Senior Failure Analysis Technician

About the role

Seeking an experienced Senior Failure Analysis Technician to support product investigations within a medical device manufacturing environment. This role will lead failure analysis activities involving customer complaints, returned products, and manufacturing nonconformances while supporting root cause investigations, CAPA activities, and continuous improvement initiatives. The ideal candidate will have strong experience with endovascular medical devices, complaint investigations, and regulated quality systems.

Essential Duties and Responsibilities

• Lead failure investigations involving returned products, customer complaints, and manufacturing issues
• Perform visual inspections, functional testing, dimensional evaluations, and product analysis to identify failure modes
• Review Device History Records (DHRs), manufacturing documentation, inspection data, and test results
• Conduct root cause analysis using tools such as 5 Whys, Fishbone, and Fault Tree Analysis
• Prepare technical investigation reports and documentation for quality and regulatory review
• Support CAPA activities and collaborate with Engineering, Manufacturing, Quality, and Regulatory teams
• Identify failure trends and recommend process improvements
• Provide technical guidance and mentorship to junior technicians

Qualifications

• 7+ years of experience in failure analysis, complaint handling, root cause analysis, or quality assurance within a regulated medical device environment
• 5+ years of experience supporting Class II and/or Class III medical devices, preferably endovascular products
• Experience investigating returned products, field failures, and manufacturing nonconformances
• Knowledge of FDA Quality System Regulations, ISO 13485, CAPA, and complaint handling processes
• Experience reviewing Device History Records (DHRs) and technical documentation
• Strong technical writing, problem-solving, and communication skills

Benefits

• Medical, vision, dental
• 401k
• Sick time, holiday, and vacation pay

Disclaimer

The compensation and benefits information in this posting represent a good faith and reasonable estimate of what it might pay for this position. This information may be modified at any time, subject to applicable law. Equal Opportunity Employer: Eastridge Workforce Solutions is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity, and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, gender expression, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Eastridge Workforce Solutions also prohibits harassment or retaliation of applicants or employees based on any of these protected categories. It is our policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Massachusetts Candidates: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Privacy: Information collected and processed as part of your candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Eastridge’s Privacy Policy https://www.eastridge.com/privacy-policy, as well as Eastridge’s Pre-Use Notice of Collection and Automated Decision-Making Technologies https://www.eastridge.com/data-collection-notice. By applying for this job, you agree to receive calls, AI-generated calls, if applicable, text messages, or emails from Eastridge Workforce Solution, and/or its agents and contracted partners related to confirming assignments and job openings. Message frequency may vary. Standard message and data rates may apply depending on your mobile carrier. To opt out of receiving SMS messages from us at any time, simply reply to the text with “STOP.” Please be aware that message and data rates may apply to any SMS messages sent or received. You can access our SMS Terms and Conditions by visiting https://www.eastridge.com/sms-terms-and-conditions