Hardware Engineer 2
$91,400–$152,300 year
On-siteSan Diego, California, United States or Mesa, Arizona, United States
Job Summary
Investigate postmarket issues and drive continuous improvement of complaint investigation processes, ensuring alignment with software risk management activities like hazard analysis and DFMEA. Develop deep understanding of the hardware ecosystem to evaluate product performance, identify anomalies, and lead engineering studies using statistical analysis and industry-standard tools. Collaborate with cross-functional partners including Regulatory Affairs, Quality Assurance, and R&D to resolve software- and device-related issues, perform hardware-focused risk assessments, and contribute to CAPA and Health Hazard Evaluations. Analyze and communicate investigation outcomes to stakeholders, translating postmarket insights into actionable improvements for product safety and reliability.
Required Qualifications
- demonstrated knowledge of medical device quality systems and regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, and other applicable global regulations
- strong understanding of postmarket surveillance, complaint handling, CAPA, and vigilance reporting requirements
- experience supporting hardware quality and reliability activities throughout the product lifecycle, including design and development, verification and validation, field performance monitoring, and postmarket surveillance
- strong understanding of hardware risk management principles and methodologies, with the ability to evaluate and mitigate product risks, assess field safety signals, and apply risk-based decision-making in alignment with regulatory expectations and industry best practices
- excellent communication and collaboration skills, with the ability to effectively convey complex technical concepts to both technical and non-technical stakeholders across the organization
- working knowledge of hardware engineering principles and technologies, including electromechanical systems, electronics, sensors, materials, reliability engineering, manufacturing processes, and failure analysis techniques used in medical device development and support
- proven ability to apply engineering fundamentals and structured problem-solving techniques to investigate complex issues, determine root causes, and drive effective corrective actions
- strong analytical mindset with experience interpreting data, identifying trends, and translating findings into actionable recommendations
- ability to balance technical depth with business impact, driving decisions that support product quality, patient safety, compliance, and customer experience
- experience performing postmarket surveillance activities, including complaint investigations, trending and signal detection, reliability analysis, risk assessments, CAPA support, periodic product reviews, and communication of field performance insights to internal and external stakeholders
- Bachelor's degree in a technical discipline
- minimum of 2 - 5 years related experience
- Master's degree and 0-2 years' equivalent experience
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