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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in reliability engineering, risk management, and compliance with medical device regulations. Proficient in evaluating and validating Class III medical devices while collaborating with cross-functional teams to enhance product quality and patient safety.
Highest-signal resume keywords
Reliability EngineeringRisk Management21 CFR 820 ComplianceISO 13485 CertificationDesign Verification and Validation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data AnalysisRoot Cause InvestigationElectrical Design EvaluationStatistical TechniquesRisk AssessmentVerification and ValidationTechnical Report WritingProduct Performance AnalysisClinical KnowledgeTraceability and Testability
Soft Skills
CollaborationProblem-SolvingCommunication
Tools & Technologies
Reliability ToolsCRM Products
Industry Keywords
Class III Medical DevicesImplantable PacemakersDefibrillatorsISO 14971Post-Market Surveillance
About the role
Key responsibilities & impact- Support reliability and engineering activities to analyze, debug, and recommend design or process changes
- Assist with risk analysis studies of designs and processes related to product quality and patient safety
- Author or support risk assessments, technical reports, and analysis documentation
- Potentially fulfill the “Personnel with Clinical Knowledge” role in risk management assessments
- Support verification and validation of device system requirements, including traceability and testability
- Evaluate finished product systems across requirements, design, development, documentation, integration, testing, verification, and validation
- Interpret and decompose system and product requirements and verify compliance with standards and specifications
- Collaborate with cross-functional partners to investigate quality issues and support corrective actions
- Analyze product performance data and summarize findings for post-market surveillance and product improvement
- Support post-market quality activities for implantable pacemakers, defibrillators, and leads
Requirements
What you’ll need- Bachelor’s degree in Engineering, Science, or a technical discipline
- Minimum of 2 years of work experience in Engineering, Science, or a related technical field, or 0 years with an advanced degree in Electrical Engineering, Engineering, Science, or a related technical discipline
- For baccalaureate degrees earned outside the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
- Unrestricted U.S. work authorization at the time of hire and for the duration of employment
- Understanding of CRM products and their clinical use
- Experience in reliability engineering or risk management
- Experience with root cause investigations and assessing risk impact of proposed design changes
- Experience with 21 CFR 820, ISO 13485, and ISO 14971
- Ability to evaluate and debug electrical designs, including RF performance
- Experience with design, verification, and validation of Class III medical devices or similar regulated products
- Ability to perform data analysis using statistical techniques and reliability tools
- Preferred: clinical field experience utilizing CRM products
Benefits
Comp & perks- 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
- Capital Accumulation Plan for eligible employees
- Short-term incentive through the Medtronic Incentive Plan (MIP)
