Systems Engineer
Roles & Responsibilities
- Conduct root cause analysis and implement corrective actions for product issues.
- Develop and execute test plans for verification, validation, and compliance.
- Evaluate risks associated with product changes and propose mitigation strategies.
- Work with cross-functional teams (engineering, operations, quality, regulatory) to implement product updates.
- Ensure design for manufacturability, testability, and reliability by collaborating with suppliers.
- Maintain thorough documentation of design changes, testing results, and risk assessments.
Experience Required
- Minimum 5 years in medical device engineering or related field.
- Strong understanding of regulatory compliance and risk management.
- Hands-on experience with troubleshooting electromechanical devices.
- Background in Systems Engineering and structured problem-solving methodologies.
- Proficiency in statistical testing methods and failure mode analysis (FMEA).
Skills & Certifications
- Root cause analysis, risk management, and regulatory compliance.
- PCB and PCBA design knowledge.
- Hands-on experience with laboratory tools.
- Proficiency in engineering software for design and analysis.
- Strong communication and collaboration skills.
Eligibilities & qualifications
- Bachelor’s, Master’s, or PhD in Electrical Engineering or related field.
- Minimum 5 years of relevant experience.
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