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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing and maintaining risk management strategies, ensuring compliance with FDA and ISO standards, and leading design validation and verification activities. Proficient in risk analysis, product quality assurance, and cross-functional collaboration to enhance patient safety.
Highest-signal resume keywords
Risk Management StrategiesDesign Failure Modes and Effects Analysis (DFMEA)FDA ComplianceISO 14971Statistical Analysis Software (Minitab)
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Risk AnalysisRoot Cause AnalysisPost-Market SurveillanceDesign ValidationDesign Control
Soft Skills
Strong Communication Skills
Tools & Technologies
Microsoft Office (Excel, Word, PowerPoint)Requirements Management Tool
Certifications & Qualifications
Certified Quality EngineerSix Sigma Green BeltAAMI Design Control Certification
Industry Keywords
Medical DevicesPharmaceuticalsQuality EngineeringRisk ManagementNew Product Development
About the role
Key responsibilities & impact- Develop and maintain comprehensive risk management strategies
- Collaborate cross-functionally to ensure product quality and patient safety
- Create and maintain risk management files, plans, and reports
- Conduct regular risk reviews
- Lead hazard and risk analysis activities and implement risk controls
- Lead Design Failure Modes and Effects Analyses (DFMEAs)
- Analyze and review product complaints to anticipate and prevent future issues
- Integrate product security measures and vulnerabilities into the risk management file
- Participate in Process FMEA/User FMEA development and integrate results into the risk management file
- Lead design reviews and maintain the risk management file throughout the product lifecycle
- Develop and manage post-market surveillance plans
- Lead field issue evaluations, including root cause analysis, risk evaluation, and product containment strategy, during initial launch
- Ensure traceability among the risk management file, requirements, and design outputs using a requirements management tool
- Evaluate safety risk implications of design changes
- Define and implement engineering and statistical processes supporting product quality and compliance
- Ensure compliance with FDA, ISO 14971, ISO 13485, IEC 62304, FDA Part 820, and other international standards
- Participate in regulatory audits and inspections
- Oversee design validation and verification activities, including test plans, protocols, methods, and reports
- Ensure accurate documentation of test results, risk assessments, and reports
Requirements
What you’ll need- Bachelor's degree in engineering or a related technical field
- Unrestricted U.S. work authorization at the time of hire and for the duration of employment
- Experience in medical devices, pharmaceuticals, or combination products preferred
- Familiarity with medical device risk management standards, including ISO 14971 concepts, preferred
- Prior involvement in New Product Development environments preferred
- Background in Quality Engineering, Risk Management, R&D, Systems Engineering, or similar roles preferred
- Clinical knowledge or experience supporting clinical risk assessment preferred
- Experience using Minitab or other statistical analysis software preferred
- Certification or experience with Design for Six Sigma / Design for Reliability methodologies preferred
- Strong written, verbal, and digital communication skills preferred
- Proficiency with Microsoft Office tools, including Excel, Word, and PowerPoint, preferred
- Certified Quality Engineer, Six Sigma Green Belt, or equivalent certification preferred
- AAMI design control certification preferred
- For baccalaureate degrees earned outside the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
Benefits
Comp & perks- Competitive benefits package
- Short-term incentive through the Medtronic Incentive Plan (MIP)
- Health insurance
- Dental insurance
- 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
- Capital Accumulation Plan for eligible employees
- Paid sick time for temporary employees as required by state law
- Equal employment opportunity and reasonable accommodations for qualified individuals with disabilities