- Key member of the R&D Systems Engineering team
- As Design Transfer Lead for our acute dialysis machines, you will act as the interface between the global R&D organization and Manufacturing plant (Italy).
- Primary lead in coordinating the design transfer of products' changes into production specifications and processes.
- Accountable to maintain and defend the Design History File (DHF)/ Device Master Records (DMR) in plant audits and to enable Product Design Lifecycle Management (PDLM) process, acting as the delegate Product Design Owner (PDO)
- Develop technical expertise in the respective product family and in-depth knowledge supporting the finished product design such as, but not limited to:Products' essential requirements/specifications and design controlsCompliance/Regulatory informationManufacturing processes and manufacturing locationsAssigned product families Risk Management Files, author of pFMEA
- Skilled in the operation of key databases used for Quality Systems with appropriate roles assigned in those applications (e.g., TW8, TcU).
- Independently plan and implement a series of design and/or technical tasks that may not be well-defined, have multiple variables, and require advanced implementation techniques.
- Play a lead role in the evaluation, selection, and adaptation of various techniques, which accomplish business objectives such as quality and cycle-time.
- Routinely provide advice and assistance to team members regarding unique problems.
- Devise innovative approaches to sophisticated problems through adaptations and modifications of standard technical and design principles. Incorporate new methods and technologies for improving existing or new products/processes.
- Maintain focus on meeting both external and internal customer expectations.
- Effective collaboration and adaptability with internal team members and external colleagues in different sites and different time zones (US, India, China). Influence others internally and externally. Ability to negotiate.
- Strong engineering background with at least Bachelor's Degree (Electrical, Mechanical, Biomedical, etc...).
- Minimum of 3-5 years' experience in medical device development or equivalent
- Knowledge of the medical device industry and relevant standards (e.g. ISO 13485, IEC 60601, MDR)
- Hands-on experience using Product Lifecycle Management (PLM) tools
- Understanding of system design of electromechanical product
- Some leadership experience
- Fluent english knowledge
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Systems Principal Engineer - Medolla, Italia - Baxter
Descrizione
Vantive: A New Company Built On Our Legacy
Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.
At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
Summary
This is a Systems Principal Engineer, Design Transfer Lead position. We're the team working to save and sustain lives everyday collaborating colleagues from around the world and creating solutions for our global fleet of medical devices. We work with the hardware and software engineering teams, as well as cross-functional stakeholders to turn phenomenal ideas into reality. Come join us in making a difference
What you'll be doing
What you'll bring
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