Failure Analysis Engineer

Associate Failure Analysis Engineer Job Snapshot Location: Acton, MA | Onsite Pay: $53.96 - $53.96/hour Employment Type: Contract Work Type: Full-time Experience Level: Mid Level Duration: 3 months Opportunity Summary Join the quality team at a medical device manufacturer in a hands-on engineering role investigating FDA-approved devices after they reach the market. You will test products, trace failures to their root cause, and keep the records that support quality and regulatory compliance. This is a 3-month, onsite contract in Acton, MA. Responsibilities Perform product testing and failure analysis, from investigation triage through deep-dive root cause analysisTroubleshoot new failure modes and develop hypotheses for the cause of failuresReview lot acceptance records and device history records, and build trend charts from quality dataGenerate and maintain quality records, including NCRs, CAPAs, training, and internal audit documentationSupport information gathering during FDA and ISO 13485 inspections and apply Lean Six Sigma to improve process flow Qualifications Required Bachelor’s degree in an engineering or scientific discipline, or equivalent experienceStrong organization and attention to detail, with the ability to work in cross-functional teamsAbility to operate basic hand tools Preferred Electrical and mechanical background2 years in a Quality function working with QSR and/or ISO 13485Experience in a regulated industry (medical device) or a bio-hazard or lab environmentKnowledge of Six Sigma, Lean, SPC, ASQ, or ISO process controlsProficiency in MS Excel, including creating and analyzing chartsExcellent technical writing skills Why Join Us Hands-on engineering work investigating real FDA-approved medical devicesExposure to FDA and ISO 13485 inspections and quality system processesCollaborate with quality assurance engineers and cross-functional teamsOnsite role in Acton, MA Benefits: Eastridge Workforce Solutions offers the following benefits, subject to applicable eligibility requirements. Use this link https://applicantcenterstorage.blob.core.windows.net/public-documents/EWSb1cb390e-729b-47eb-ab2f-b92adafbdd07-2024EplicaBenefitSummaryTempExternal.pdf to learn more about benefits available to Eastridge’s temporary employees. Due to the varying length(s) of temporary assignments, Eastridge Workforce Solutions’ Temporary Staff are not eligible for paid time off, unless required by applicable state law in which the position is based. However, from time to time Eastridge’s clients may offer additional benefits to Eastridge employees while on assignment. Information about those benefits will be communicated when applicable. Disclaimer: The compensation and benefits information in this posting represents Eastridge’s good faith and reasonable estimate of what it might pay for this position. Eastridge reserves the right to modify this information 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. Please note that Eastridge is unable to provide visa sponsorship to applicants. Background Checks: Certain clients require Eastridge Workforce Solutions to perform background checks. Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the California Fair Chance Act, the Los Angeles City Fair Chance Ordinance, Los Angeles County Fair Chance Ordinance for Employers, and the San Francisco Fair Chance Ordinance. 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. 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