Systems Engineer I – Insulet Corporation
Insulet Corporation is the maker of the Omnipod Insulin Management System, a revolutionary tubeless insulin pump technology that has transformed the lives of people with diabetes worldwide. We are hiring a Systems Engineer I at our Acton, MA headquarters to support product development and systems integration.
Responsibilities
- Develop and maintain systems requirements documentation and traceability matrices
- Support integration and verification testing of hardware-software medical systems
- Contribute to risk management documentation (ISO 14971 FMEA, fault tree analysis)
- Work with human factors team on usability engineering and formative studies
- Participate in design reviews and cross-functional product development meetings
- Support regulatory submissions documentation for FDA and international markets
Requirements
- BS in Biomedical Engineering, Systems Engineering, Electrical Engineering, or related field
- 0-2 years of experience in medical device development
- Knowledge of IEC 62304, ISO 13485, and FDA design controls preferred
- Strong systems thinking and analytical skills
- Excellent communication skills; ability to work in Agile development environment
Benefits
- Competitive salary with performance-based increases
- Medical, dental, and vision insurance
- Generous 401(k) match and employee stock purchase plan
- Flexible work arrangements
- On-site gym and wellness reimbursement