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!
Position Dates: January 6, 2025- June 27, 2025
Job Title: Co-op, Design Quality Assurance Engineering
Department: QA Design
FLSA Status: Exempt
Company Overview
Insulet started in 2000 driven to achieve our mission of enabling 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 who have insulin-requiring diabetes, by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe.
We are looking for highly motivated, performance driven individuals who want to be part of building our Center of Excellence and be at the forefront of our rapidly growing global footprint. We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations. Our continued success depends on it.
Position Overview:
The Design Quality Assurance Co-op will work closely with the DQA team and development teams to support new products and design change initiatives. The Co-op role will be involved in reviewing Design Control documents and Design History File Deliverables to ensure compliance to Insulet procedures and regulatory compliance including FDA 21 CFR 820.30 and ISO 13485. This position will also support generation and processing of document and quality change orders in alignment with Insulet’s Quality Management System as well as support continuous improvement initiatives. This role requires independent work, strong interpersonal skills, and the ability to complete a variety of tasks in a fast-paced environment.
The position requires collaboration with other Insulet departments (i.e., Systems Engineering, Software Engineering, Hardware Engineering, Design Verification and Regulatory Affairs) as well as other functional teams on initiatives related to product development. It will also require interfacing with varying levels of the organization.
Responsibilities:
• Collaborate with the team to review and approve Design Control documents and Design History File (DHF) deliverables for completeness and accuracy
• Support compliance to Design Controls per Insulet Policies and Procedures, review traceability matrices and ensure test to requirements traces are accurate.
• Collaborate with Management to optimize Design Control processes, including updating procedures and entering Quality Change Orders (QCO)s.
• Support Risk Management activities and compliance to standards and regulations
• Support a positive work environment that is energizing and motivating
• Perform other duties as required
Required Skills and Competencies:
• Proficient in Microsoft Office Tools (Word, Excel, PowerPoint)
• Effective verbal and written communication skills
• Ability to work independently and follow direction
• Ability to organize and judge priorities
• Ability to generate and maintain accurate records
Education and Experience:
• Currently enrolled in a BS in Engineering (i.e., Biomedical, Computer, Electrical, Mechanical)
Additional Information
· The position is eligible for remote or hybrid working arrangements, preference for candidates located near Acton, MA and San Diego, CA.
NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). #LI-Hybrid
Additional Information:
The US base salary range for this full-time position is $23.00 - $29.75. 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.
At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
