Senior Staff Sustaining Engineer

Required Skills & Experience

• 8+ years of engineering experience within the medical device industry, including at least 3-4 years of hands-on sustaining engineering experience supporting commercial medical devices.
• Strong hands-on experience leading technical investigations, including product complaints, field failures, root-cause analysis, CAPAs, and corrective actions.
• Experience implementing engineering changes involving product components, materials, suppliers, manufacturing processes, and product improvements.
• Demonstrated technical leadership and independent problem-solving, including ownership of complex engineering challenges and driving cross-functional solutions.
• Bachelor’s degree in Mechanical Engineering or a related engineering discipline, including Biomedical, Materials, Chemical, or Manufacturing Engineering.
• Knowledge of medical device regulations and quality systems, including FDA requirements, ISO 13485, and verification and validation processes.

Nice to Have Skills & Experience

• Previous mechanical design engineering or process development experience prior to transitioning into sustaining engineering.
• Experience with disposable or single-use medical devices, including polymers, adhesives, injection molding, or sterile packaging.
• Experience with specialized testing and validation, including biocompatibility, sterility assurance, sterile barrier testing, or process validation.
• Experience in smaller medical device companies or startups, including developing sustaining processes, SOPs, or complaint-handling infrastructure.

Job Description

Insight Global is seeking a Staff / Senior Staff Sustaining Engineer to join an innovative, growing medical device company in Irvine, CA. This is an opportunity to take on a key technical leadership role within a growing engineering organization, helping establish and advance sustaining engineering capabilities for a new medical device product.

This individual will have significant ownership over product quality, reliability, and performance throughout the commercial lifecycle, leading complex technical investigations, resolving field and manufacturing issues, and driving engineering changes and product improvements. Working closely with Mechanical Engineering, Quality, Manufacturing, Regulatory, and Supply Chain teams, this engineer will play an integral role in shaping sustaining processes and ensuring long-term product success.

The ideal candidate brings extensive medical device sustaining experience, strong technical judgment, and the ability to independently drive complex engineering challenges from investigation through resolution.