Principal/Sr Principal Quality Engineer

Responsibilities:

• Oversee design assurance and development tasks for New Product Development, including risk evaluations, engineering studies, feasibility assessments, drawing analysis, and statistical evaluations.
• Ensure compliance with relevant regulatory frameworks, such as FDA, EU MDR, and ISO standards, across all stages of product development.
• Create and validate advanced experiments and testing protocols to enhance product design and manufacturing processes based on engineering principles.
• Identify and address quality and regulatory concerns throughout the product lifecycle, providing detailed analysis and reports prior to product launch.
• Evaluate and audit suppliers to verify materials and components meet strict quality standards, implementing corrective actions as required to ensure compliance.

Qualifications:

• Bachelor's degree in Engineering or a related field; advanced degree preferred.
• At least 7 years of quality engineering experience in the medical device industry, ideally in cardiac ablation or structural heart technologies.
• Expertise in quality assurance, control, and process optimization, with strong proficiency in tools like FMEA, CAPA, SPC, Six Sigma, and Minitab.
• Strong analytical and problem-solving skills, including experience with root cause analysis and corrective action.
• Hands-on experience with validation processes (IQ/OQ/PQ), product testing, and statistical methods.
• Proven success in leading quality initiatives and driving continuous improvement, with a focus on risk management and compliance.
• Excellent communicator, capable of working effectively with cross-functional teams, suppliers, and regulatory agencies.

For any questions please reach out to adam.tizabi@epmscientific.org to learn more about this oppurtunity!