- She/He will 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 have the opportunity to work in a fast-paced, international and multi-disciplinary team within an entrepreneurial environment where it is possible to transform good ideas into real products.
- She/He will lead all activities related to the design for one (or more) of the current device portfolio.
- She/He will be the glue between all team members: he/she analyses and understands complex systems and lead a technical team to a successful development. Understands different technical languages (Quality, Regulatory, Risk Management, Testing, Manufacturing) and can provide insights in all development areas (Mechanics, Electronics, Software, Algorithms, Usability)
- She/He will be the main technical point of contact of internal (Project Team, QA/RA, Manufacturing Site, Product Management, Business Development) and external stakeholders (Contract Development Organizations, Clients, Suppliers).
- Leads the technical development project team assigned, balancing priorities, addressing all the technical aspects to ensure that all the phases are properly achieved as well as delivers the solution expected in line with user needs and design input requirements, working with the other functions involved.
- Ensures the adherence of design inputs with design output, prototype solutions and provides guidance during all feasibility and development phases, acting as technical reference with the Customers technical team.
- Drives the project team involved throughout stage and gates product development process from early feasibility, ensuring the design is suitable for the successful transfer at the industrial scale manufacturing.
- 5-10 years of experience in end-to-end product development - from early design stage to mass production in heavily regulated markets (Medical/Automotive/Aerospace).
- 7+ years ofexperience with plastic component and mechanism design.
- Solid fundamentals in different areas of technical product development (hardware, software, human factor, requirement management)
- Experience with New Product Introduction processes.
- Experience with common Risk Analysis techniques (FMEA, Fault Tree Analysis, etc).
- Prior experience coordinating small group of engineers and or external consulting firms.
- Fluent in oral and written English.
- Prior experience in Medical device and drug delivery devices
- Knowledge of regulatory and standard guidelines such as: ISO 13485, ISO 11608, ISO 10993, ISO 14971, FDA/EMEA guidance documents.
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Technical Leader DDS - Milan, Italia - Stevanato Group
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Descrizione
Job Description
We are looking for a Technical Leader to be insert in our Technical Development Drug Delivery System team. The candidate will be based in our Milan (IT) office, directly reporting to the Function Manager.
Role Introduction
Responsibilities
#LI-DNI
Qualifications
Preferred Qualifications
Adherence to Stevanato Group's Values : Trust and respect everyone; Be accountable; Be ethical,
always; Listen and communicate with transparency and honesty; Deliver results.