Senior Staff 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

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.

Skills and Requirements

• 8+ years of engineering experience within the medical device industry, including at least 3-4 years of hand-on sustaining engineering experience supporting commercial medical devices.
• Strong hand-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.
• 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.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [e-mail].