PCB Design/Layout Engineer

Key Responsibilities

• Design, develop, maintain, and test mixed-signal electrical systems and circuitry for regulated medical devices.
• Develop system architecture, schematic designs, component specifications, and PCB layouts.
• Participate in all phases of electrical design including requirements development, architecture, circuit design, verification, and validation.
• Support integration of medium-voltage and safety-critical electrical systems.
• Create detailed technical specifications, design documentation, and engineering reports.

Verification, Testing & Reliability

• Develop and execute hardware verification and validation plans.
• Create test specifications and ensure product conformance to performance and regulatory requirements.
• Utilize laboratory equipment such as oscilloscopes, multimeters, logic analyzers, and network analyzers for debugging, integration, and testing.
• Investigate product performance issues and implement corrective actions to improve reliability.
• Support design changes and enhancements while maintaining compliance and product requirements.

Regulatory Compliance & Risk Management

• Ensure designs comply with applicable industry standards and regulatory requirements, including IEC 60601-1.
• Support standards-based testing, regulatory assessments, and compliance documentation.
• Absess the impact of component obsolescence and implement compliant replacement solutions.
• Participate in risk assessments and design reviews related to product safety and performance.

Sustaining Engineering & Product Lifecycle Support

• Monitor and evaluate customer complaint trends and field performance data.
• Conduct root cause investigations and develop effective engineering solutions.
• Support continuous improvement initiatives and lifecycle management activities.
• Contribute to technical project planning, risk mitigation, and execution of engineering deliverables.

Leadership & Collaboration

• Serve as a technical resource and mentor to junior engineers and team members.
• Work effectively within cross-functional teams including software, mechanical, quality, manufacturing, and regulatory functions.
• Support project execution from concept through commercialization.
• Contribute technical expertise to design reviews, problem-solving efforts, and strategic engineering initiatives.