Senior Design Quality Engineer – Medical Devices
Cardinal Health
full-time
Posted on:
Location Type: Hybrid
Location: Mansfield • Massachusetts • Montana • United States
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Salary
💰 $68,500 - $97,800 per year
Job Level
About the role
- 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
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
- Travel Expectations: 10%
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 improvementdesign verificationdesign validationdesign transfer
Soft Skills
attention to detailorganizational skillsproblem-solvingtechnical writingcommunicationcollaboration
Certifications
Bachelor’s degree in engineering