RESPONSIBILITIES
* Work closely with R&D to assess and influence product designs for quality, reliability and regulatory compliance.
* Evaluate schematics, PCB layouts and hardware specifications to identify potential design-related quality risks and ensure robust engineering standards are met.
* Lead design risk assessments (e.g., DFMEA) and support root cause analysis for design-related issues.
* Support NPI validation and verification strategies.
* Support Purchasing team and R&D teams with New Vendor and part approvals processes with a focus on ensuring quality is maintained.
* Statistical analysis and reporting of parametric test data.
* Support software and hardware testing from a quality perspective.
* Provide technical support to Production, Test departments and Process Quality Engineers in resolving product-related issues, ensuring effective communication between R&D and operations.
* Ensure traceability and compliance with regulatory and internal standards.
* Drive continuous improvement in design processes and quality metrics.
* Act as a technical quality representative in design reviews and product development meetings.
* Support audits and regulatory inspections related to design controls.
REQUIREMENTS
* Bachelor’s Degree in engineering (Electronic, Electrical, Software, or related).
* 5+ years in a Quality or R&D role within a regulated industry (e.g., medical devices, aerospace, automotive, life safety).
* Strong understanding of product development, lifecycle and design controls.
* Experience with hardware/software integration and testing.
* Familiarity with ISO 9001, or similar standards.
* Ability to read and understand electronic schematics and circuit designs.
* Experience with FMEA, risk management and root cause analysis tools.
* Knowledge of embedded systems, firmware, or software development.
* Strong communication and cross-functional collaboration skills.
* Ability to interpret technical drawings, specifications, and test data.
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