Quality Engineer

4 settimane fa

Pisa, Toscana, Italia Mmi - Medical Microinstruments, Inc. A tempo pieno

Want to join a motivated team of 220+ people who are dedicated to improving patient care through surgical robotics?
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.The RD Design Quality Engineer will provide support for new product development, design changes and sustaining engineering including technical documentation creation and updates, testing evidence and review and documentation needed for certification and projects advancement accordingly with quality procedures.Knowledge of structured process for new product development, including gates and deliverables, and knowledge of relevant standards is expected, together with experience in optimization and validation of test methods.The candidate will help develop, establish and maintain quality engineering methodologies, systems, and practices which meet QMS standard operative procedures and regulatory requirements and she/he will have the opportunity to work within a high calibre multidisciplinary team.Roles ResponsibilitiesParticipate in development teams to support the new product design, design changes, material testing, product requirements and product specification preparation, traceability and maintenance, qualification protocols, technical documentation update and review.Support RD team in generation, review and update of documentation needed accordingly with Projects Gates and MMI Quality procedures.Coordinate and support testing and experiments, including validation planning.Assist troubleshooting on product/process problems as related to design, material or process.Collaborate cross-functionally to support completion and maintenance of product risk management deliverables to establish and maintain safe and effective products and processes.Summarize, analyze, and draw conclusions from test results or events to assess tech risk and product risks, to establish actions and maintain safety and effectiveness of products and processes.Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.Act as an effective RD team member in supporting quality disciplines, decisions, and practices including tech prototype input, review and test, mfg process.RequirementsLevel qualification from an engineering background (Mechanical or Biomedical).Knowledge of industry practices and working knowledge of Medical Device regulations.Knowledge of structured process for new product development toward certification.Experience with ISO 14971 Risk Management and ISO 13485 Quality Management Systems.Experience with 21 CFR 820.30 Design Control.Good technical writing skills.Fluent business English.Ability to collaborate effectively in a team environment.PreferredGood knowledge and experience of EU and FDA regulations.Inter-disciplinary understanding of robotics, electronics, software and control.General knowledge and application of technical and business concepts, procedures and practices.Ability to influence decision of others.About MMIMMI 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 offerAn 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 UsAre 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 energetic people who will motivate and inspire youInterested?
We would love to hear from youMMI 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.
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