Senior R&D Sustainment Engineer - Medical Devices (On-Site Irvine)

Hydrogen Group; Irvine (CA); On-site; USD 71,000 - 78,000; Part time

Job summary

Hydrogen Group represents a medical device client in Irvine seeking a Senior Engineer, R&D Sustainment for 6-month contract. Responsibilities include investigating field issues, leading design changes, and ensuring regulatory compliance for Class III devices.

The role partners with Quality, Manufacturing, Regulatory, and other teams to sustain device safety, performance, and reliability through lifecycle management, V&V activities, and robust documentation.

Qualifications

• Bachelor's or higher in Engineering/Science with 4+ years' experience (or MSc with 3+ years, or PhD).
• Experience in supporting on-market medical devices, preferably Class III implantable or electromechanical devices.
• Experience with ISO 13485, ISO 14971, FDA QMS expectations and regulatory requirements.

Responsibilities

• Lead investigations into device field issues with data analysis and failure reports.
• Partner with R&D and Manufacturing to drive design changes and process improvements.
• Monitor device performance and quality metrics; address deviations.
• Lead design and process changes for on-market devices, including change control and risk assessments.
• Update FMEAs, hazard analyses, and risk management files; evaluate new hazards or risk controls.
• Develop and execute test plans, protocols, and reports to support changes and regulatory responses.

Skills

Root cause investigation

Design changes

Failure analysis

Cross-functional collaboration

Statistical methods

Documentation

Problem solving

Team work

Education

Bachelor's in Engineering/Science

Master's in Engineering/Science

PhD in Engineering/Science

Tools

Python

Minitab

Excel

CAD

Job description

Hydrogen Group represents a medical device client in Irvine seeking a Senior Engineer, R&D Sustainment for 6-month contract. Responsibilities include investigating field issues, leading design changes, and ensuring regulatory compliance for Class III devices.

The role partners with Quality, Manufacturing, Regulatory, and other teams to sustain device safety, performance, and reliability through lifecycle management, V&V activities, and robust documentation.