Senior R&D Sustaining Engineer – Medical Devices

Ultimate Staffing; Irvine (CA); On-site; USD 69,000 - 78,000; Full time

Job summary

Ultimate Staffing seeks a Senior Engineer, R&D Sustainment in Irvine, CA to support lifecycle management of on-market Class III devices. You will work with Quality and Manufacturing to implement design and process improvements, ensure safety and regulatory compliance, and drive reliable device performance.

The role emphasizes hands-on problem solving, cross-functional collaboration, and rigorous documentation in a regulated environment. On-site at the Irvine campus with a 6-month contract.

Qualifications

• Required: Engineering/Science degree with 4 years of experience or higher degrees with corresponding experience.
• Experience with ISO 13485, ISO 14971, FDA QMS and medical device regulatory expectations.
• Experience drafting/verifying test protocols, methods, and reports.

Responsibilities

• Lead investigations of field issues and perform root-cause analysis.
• Collaborate across R&D and manufacturing to implement design and process changes.
• Monitor device performance and address deviations with corrective actions.
• Lead design and process changes for on-market devices and manage change control.
• Guide risk management activities including updates to FMEAs and hazard analyses.

Skills

Strong problem-solving

Attention to detail

Cross-functional collaboration

Education

Bachelor's Degree in Engineering or Scientific field

Master's Degree or PhD in Engineering or Scientific field

Tools

Python

Minitab

Excel

Job description

Ultimate Staffing seeks a Senior Engineer, R&D Sustainment in Irvine, CA to support lifecycle management of on-market Class III devices. You will work with Quality and Manufacturing to implement design and process improvements, ensure safety and regulatory compliance, and drive reliable device performance.

The role emphasizes hands-on problem solving, cross-functional collaboration, and rigorous documentation in a regulated environment. On-site at the Irvine campus with a 6-month contract.