Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.
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!
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
NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite
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Top Skills
What We Do
Insulet Corporation, 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 disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. 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. Founded in 2000 (NASDAQ: PODD), Insulet operates with a customer-centric focus to supply high-quality products and expand the use of insulin pump therapy. Omnipod products are now available in 20+ countries around the globe.
HIRING SCAM ALERT
Recently, individuals impersonating Insulet Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists, please be aware that:
• Insulet will never interview a candidate over RingCentral, similar messaging apps or social media (i.e. Google Hangouts, WhatsApp, Facebook Messenger, etc.), or via text message.
• Insulet will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment.
• Insulet will never provide excess money to an applicant and ask the applicant to write a check for repayment.
If you have any doubt about a job offer or any other communication purporting to come from Insulet, please reach out to us directly at 978-600-7000.
If you receive any type of communication on behalf of Insulet that seems inappropriate or suspicious, please report this activity to: www.iC3.gov or www.stopfraud.gov
