Develop verification and validation protocols and reports, applying advanced statistical techniques and ensuring compliance with global regulatory requirements.
Establish, review and maintain Design History File documentation, including design requirements, specifications and design outputs, ensuring inspection readiness.
Core team member of design change control activities, assessing product and process impacts while ensuring compliance and patient safety.
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Manage the engineering activities during new product introduction including product test flow, EVT and DVT engineering activities, generation of buyoff units, and test program readiness before ramping to volume manufacturing.
Manage product ramp to yield entitlement. Drive all margin issues with operations and development teams.
Responsible for technical/administrative/operational leadership of a project/mission within the programmatic guidelines set by the program manager and customer.
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