Associate Failure Analysis Engineer

Associate Failure Analysis Engineer

Position:
Associate Failure Analysis Engineer

Location:

Acton, MA

Project Duration: 3 months

Rate:
Negotiable Based on Experience

Role Overview

The Associate Failure Analysis Engineer plays an integral role in the Quality Department as a hands-on engineering role conducting post-market investigations of FDA-approved medical devices. The position requires organization skills, attention to detail, the ability to work in cross-functional teams, and a drive to accomplish departmental and company goals.

• Perform moderately complex tasks to ensure compliance with quality standards.
• Partner with quality assurance engineers and other team members to ensure effective inspection and testing procedures are implemented and maintained.
• Generate, review and maintain Quality records in support of the Quality System, e.g., training, internal audits, NCR, and CAPA.
• Perform product testing and failure analysis.
• Review Lot Acceptance records and DHRs, create trend charts.
• Perform investigation triage and deep dive investigations to develop a hypothesis for failure.
• Collect and log quality data and trend results.
• Provide accountability for quality investigation and root cause analysis.
• Assist in gathering information during FDA and ISO 13485 inspections.
• Evaluate process flow by applying Lean Six Sigma methodology to streamline.
• Troubleshoot new failure modes.
• Evaluate process and engineering controls to improve safety and efficiency.
• Perform other duties as assigned.

Education:

Bachelor's Degree in an engineering or scientific discipline, or equivalent experience.

• Computer proficiency in MS office (specifically Excel).
• Electrical and mechanical background is preferred.
• Experience creating and analyzing charts in MS Excel is a plus.
• Knowledge of Six Sigma, Lean, SPC, ASQ and/or ISO process controls is a plus.
• Prior experience working in a regulated industry (medical device) and/or experience working in a bio-hazard/lab environment is preferred.
• Preferred 2 years in a Quality-related function, working with QSR and/or ISO 13485.
• Effective verbal and technical writing skills.
• Excels at generating and maintaining organized and accurate records.

• Sitting 70%, Standing 30%
• Frequent lifting under 5lbs
• Occasional (less than 5% of time) handling (push/pull) up to 50lbs
• Ability to operate basic hand tools

The pay range for this position is between $45.00 and $51.00 per hour. Please note that the pay range provided is a good faith estimate for the position at the time of posting. Final compensation may vary based on factors including but not limited to background, knowledge, skills, and experience. Apex Systems offers a benefits package that includes medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan.

Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid sick leave and other paid time off may vary by client location and applicable state law.

This employer is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.