Mechanical Engineer DDS
1 settimana fa
We are seeking a highly skilled Sr. Mechanical Engineer to join our Design Center for Drug Delivery Systems in Milan, Italy.
Role Overview
The successful candidate will be part of a dynamic and growing team of medical devices engineers, responsible for the development of proprietary devices for Stevanato Group.
Key Responsibilities
- Develop and lead the mechanical design of drug delivery devices from concept to production.
- Collaborate with cross-functional teams to ensure seamless product development and industrialization.
- Work closely with external design agencies and suppliers to ensure timely and cost-effective delivery of components.
- Ensure compliance with regulatory requirements and industry standards, including ISO 13485, ISO 11608, and FDA/EMEA guidance documents.
Requirements
- 5-10 years of experience in end-to-end product development, with a focus on heavily regulated markets (Medical/Automotive/Aerospace).
- 5+ years of experience with plastic component and mechanism design.
- Strong fundamentals in mechanical design, including design for manufacturing, material selection, and tolerance analysis.
- Hands-on experience with mechanical modeling and simulation, including FEA and kinematic analysis.
- Proficiency in CAD systems, such as CREO/Solidworks.
- Experience with New Product Introduction processes and risk analysis techniques (FMEA, Fault Tree Analysis, etc.).
- Fluent in oral and written English.
Preferred Qualifications
- Prior experience in Medical device and drug delivery devices.
- Knowledge of regulatory and standard guidelines, including ISO 13485, ISO 11608, and 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.
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