California Licensed Design Assurance Engineer
VirtualVocationsSpringfield, Massachusetts, United Statesjob_description.job_card.variable_hours_ago
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- serp_jobs.job_card.full_time
job_description.job_card.job_description
A company is looking for a Staff Design Assurance Engineer (Hybrid).
Key Responsibilities :
Lead Design Control and Software Development initiatives for FDA Class II and Class III medical devices
Ensure compliance with IEC 62304 and FDA Guidance on software submissions
Support cybersecurity risk management and validation of software tools
Required Qualifications :
BS degree in engineering, scientific, computer systems, or quality management; Master's preferred
Minimum of 8 years of experience in Software Quality Engineering in a regulated environment
Experience with medical device software development and risk-based validation
Familiarity with FDA 21 CFR Part 820 and ISO 13485 quality system standards
Working knowledge of IEC 62304, ISO 14971, and related guidance documents
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Design Assurance Engineer • Springfield, Massachusetts, United States
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