Quality Engineer

Description

This role will be responsible for ensuring the new catheter and console products and design changes to existing products meet regulatory and quality requirements throughout the design, development, and manufacturing transfer process. This will be accomplished through close collaboration with cross‑functional teams. The Quality Engineer participates in all phases of the product development process. This includes development, reliability testing, design controls, input requirements, early design feasibility testing and verification and validation, manufacturing process development activities, product risk management requirements, and delivery.

This role is structured as a temporary contract engagement with the potential to transition to a permanent position based on performance and business needs.

• Has a focus on the sustaining engineering aspects of sterile disposable design quality assurance, and electrical hardware product design quality assurance
• Coordinate and perform device complaint investigations, including product decontamination and product evaluation activities
• Supports complaint trending and analysis
• Provide support for on‑site manufacturing operations, including disposable and console manufacturing quality inspections and lot release, and equipment qualification and maintenance
• Review requirements, specifications, and technical design documents to provide timely feedback
• Draft and review design control deliverables for catheter and console development or design/process changes
• Actively participate in risk analysis development and maintenance including FMEAs, hazard analysis, and other risk management file requirements
• Responsible for the review and approval of design and process verification and validation protocols and test reports
• Support Process/Design Validation/Verification activities including process validation, IQ/OQ/PQ activities.
• Lead and support root cause investigations and actions for issues arising from design or process verification and validation activities
• Responsible for evaluating proposed component, supplier, and process changes for potential impact to sterility, biocompatibility, functionality, integrity and shelf life
• Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products. Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
• Provide quality and compliance support during regulatory audits and responses to government agency questions
• Lead as Quality Engineering support for non‑conforming material investigations and associated CAPAs
• Lead and assist CAPA efforts, and apply systematic root cause problem‑solving methodologies identifying, prioritizing, communicating, and driving resolution of quality issues
• Perform quality driven statistical analysis
• Other duties as assigned

• Minimum of 5 years’ experience in engineering and development of sterile disposable devices or electro‑mechanical devices
• A bachelor’s degree in science, engineering, or other related technical discipline or equivalent work experience
• Experience in medical device design assurance
• Experience in design verification and transfer to manufacturing activities
• Understanding of medical device design controls and risk management regulations such as ISO 13485, FDA QMSR, MDR (EU) 2017/745, ISO 14971, 60601, 62366, 62304, and other relevant product standards
• Knowledge of US and International regulations, such as 21 CFR Parts 820, 210, 211, and 11 and other relevant regulations
• 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

• Degree in biomechanical engineering preferred
• Experience in medical imaging
• ASQ Certified Quality Engineer (CQE)
• Six Sigma Green or Black Belt
• Experience Minitab Statistical Analysis software (or equivalent)
• Experience with microbiology considerations in manufacturing and product design validation