Quality Development Engineer
Descrizione dell'offerta
Want to join a motivated team of 220+people who are dedicated to improving patient care through surgical robotics? Interested in working in the fast-paced medical device industry?
Medical Microinstruments Inc is looking for people with a passion for innovation and a dedication to excellence.
At MMI we are building the future of microsurgery. The Symani platform provides the surgeon with the capability to operate on a small scale with ease and precision, thanks to the Symani platform and a variety of Instrument types.
For our Quality Development Team , we are seeking a dedicated and detail-oriented Quality Development Engineer. In this role, you will play a crucial part in sustaining NPI projects from a Design Control standpoint.
Role Purpose:
- Support the maintenance of user requirements, product requirements, product specifications and the traceability between product requirements, design and test items.
- Collaborates cross-functionally to support completion and maintenance of product risk management deliverables to establish and maintain safe and effective products and processes.
- Support the engineering team for developing verification test plans and reports
- Review of design control deliverables in compliance with IEC 80601-2-77, IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-2
- Support development of DHF to ensure content is complete, accurate, and compliant with regulatory standards.
- Support quality system-related deliverables, including nonconformances and CAPAs
- Perform other related duties and responsibilities, as assigned.
Job Requirements:
- Degree level qualification from a science/engineering background
- Experience working with class IIa / IIb Medical Devices
- Deep knowledge of ISO 13485
- Experience with ISO 14971 Risk Management
- Deep knowledge of IEC 60601* standards
- Basic knowledge and experience of EU and US regulations
- Business fluent English skills (B2 at least)
- Good technical writing skills
About MMI
MMI is dedicated to improving reconstructive options for surgeons and patients and has developed the first teleoperated robotic platform for open microsurgery. It offers the surgeon motion scaling and tremor elimination and aims to facilitate existing procedures as well as enable new ones in the domain of microsurgery, from post-oncological and trauma reconstructions to ophthalmology, organ transplantation and pediatric surgery.
What we offer
An exciting and challenging role based in Pisa, Italy. Working in a fun and growing company that is dedicated to improving patient care. The chance to learn new skills under the direction of experienced colleagues with career advancement opportunities.
Join Us
Are you seeking an opportunity to make a real difference in a med-tech company with the aim of improving patient care?
Join us and grow with a team of energy people who will motivate and inspire you!
Interested? We would love to hear from you!
MMI is committed to creating a diverse work environment and is proud to be an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, pregnancy, age, disability or other characteristics protected by law.