Insulet Corporation · 16 hours ago
Senior Systems Engineer (Hybrid - Acton, MA)
Acton, Massachusetts
Full-time
Hybrid
Mid, Senior Level
$102K/yr - $154K/yr
6+ years expInsulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Senior Systems Lifecycle Engineer will lead and contribute to the definition, integration, and characterization of innovative product content, driving system engineering activities while ensuring compliance with medical device regulations.
Medical DeviceHealthcareHealth CareMedical
Responsibilities
Serve as a key member of a cross-functional project team consisting of electrical, software, mechanical, manufacturing, and quality engineers to achieve project deliverables
Serves as a system technical expert for design changes to subsystems by driving requirement refinement, performing risk reviews, implementing risk mitigations, and developing system verification plans to verify the design change
Perform functional analysis, timeline analysis, and detailed trade-off studies to drive design improvements and cost-reduction to existing subsystems
Troubleshoot system-level issues, perform root cause analysis, and implement effective solutions throughout the development process
Lead risk management activities, including hazard identification and Failure Modes and Effects Analysis (FMEA), throughout the product lifecycle in accordance with ISO 14971
Ensure that all design and development activities comply with regulatory requirements, including FDA Quality System Regulation (QSR) 21 CFR Part 820, ISO 13485, and IEC 60601
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
Develop, author, and execute comprehensive test plans, protocols, and reports for system integration, verification, and validation
Coordinate testing to ensure compliance with all applicable safety and performance standards
Analyze 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
Analyze and address customer complaints and field issues through risk assessments and technical investigations
Manage device and manufacturing process changes, including documentation updates and risk file maintenance
Guides and offers expertise with peers, providing guidance on systems engineering processes and tools
Effectively communicate technical risks and proposed solutions to program level stakeholders
Qualification
Required
Bachelor degree required (preferred field of study: Biomedical, Electrical, Mechanical, Systems)
4+ years of experience working in the medical device industry/ highly regulated product development industry
6+ years of experience working directly in a Systems Engineering discipline within product development
Proficiency in system-level design, requirements management, and architectural development
Solid understanding of medical device regulations (FDA QSR, ISO 13485) and risk management (ISO 14971)
Demonstrated success in managing programs/projects involving multiple disciplines from development through commercialization
Experience with requirements management software (e.g., Jama, Polarion, Doors) is required
Experience with systems verification/validation, including test method development
Strong analytical and problem-solving abilities
Excellent written and verbal communication skills
Demonstrated ability to collaborate effectively with cross-functional and global teams
Strong organizational skills and attention to detail, particularly for regulatory documentation
Creative out-of-the box thinker who can devise new approaches and processes that meet regulatory needs but adaptive to address business and market needs
Preferred
M.S. (preferred field of study: Engineering, Engineering Management) considered a plus
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.
1001-5000 employees
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
Ashley McEvoy
President & Chief Executive Officer
Ana Maria Chadwick
Chief Financial Officer
Recent News
bloomberglaw.com
2026-02-07
2025-12-20
Company data provided by crunchbase