Cardinal Health

Senior Design Quality Engineer – Medical Devices

Cardinal Health

full-time

Posted on:

Location Type: Office

Location: Massachusetts • Montana • United States

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Salary

💰 $68,500 - $97,800 per year

Job Level

Senior

About the role

  • Participate in creation, review and approval of medical device design and development files
  • Develop and maintain risk management files throughout the product lifecycle
  • Work closely with Research and Development, Regulatory, Medical Affairs and Quality Operations teams
  • Identify opportunities for continuous improvement, and lead activities to implement improvements
  • Support all company initiatives identified by leadership and be accountable for on-time completion of training, tasks, projects, and quality plans

Requirements

  • Bachelor’s degree in engineering or related field preferred
  • Preferred Certifications: ASQ CQE
  • 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
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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
medical device designrisk managementstatistical analysisroot cause analysiscontinuous improvementtechnical writing
Soft Skills
attention to detailorganizational skillsproblem-solvingcommunicationcollaboration
Certifications
ASQ CQE