Job Description

Role Summary

This role will ensure design changes for new catheter and console products and 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 which 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.

Essential Responsibilities

• Has a focus on sterile disposable product design, and electrical hardware product design
• Participate in the design control and review processes, including project planning, quality planning, and phase reviews
• 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 including FMEAs, hazard analysis, and other risk management file requirements
• Responsible for the review and approval of design and 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, 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 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

Experience & Qualifications

Must have

• 3-5 years’ experience in engineering and development of sterile disposable devices and 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 21 CFR 820.30, 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.
• Ability to thrive in a small size company and cross-functional team driven environment.
• A responsible team player that takes initiative and has a solution driven mindset.

Preferred

• 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

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