Managing an IEC 60601-1 testing project, serving as main point of contact with test laboratory, triaging issues to core team members, troubleshooting test issues, documenting of test plan, test report
Performing standards-based testing, specifically EMC and safety testing
Supporting different divisions for sustaining fielded products
Analyzing design changes from individual circuits up to fully configured products
Component analysis for BOM replacements, specifying needed testing to support a BOM replacement
Testing new or replacement circuit board level components, assessing results against test criteria
Assessing electrical and system compatibility between medical devices
Working with internal manufacturing or contract manufacturing on manufacturing associated challenges
Analyzing challenges or failures of circuit boards, cables, power supplies, or displays.
Electrical testing of PCBAs and products, documenting and implementing design updates
Working cross-functionally with quality, regulatory, sourcing, and manufacturing departments
Support regulatory submissions by answering questions about test results, rationale for design requirements, or standards compliance
Ensure compliance with internal Quality System requirements across all engineering documentation
Education/Experience:
Bachelor’s degree or higher in systems or electrical engineering from an accredited institution.
Minimum of 7 years' experience in electrical engineering, particularly in electrical hardware design and test execution
Experienced with test equipment such as multimeters, oscilloscopes, signal generators, spectrum analyzers, network analyzers, as well as manual tools such as soldering irons and crimpers.
Preferred:
Background in a regulated industry, preferably with Class II or III medical devices.
Strong familiarity and experience with IEC 60601-1 and IEC 60601-1-2, background in testing
Ability to work cross-functionally across engineering, quality, regulatory, and manufacturing.
Experience with Altium PCB layout tool.
Numbers & Facts
Location
Saint Paul, MN
Skills
Analysis Skillsunmatched
Bill of Materials (BOM)unmatched
Circuit Componentsunmatched
Contract Manufacturingunmatched
Cross-Functionalunmatched
Documentationunmatched
Electrical Designunmatched
Electrical Engineeringunmatched
Electricityunmatched
Failure Analysisunmatched
Hardware Designunmatched
Hardware Quality Assuranceunmatched
International Electro-Technical Commission (IEC)unmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Requirementsunmatched
Medical Equipmentunmatched
Network Performance/Analysisunmatched
Oscilloscopeunmatched
Printed Circuit Board (PCB)unmatched
Printed Circuit Board (PCB) Layoutunmatched
Printed Circuit Board Assembly (PCBA)unmatched
Problem Solving Skillsunmatched
Product Documentationunmatched
Quality System Requirements (QSR)unmatched
Regulationsunmatched
Regulatory Complianceunmatched
Regulatory Submissionsunmatched
Requirements Managementunmatched
Solderingunmatched
Spectrum Analyzersunmatched
Systems Analysisunmatched
Systems Engineeringunmatched
Test Designunmatched
Test Equipmentunmatched
Test Labunmatched
Test Plan/Scheduleunmatched
Testingunmatched
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