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!
