from requirements to design outputs and verification/validation (V&V) activities, in compliance with the product development and design control processes, the Quality Management System, the regulatory requirements, and applicable standards.
Key Responsibilities
1. Translate business and customer needs into technical design inputs and liaise with the Design Engineers to find appropriate design solutions.
2. Align all department involved into the project to maintain a consistent DHF.
3. Lead Verification & Validation activities, support design transfer, and manage design changes
4. Decompose products into functional, physical and component architecture for systemic requirement engineering and traceability.
5. Act as primary technical contact for internal and external stakeholders
6. Lead product lifecycle management (sustaining engineering).
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Qualifications
7. 7+ years in medical device product development in a design, R&D quality, regulatory, V&V or life-cycle management role.
8. Engineer or Technical Master’s degree (or equivalent experience)
9. Strong leadership, problem-solving, analytical thinking, communication, and risk-based approach
10. Knowledge of product development and design control of combination products (or design constituent components) and manufacturing technologies such as plastic injection molding or automated assembly
11. Familiarity with FDA 21 CFR 820.30, ISO 13485, ISO 11608 and IEC 60601. Familiarity with ISO 62304 and IEC 62366 is a plus.
12. Knowledge of GMPs, cGMPs, FDA guidelines, MDR 2017/745
13. Knowledge of Risk management (e.g., FMEA) per ISO 14971 and QMS processes
14. Familiarity with requirements engineering and traceability input-to-output.
15. Experience with FDA submissions for injectables with combination devices is a plus.
16. Familiarity with project management methodologies is a plus.
17. Ability to work in complex, time sensitive product development projects and with a collaborative spirit.