Sr Design Quality Engineer – Medical Devices

Cardinal Health • El Paso, TX

1d

About The Position

Design Quality Engineering drives quality excellence throughout the design and development life cycle of medical devices. This function ensures robust design control processes including risk management, design planning, design verification, design validation, and preparation for design transfer. Design Quality Engineering collaborates with cross- functional teams contributing to resolution of quality issues, development and adherence to quality policies, procedures, and processes to ensure compliance with regulatory standards, and achievement of long-term quality strategies.

Requirements

• Bachelor’s degree in engineering or related field preferred
• 2+ years of experience preferred
• Knowledge of medical device design and development, risk management processes, statistical analysis tools, root cause analysis, and continuous improvement.
• Understanding of industry standards, guidelines, and regulations (i.e. AAMI & ANSI standards, GMP, 21CFR820, ISO14971, IEC62366, ISO 13485)
• Strong attention to details, organizational, problem-solving, and technical writing skills.
• Confident communicator and ability to collaborate cross-functionally

Nice To Haves

• ASQ CQE

Responsibilities

• Participate in creation, review and approval of medical device design and development files including design planning, design inputs & outputs, design verification & validation, and design transfer plans.
• Develop and maintain risk management files throughout the product lifecycle, across a broad set of technologies with clear and thorough identification of hazards, hazardous situations, risk estimation and analysis, and mitigation activities to ensure continued acceptability of products.
• Work closely with Research and Development, Regulatory, Medical Affairs and Quality Operations teams to ensure timely identification, documentation, and resolution of design-related quality issues.
• Work on projects of moderate scope and complexity, identify opportunities for continuous improvement, and lead activities to implement improvements with general guidance.
• Support all company initiatives identified by leadership and be accountable for on-time completion of training, tasks, projects, and quality plans.

Benefits

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees