Senior Principal Quality Engineer
Medtronic
full-time
Posted on:
Location Type: Hybrid
Location: Minneapolis • United States
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Salary
💰 $147,200 - $220,800 per year
Job Level
About the role
- Lead risk management strategy for our medical device products
- Create and manage risk management plans and reports, as well as conduct regular risk reviews
- Perform thorough hazard analyses to identify potential risks and implement effective mitigation measures
- Lead Failure Modes and Effects Analyses (FMEAs) in collaboration with project teams
- 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 to monitor product performance and safety
- Maintain and curate risk logs
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 with the ability to conduct thorough root cause analysis
- Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders
- Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously
- Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification is preferred
- Experience in Quality Assurance, Engineering, Capital equipment Industry Experience: 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
- Simple Steps (global well-being program)
- 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 (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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)root cause analysispost-market surveillancequality assurance practicesregulatory complianceproduct security measuresanalytical skillsproblem-solving
Soft skills
leadershipproject managementcommunication skillscollaborationanalytical thinkingpresentation skillsteam managementorganizational skillsinterpersonal skillsmulti-project management
Certifications
Certified Quality Engineer (CQE)Six Sigma Green Belt