Senior Principal Quality Engineer
Medtronic
full-time
Posted on:
Location Type: Office
Location: Minneapolis • Colorado • Connecticut • United States
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Salary
💰 $147,200 - $220,800 per year
Job Level
About the role
- Lead risk management strategy for medical device products (Capital and disposable)
- Develop and maintain comprehensive strategies for risk management activities
- Perform thorough hazard analyses to identify potential risks and implement effective mitigation measures
- Lead Failure Modes and Effects Analyses (FMEAs)
- Analyze and review product complaints to anticipate and prevent future issues
- Conduct detailed risk analyses in conjunction with the system engineering team
- Implement and maintain robust product security measures
- Develop and manage post-market surveillance plans
- Maintain and curate risk logs
- Collaborate with cross-functional teams to implement systems engineering processes
Requirements
- Bachelor’s degree in Engineering, or a related technical field
- In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards
- Strong analytical and problem-solving skills
- Excellent written and verbal communication skills
- Proven leadership and project management skills
- Certifications: Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent preferred
- Experience in Quality Assurance, Engineering, Capital equipment Industry Experience in Medical device industry.
- Proficient in quality assurance practices, risk management, and regulatory compliance
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement
- Capital Accumulation Plan
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
risk managementhazard analysisFailure Modes and Effects Analysis (FMEA)post-market surveillancequality assurance practicesregulatory complianceproduct security measuressystems engineering processes
Soft skills
analytical skillsproblem-solving skillswritten communicationverbal communicationleadership skillsproject management skills
Certifications
Certified Quality Engineer (CQE)Six Sigma Green Belt