What are the responsibilities and job description for the Failure Analysis Engineer position at SPECTRAFORCE?
Job Title: Associate Failure Analysis Engineer
Location: Acton, MA (Onsite)
Duration: 3 Months
Job Description:
The Associate Failure Analysis Engineer will be part of the Quality team, focusing on post-market investigation of FDA-approved medical devices. This is a hands-on role requiring strong analytical skills, attention to detail, and collaboration with cross-functional teams to ensure product quality and compliance.
Key Responsibilities:
- Perform failure analysis and product testing
- Conduct root cause investigations and develop hypotheses
- Maintain and review quality documentation (CAPA, NCR, audits, training records)
- Analyze DHRs and Lot Acceptance data, create trend reports
- Collaborate with QA and cross-functional teams for quality compliance
- Support FDA and ISO 13485 audits/inspections
- Apply Lean Six Sigma methodologies to improve processes
- Troubleshoot new failure modes and improve product reliability
Required Qualifications:
- Bachelor’s degree in Engineering or Scientific discipline
- ~2 years of experience in Quality / Failure Analysis / Testing
- Strong Excel skills (data analysis, charts, reporting)
- Knowledge of ISO 13485, QSR, CAPA, NCR processes
- Strong analytical and documentation skills
Preferred Qualifications:
- Experience in medical devices or regulated industry
- Electrical or Mechanical background
- Knowledge of Lean, Six Sigma, SPC, ASQ
- Experience working in lab or bio-hazard environments
Equal Employment Opportunity (EEO) Statement:
We are an Equal Opportunity Employer and consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Applicant Data & Privacy Notice:
Candidate information will be used solely for recruitment purposes and handled in accordance with applicable data protection and privacy laws.
Salary : $50 - $52