Senior Design Assurance Engineer

Our Company

Gentuity is an exciting and highly innovative medical technology firm, active in the research and development, clinical translation, and commercialization of vascular imaging devices. This opportunity provides the candidates the unique chance to work on innovative medical products, with the potential to significantly change the practice of medicine in the care of patients suffering from a wide range of highly debilitating vascular diseases.

This role will be responsible for ensuring the new products and design changes to existing products meet regulatory and quality requirements throughout the design and development process. This will be accomplished through collaboration with cross-functional teams performing verification and validation , process development activities, product risk management requirements and product reliability activities.

Your Responsibilities Include
• Lead and support new product development design control deliverables for software/hardware product development or design/process changes.
• Actively participate in risk analysis including FMEAs, hazard analysis and other risk management file requirements
• Maintains and audits Design History Files.
• Support Process/Design Validation/Verification activities including software validation, IQ/OQ/PQ activities.
• Provide quality and compliance support during regulatory audits and responses to government agency questions.
• Lead CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating, and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies).
• Responsible for the review and approval of manufacturing verification and validation protocols and test reports.
• Participate in the design control and review processes, including quality planning.
• Perform quality driven statistical analysis.
• Perform other duties as assigned to support the advancement of the QMS and product manufacturing.

Experience / Qualifications
• Minimum of a bachelor’s degree in science, engineering, or other related technical discipline.
• Minimum of 10 years of experience with engineering and development of electro-mechanical devices with product software installed.
• Stong understanding in medical device design controls and risk management regulations such as ISO 13485, FDA 21 CFR 820.30, MDR (EU) 2017/745, ISO 14971, 60601,
• Knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required.
• Experience with capital equipment or optical imaging technology preferred.
• ASQ Certified Quality Engineer (CQE), preferred.
• Able to effectively manage workload and deliverables.
• Excellent verbal and written communication skills.
• Thrives in a small size company and cross-functional team driven environment.
• A responsible team player that takes initiative and has a solution driven mindset.
• Experience with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).