Associate Failure Analysis Engineer (On-site, Acton, MA.)

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

Responsibilities:

• 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 hypothesis for failure.
• Collect log quality data and trend results.
• 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.
• Trouble shoot new failure modes.
• Evaluate process and engineering controls to improve safety and efficiency.
• Perform other duties as assigned.

Minimum Requirements:

• Bachelor’s Degree or a minimum of 3 years experience in an engineering or technical role.

Preferred Skills and Competencies:

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

Physical Requirements (if applicable):        

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

Additional Information:

The US base salary range for this full-time position is $31.00 - $46.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.