Job Description

Responsibilities:

• facilitate the creation of both top-down and bottom-up risk management tools, assessments, processes, and principles, including FMEAs.
• Analyze existing similar products from the company and competitor products to provide documented compliance and evidence of State of the Art, as part of periodic risk management file updates.
• Assure products meet regulatory requirements for risk management, including FDA QSR, MDD, EU MDR, CMDR, ISO 13485, ISO 14971, and Philips procedures.
• Ensure the systematic and logical conversion of customer requirements to product specifications and post market surveillance codes.

Qualifications:

• BS in Engineering or a related field. MS preferred.
• 6+ years Quality Assurance, Design Engineering, Systems Engineering, Post Market Surveillance, or related experience in a highly regulated industry.
• 2+ years experience with a MS or higher.
• Extensive hands on experience with the ISO 14971 standard.
• Knowledge of 21 CR 820, ISO 13485, IEC 60601-1, IEC 62366, and IEC 62304 standards.

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