Senior Medical Device Sustaining Engineer

Insight Global; Irvine (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Insight Global is seeking a Staff / Senior Staff Sustaining Engineer in Irvine, CA to lead sustaining activities for a growing medical device company. You will own product quality, reliability, and lifecycle improvements, driving complex investigations and engineering changes across functions.

The ideal candidate has extensive medical device sustaining experience, strong technical judgment, and can independently steer investigations from start to resolution.

Qualifications

• 8+ years of engineering experience in medical devices, with 3–4 years in sustaining engineering for commercial devices.
• Strong hands-on experience leading investigations, including complaints, field failures, RCA, CAPAs, and corrective actions.
• Experience implementing engineering changes across components, materials, suppliers, processes, and product improvements.
• Demonstrated technical leadership and independent problem-solving, owning complex challenges and cross-functional solutions.

Responsibilities

• Lead technical investigations for product complaints and field failures.
• Drive CAPAs and corrective actions to resolve issues and prevent recurrence.
• Coordinate with Mechanical, QA, Manufacturing, Regulatory, and Supply Chain teams.
• Develop and refine sustaining processes and SOPs to support the product lifecycle.

Skills

Sustaining engineering

Root-cause analysis

CAPA management

Cross-functional leadership

Mechanical engineering

Regulatory knowledge

Education

Bachelor’s degree in Mechanical Engineering or related

Job description

Insight Global is seeking a Staff / Senior Staff Sustaining Engineer in Irvine, CA to lead sustaining activities for a growing medical device company. You will own product quality, reliability, and lifecycle improvements, driving complex investigations and engineering changes across functions.

The ideal candidate has extensive medical device sustaining experience, strong technical judgment, and can independently steer investigations from start to resolution.