The Role ProfileThe Product Quality Engineer will serve as a critical interface between the Quality and R&D teams, ensuring that product designboth hardware and softwaremeets quality standards from concept through launch, while also providing long-term sustaining support. This role requires strong technical acumen, hands-on engagement with product development, and a proactive approach to risk mitigation and design assurance.The role also involves supporting Process Quality, Production, Test Engineering, and R&D teams in resolving product-related issues, particularly those involving hardware and firmware functionality and design integrity.Key ResponsibilitiesWork 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.Qualifications & ExperienceBachelors 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.Skills & CompetenciesAbility 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.SkillsElectronic Engineering Quality ISO 9001 Hardware/Software Integration Software Testing