Job Summary
Job Title: Associate Failure Analysis Engineer
Department: 8610 – QA Post Market Quality Assurance
FLSA Status: Non-Exempt
Position Overview:
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.
Education and Experience:
Minimum Requirements:
HBO or Bachelor’s Degree in an engineering or scientific discipline , or equivalent experience (BioMedical Engineering, Industrial Engineering, Mechanical Engineering, Electronics Engineering, Manufacturing Engineering).
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/2.3kgs
Occasional (<5% of time) handling (push/pull) up to 50lbs/23kgs
Ability to operate basic hand tools
Job Title: Associate Failure Analysis Engineer
Department: 8610 – QA Post Market Quality Assurance
FLSA Status: Non-Exempt
Position Overview:
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.
Education and Experience:
Minimum Requirements:
- Bachelor’s Degree in an engineering or scientific discipline , or equivalent experience.
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
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.
We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
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