Overview
Quality Engineer – Failure Analysis (Medical Device) Jobs in Acton, MA at Advantage Technical
Title: Quality Engineer – Failure Analysis (Medical Device)
Company: Advantage Technical
Location: Acton, MA
Associate Failure Analysis Engineer
Location: Acton, MA 01720
Pay: $51 an hour or about $103,000 a year
Job Type: 6 month contract with opportunity to extend
Associate Failure Analysis Engineer
The Associate Failure Analysis Engineer is a key contributor within Insulet’s Quality Department, serving in a hands-on engineering role focused on post-market investigations of FDA-approved medical devices. This position requires strong organizational skills, attention to detail, and the ability to collaborate effectively across cross-functional teams to achieve departmental and company objectives.
Key Responsibilities
- Perform moderately complex tasks to ensure compliance with quality standards and regulatory requirements
- Collaborate with Quality Assurance Engineers and cross-functional teams to implement and maintain effective inspection and testing procedures
- Generate, review, and maintain quality system records, including training documentation, internal audits, Nonconformance Reports (NCR), and Corrective and Preventive Actions (CAPA)
- Conduct product testing and perform detailed failure analysis investigations
- Review Lot Acceptance Records and Device History Records (DHRs); develop and maintain trend charts and data analyses
- Perform investigation triage and execute in-depth root cause investigations to develop failure hypotheses
- Collect, log, and analyze quality data; identify trends and drive continuous improvement
- Take ownership of quality investigations and root cause analysis activities
- Support FDA and ISO 13485 audits and inspections by gathering and presenting required documentation
- Evaluate process flows using Lean Six Sigma methodologies to improve efficiency and reduce waste
- Troubleshoot and characterize new or emerging failure modes
- Assess process and engineering controls to enhance product safety, quality, and operational efficiency
- Perform additional duties as assigned
Education & Experience
Minimum Requirements
- Bachelor’s degree in Engineering, Science, or a related technical discipline, or equivalent experience
Preferred Qualifications
- 2+ years of experience in a quality-related role within a regulated industry (medical device preferred)
- Experience working with Quality System Regulations (QSR) and/or ISO 13485 standards
- Background in electrical and/or mechanical systems
- Familiarity with laboratory or biohazard environments
Skills & Competencies
- Proficiency in Microsoft Office, especially Excel (data analysis, charting, and reporting)
- Experience creating and analyzing data trends and visualizations
- Knowledge of Lean, Six Sigma, Statistical Process Control (SPC), ASQ standards, and process control methodologies
- Strong problem-solving and root cause analysis skills
- Excellent verbal communication and technical writing abilities
- Highly organized with strong attention to detail and accuracy in documentation
Physical Requirements
- Sitting: 70% | Standing: 30%
- Frequent lifting: <5 lbs
- Occasional (<5%) pushing/pulling up to 50 lbs
- Ability to operate basic hand tools
