Principal Quality Engineer

What you'll do

• Create and maintain the risk management file, including plans, reports, and regular risk reviews.
• Lead hazard and risk analysis activities to identify potential risks and implement control measures.
• Lead Design Failure Modes and Effects Analyses (DFMEAs) with project teams to evaluate failure modes.
• Integrate product security measures into the risk management file to protect against vulnerabilities.
• Develop and manage post-market surveillance plans to monitor product performance and safety in the field.
• Perform root cause analysis and lead field issue evaluations during initial product launches.
• Ensure traceability between the risk management file, requirements, and design outputs using tracking tools.
• Oversee design validation and verification activities including test plans, protocols, and results documentation.

What we're looking for

• Minimum bachelor’s degree in engineering or a related technical field.
• Advanced degree is preferred.
• In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards.
• Experience in the medical device industry and regulated engineering fields.
• Proficiency in quality management systems, risk management, regulatory compliance, and statistics.
• Strong analytical problem-solving skills to conduct thorough root cause analysis.
• Excellent written and verbal communication skills for cross-functional collaboration.
• Work authorization at the time of hire and for the duration of employment.