Insulet Corporation · 21 hours ago
Assoc Systems Engineer (Hybrid - Acton, MA)
Insulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions. The Associate Systems Engineer will support the definition, integration, and characterization of innovative product content, engaging in system engineering activities while adhering to medical device regulations and quality standards.
Medical DeviceHealthcareHealth CareMedical
Responsibilities
Collaborate with seasoned Systems Engineers on troubleshooting design issues and methods of improvement
Collaborate with cross-functional project teams consisting of electrical, software, mechanical, manufacturing, and quality engineers to achieve project deliverables
Contribute to design changes for subsystems including requirement refinement, risk reviews, risk mitigations, and system verification plans to verify the design change
Support functional analysis, timeline analysis, and detailed trade-off studies to drive design improvements and cost-reduction to existing subsystems
Contribute to troubleshooting system-level issues, perform root cause analysis, and implement effective solutions throughout the development process
Contribute to risk management activities, including hazard identification and Failure Modes and Effects Analysis (FMEA), throughout the product lifecycle in accordance with ISO 14971
Work closely with regulatory affairs and quality assurance teams to prepare and maintain the Design History File (DHF) and other technical documentation for regulatory submissions
Support external audits conducted by regulatory bodies such as the FDA or Notified Bodies
Author engineering build requests with direct responsibility for managing engineering materials
Design and set up bench tests in a lab environment
Author design protocols and reports
Coordinate testing to ensure compliance with all applicable safety and performance standards
Contribute to the analysis of test data, interpret results, and formally document conclusions to verify that design outputs meet design inputs
Provide technical support and expertise to cross-functional teams for post-market surveillance and continuous improvement activities
Contribute to the analysis and aid in addressing customer complaints and field issues through risk assessments and technical investigations
Contribute to device and manufacturing process changes, including documentation updates and risk file maintenance
Highly coachable and receptive to constructive feedback
Open to guidance and mentorship to achieve professional growth
Takes ownership of personal development
Demonstrates the ability to adapt to new technologies and processes
Strong presentation skills for communicating with large groups, both in person and virtually
Qualification
Required
Bachelor degree required (preferred field of study: Biomedical, Electrical, Mechanical, Systems)
Ability to work in a fast-paced, dynamic environment with a passion for continuous learning
Passionate about improving the lives of others
Strong technical writing ability
Experience with lab equipment (testing)
Microsoft office suite (Word, Excel, PowerPoint)
Strong analytical and problem-solving abilities
Excellent written and verbal communication skills
Creative out-of-the box thinker
Must be able to sit or stand for 8 hours a day
Preferred
1+ years of experience working in the medical device industry/ highly regulated product development industry
1+ years of experience working directly in a Systems Engineering discipline within product development
Demonstrates working knowledge of engineering principles and scientific methods
Hands-on and inquisitive, not being afraid to challenge a design
General understanding of medical devices and regulations
Planning and organization skills
Ability to organize and judge priorities in a dynamic environment
Benefits
Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
And additional employee wellness programs
Company
Insulet Corporation
Insulet Corporation (NASDAQ: PODD), 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.
H1B Sponsorship
Insulet Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (58)
2024 (43)
2023 (19)
2022 (33)
2021 (41)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$629.5MKey Investors
DeerfieldOrbiMedAlta Partners
2025-03-18Post Ipo Debt· $450M
2009-03-16Post Ipo Debt· $60M
2007-05-15IPO
Leadership Team
Recent News
bloomberglaw.com
2026-02-07
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