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Systems Engineer




Job description:Responsible for end-to-end product life cycle management including creating and maintaining user requirements, product requirements, risk files, establishing and publishing traceability, and providing support to PGS on-market product support and maintenance for new products, under the coaching of a senior member on the team.Responsible for documentation generated in support of product development and submissions, and may also be responsible for on-market product documentation.Determines the DHF Structure and Owns the Requirements and Risk Management File.Responsible for DHF content generation in support of regulatory submissions with compliance to governing procedures and CFR 820.30 and CFR Part 4 Combination Products.Partner with other functions and Human Factors in the organization to ensure user errors or misuse are mitigated, stakeholders' requirements are addressed and met as appropriate; to provide consistent direction to cross functional teams and to instill a spirit of collaboration throughout the organization.Integrates multiple approaches to solve problems or optimize solutions in complex or cross functional manufacturing processes or product designs. Creates/modifies subsystems' designs for complex problems.Integrates subsystems and components in total systems designs; develops specifications from customer requirements.

Posted 23 days ago

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