Design Authority
3 settimane fa
We are looking for a **Design Authority** to be inserted in our Design Engineering (ITA) team in Milan.
She/He wiill be part a of the Drug delivery system (DDS) Team, an experienced and growing team of medical devices engineers that leads the development of proprietary devices for Stevanato Group.
She/He will works in a fast-paced international and multi-disciplinary team within an entrepreneurial environment where it is possible to transform good ideas into real products, getting into the details without losing the big picture.
**Responsibilities**:
- Has the overall technical leadership of the design and production topics with full systems product release during concept and development phase
- Is the main technical contact person and is responsible for the requirement definition, he/she leads, coordinates and participates in all technical development activities from early-stage concept definition to final V&V
- Is accountable for the traceability and documentation in development under consideration of design control aspects
- Creation and regularly update of the design history file (DHF)
- Supports the human factor (HF) and risk management team (RMF) with activities and documents
- Facilitates change control and design changes during development
- Coordinates the design of the system architecture, taking into consideration the device physical constraints and target performance
- Supports the project managers to set the design strategy, priorities and the project timeline, delivers development results according to the plan
LI-DNI
**Qualifications**
Minimum Qualifications
- 8-10 years experiences with complex medical devices development, if applicable in combination with glass, in particularly regarding direct drug contact (combination product), and/or in combination with electromechanical components and software and hardware from concept to production
- Experience in track-record during medical device development and Software Design in heavily regulated markets (Medical/Automotive/Aerospace).
- Can perform risk analysis following ISO 62304, 14971 and relevant FDA guidance documents
- Prior experience in working in a group of engineers and or external consulting companies on a global level
- English on a negotiation level
Preferred Qualifications
- Knowledge of regulatory affairs, standards and guidelines such as: ISO 62304, ISO 13485, ISO 11608, ISO 14971, ISO 10993, ISO 26800, FDA/EMEA guidance documents
**Adherence to Stevanato Group’s Values**: Trust and respect everyone; Be accountable; Be ethical, always; Listen and communicate with transparency and honesty; Deliver results
**About Us**
We are a dynamic organization with great customers and a culture where people are valued and empowered to deliver amazing results. We are also growing and looking to hire talented and passionate individuals to join our team
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