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Senior Staff Engineer, Design QA
A company is looking for a Senior Staff Engineer, Design QA, Hardware and Embedded Software Systems. Key Responsibilities Lead Design Assurance and Quality Engineering activities for new product development involving Hardware and Embedded Software Systems Provide oversight for Design History File deliverables and ensure compliance with relevant standards and regulations Support quality-related process improvements and provide technical expertise throughout the Development Lifecycle Required Qualifications BS degree in Electrical Engineering, Mechanical Engineering, Systems Engineering, Physics, or a related field A minimum of 8 years of experience in Design Assurance/Quality/Product Design within a regulated environment Expertise in Design Controls (FDA 21 CFR Part 820) and Medical Device regulations (IEC 62304, ISO 14971) Proven ability to deliver successful products to market and collaborate in cross-functional teams Master's degree and quality certifications (ASQ, CQE) are preferred
A company is looking for a Senior Staff Engineer, Design QA, Hardware and Embedded Software Systems.
Key Responsibilities
Lead Design Assurance and Quality Engineering activities for new product development involving Hardware and Embedded Software Systems
Provide oversight for Design History File deliverables and ensure compliance with relevant standards and regulations
Support quality-related process improvements and provide technical expertise throughout the Development Lifecycle
Required Qualifications
BS degree in Electrical Engineering, Mechanical Engineering, Systems Engineering, Physics, or a related field
A minimum of 8 years of experience in Design Assurance/Quality/Product Design within a regulated environment
Expertise in Design Controls (FDA 21 CFR Part 820) and Medical Device regulations (IEC 62304, ISO 14971)
Proven ability to deliver successful products to market and collaborate in cross-functional teams
Master's degree and quality certifications (ASQ, CQE) are preferred