Vacancy expired!
EG Life Sciences has a client in the Medical Devices Industry looking for a senior-level Systems Engineer to help lead the creation and integration of product designs in support of product development, manufacturing transfers and investigations, supplier driven design changes, and product enhancements.
This is a high level consulting role that is expected to last 12+ months.Much of the work can be done remotely, however the consultant will be required to go onsite for critical duties and projects.Our Client is looking for:- Expertise in design and development processes that conform to standards including IEC 60601, ISO 14971, IEC 62304, 11608, 62366 and the ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820 and EU MDR.
- Must have experience in user and stakeholder need definition; requirements definition; requirements cascade; risk management, product architecture, reliability, system modeling; V&V
- Ability to independently lead application of systems engineering concepts and practices in development and maintenance of medical devices
- Risk management planning, analysis and reporting experience
- Strong analytical and communication skills, specifically writing structure requirements
- BS Engineering with at least 12 years related work experience, MS Engineering with at least 10 years of related work experience, PhD Engineering with 4 years of related work experience
Vacancy expired!