Qualified candidates must have a strong understanding of IEC62304.
Please see the requirements below. If interested in this opportunity, please send me the latest copy of your resume and we can discuss the role further.
PURPOSE AND SCOPE:
Participate in software development and verification in New Product Development and design changes. Ensure all software for functional completeness, internal design control procedures and regulatory compliance.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
• A seasoned, experienced professional with understanding of IEC62304, ISO14791, and design control process; resolves a wide range of issues in creative ways.
• Work with project managers and cross functional team to ensure products meet customer expectations, and regulatory requirements.
• Provide guidance to engineering staff to ensure SDLC and design control requirements are being met in an effective manner, including full range design verification, validation, risk management, and design review.
• Review requirements, specifications and technical design documents to provide timely and meaningful feedback.
• Drive risk analysis and FMEA deliverables with engineering staff to ensure product safety and efficacy.
• Review test protocols and reports at multiple levels to ensure the accuracy and completeness of test cases.
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