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.

The Global Product Monitoring (GPM) Engineer is responsible for quality activities to ensure current process requirements are met. Interfaces with other Insulet departments (e.g. Operations, and Information Technology, Engineering, and Regulatory Affairs) as well as other external parties on issues related to product support. Effectively processing documents and protocols and ensuring ambiguities and conflicting requirements are resolved.

· Responsible for processing of documentation in specified tool.

· Responsible for processes and systems.

· Conduct investigations and root cause analysis.

· Review and approve documentation, as required.

· Responsible for GPM: quality events, CAPAs, deviations, etc.

· Develop and deliver training for the organization.

· Support Risk Management activities and ensure compliance with standards and regulations.

· Responsible for metrics development and compliance with team targets.

· Performs other duties as assigned.

Minimum Requirements:

· At least 3 years’ experience in a professional role in a medical technology, life sciences, or healthcare setting.

· Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820), ISO 13485 Medical devices – Quality management systems, and ISO 14971 – Application of risk management to medical devices.

· BA/BS

· Demonstrated experience organizing and maintaining large documentation sets.

· Ability to follow up with task owners to close out open items.

· Effective verbal and technical writing skills. Ability to communicate at multiple levels of an organization.

· Knowledge of Microsoft Office programs (e.g. Word, Excel, and PowerPoint)

· Ability to organize and judge priorities.

· Strong attention to detail with excellent grammatical, editorial, and proofreading skills.

Preferred Skills and Competencies:

· Project management skills: timelines, ownership, drive accountability, etc.

· Experience leading/managing improvement projects.

· Ability to problem solve / conduct root cause investigations.

· At least 3+ years of overall work experience in a technical and/or quality/compliance discipline/regulated industry.

· Periodic travel may be required.

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 $65,300.00 - $98,150.00. 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.