Design Assurance Engineer

New Yesterday

Responsibilities: Ensure compliance with the Quality System and applicable GMP/ISO standards.
Lead design assurance activities for electromechanical systems with microcontrollers, PCBs, and software components.
Manage Design History Files (DHF) for new products.
Define product requirements in collaboration with key stakeholders.
Develop and execute test plans, protocols, and reports.
Perform and support verification/validation testing, including in vitro and animal studies.
Conduct risk management activities including FMEA.
Define supplier quality specifications and support sterilization method validation.
Lead continuous improvement initiatives and support ECO reviews. Requirements: Bachelor's degree in engineering or related technical field.
Strong understanding of quality system regulations (GMP, ISO ).
Experience with risk analysis, verification/validation, and electromechanical systems.
Familiarity with regulatory requirements and design control processes.
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Location:
Plymouth

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