Want to join a motivated team of 100+ people who are dedicated to improving patient care through surgical robotics? Interested in working in the fast-paced, medical device industry? MMI is looking for people with a passion for innovation and a dedication to excellence.
MMI is seeking a Product Lifecycle Management Specialist that will be responsible for Product Configuration Control and the effectiveness of Design Control and Change Control processes. He/she will improve, maintain and enforce a solid product configuration management process and provide support to specialist teams to embed these processes into PLM, ensuring also that technical and quality documentation is managed in compliance with internal procedures.
· Product Configuration Management
o Responsible for the enterprise Product Life Management System configuration / validation, workflow creation.
o Collaborate with the project design / build team in support of multiple, concurrent configuration baselines in line with the CM Plan.
o Manage user permissions and security access.
o Participate in Design Reviews throughout the New Product Introduction process.
· Design Control
o Works with R&D department on continuous improvement of the Design Control.
o Support engineering teams for preparation of NPI Design Reviews.
o Uses Design Control guidelines to coordinate the flow and completion of documentation associated with Design Reviews.
· Change Control
o Support engineering teams for preparation of Engineering Change Notices.
o Track and flag changes with recurring obligations, expiration dates, execution requirements and communicate deliverables or time sensitive information to internal employees.
o Coordinates with other departments in facilitating ECNs and tracks to ensure that they are complete in a timely manner for all product changes.
· Document control
o Create filing structure including document classes, sub classes, naming convention, and regularly maintain the order and organization of QMS and product related files in the company Documentation Control tool.
o Maintain and improve document control procedures.
o Develop new document structures and templates.
Qualifications & Requirements:
· Must have
o Degree level qualification from a science/engineering background.
o 3+ years hands-on working experience of Configuration Management and technical documentation within a systems engineering Technology Company (Biomedical, Electronic, Automotive, Defence, Aerospace), including electrically and SW based product.
o Deep Knowledge of at least one PLM tool (Oracle Agile, Arena, PTC Windchill, etc.l).
o Proficiency in MS Office Excel, Outlook, Word.
o Business fluent English skills.
· Nice to have:
o Knowledge of requirements for Quality Management System for Medical Devices (21 CFR part 820, ISO 13485).
o Experience with ISO 14971 Risk Management.
o Experience with IEC 60601 Medical Electrical Equipment, ISO 62304 Medical Device SW and ISO 62366 Usability.
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 ability to learn new skills under the direction of the VP RA/QA with career advancement opportunities.
According to your experience and responsibilities we will give you;
· Inclusive Welfare Plan;
· Ticket restaurant
· Company bonuses;
· Training plan;
· Work-life balance encouraged
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!