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!
Review Device History Records (DHR) for medical device products in the Post LQ laboratory, ensuring all production, inspection, and release records are complete and compliant with ISO 13485 and company quality system requirements.
Lead product Failure Analysis (FA): collect failed samples, develop analysis plans, conduct testing and data analysis, and generate FA reports to drive root cause closure and continuous improvement.
Oversee batch product functional testing, visual inspection, and performance verification; promptly identify and address anomalies, and drive implementation of Corrective and Preventive Actions (CAPA).
Support laboratory equipment management, including calibration, maintenance, and verification, ensuring accuracy and reliability of test data.
Participate in customer complaint handling, returns, and nonconformance management, including data collection, root cause analysis, and corrective action planning.
Engage in supplier audits, incoming material and finished product inspections, ensuring supply chain quality stability.
Collect and analyze quality data, regularly generate quality reports, and support laboratory performance improvement.
Organize or participate in quality training for staff to enhance team quality awareness and operational skills.
Communicate effectively with cross-functional teams and global stakeholders in both Chinese and English.
Bachelor’s degree or above in Mechanical Engineering, Materials Science, Biomedical Engineering, Quality Management, or related fields.
Minimum 2 years of quality engineering or management experience in the medical device or related industry, with solid knowledge of ISO 13485 and GMP regulations.
Proficient in DHR review processes and failure analysis methodologies, with strong problem-solving skills.
Skilled in quality tools (FMEA, SPC, 8D, QC tools) and capable of independently preparing analysis reports.
Familiar with common measurement instruments and laboratory operations.
Strong communication and teamwork skills; able to work under pressure.
Advanced data analysis skills; proficient in Excel, Minitab, or similar tools.
Experience with medical device registration, quality system audits, or supplier management is a plus.
Continuous improvement mindset and ability to proactively drive quality projects.
Excellent English reading, writing, and speaking skills are mandatory. Ability to read and draft technical documents and communicate with global teams in English is required.
Experience in CAPA management, risk assessment, and validation/verification projects.
ISO 13485 internal auditor certification or relevant training.
Experience in an international or cross-cultural work environment.
Skills Required
- Bachelor's degree or above in Mechanical Engineering, Materials Science, Biomedical Engineering, Quality Management, or related fields
- Minimum 2 years of quality engineering or management experience in the medical device or related industry
- Solid knowledge of ISO 13485 and GMP regulations
- Proficient in DHR review processes and failure analysis methodologies
- Strong problem-solving skills
- Skilled in quality tools (FMEA, SPC, 8D, QC tools)
- Advanced data analysis skills
- Excellent English reading, writing, and speaking skills
Insulet Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Insulet and has not been reviewed or approved by Insulet.
-
Healthcare Strength — Healthcare coverage is broad, including medical, dental, vision, life and disability insurance, wellness resources, and an EAP. Plan details are described as comprehensive, with PPO options and first-day eligibility noted in some cases.
-
Retirement Support — Retirement programs include a 401(k) with a company match equal to 50% of the first 6% of pay, with vesting after a year. This match is paired with other financial benefits and is characterized as a strong element of the package.
-
Equity Value & Accessibility — An ESPP with a 15% discount and a look-back enables stock purchases at 85% of the lower offering-period price. This feature is presented as a notably attractive wealth-building benefit.
Insulet Insights
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
