Sr Electrical Engineer
Planet Pharma · Lafayette, CO · 2 wk ago
EngineeringContract
Primary Responsibilities
- Contribute to the maintenance and testing of mixed-signal electrical systems and circuits for medical devices, ensuring compliance with applicable regulatory standards (e.g., IEC 60601).
- Develop detailed specifications, schematics, and PCB layouts, collaborating closely with cross-functional teams to meet design and performance requirements.
- Ensure reliability, develop technical specifications for test hardware conformance to specifications; may include modifying existing products.
- Contributes to technical project planning, establish timelines, define deliverables, and proactively identify and mitigate potential risks.
- Develop detailed specifications for replacement of obsolete components; may include development of test specifications, regulatory assessment, and standards testing (e.g., IEC 60601).
- Monitor, investigate, and validate customer complaint trends to determine if product needs additional modifications or redesign while maintaining product requirements.
Requirements
- Mixed Signal Electrical System Design & Analysis
- Proven expertise across end to end mixed signal board design: system architecture, circuit design, schematic capture, component selection, PCB layout, and design verification
- Strong fundamentals in signal integrity, frequency domain analysis, and circuit theory
- Ability to design, test, and integrate medium?voltage and safety critical systems for medical devices
- Medical Device Regulatory Compliance & Safety Standards (IEC 60601)
- Hands?on experience designing and testing regulated medical equipment
- Strong working knowledge of IEC 60601?1 safety standard, regulatory assessments, and standards?based verification testing
- Experience handling component obsolescence, regulatory impact assessments, and compliance testing
- Hardware Verification, Debugging & Reliability Engineering
- Extensive use of lab test equipment (oscilloscopes, logic/network analyzers, DMMs) for system integration, debugging, and validation
- Experience developing test specifications, validating conformance, and ensuring long?term reliability
- Experience analyzing customer complaints, identifying root causes, and driving design improvements without compromising requirements