Insulet Corporation · 1 day ago
Staff Design Assurance Engineer (Hybrid)
San Diego, CA
Full-time
Hybrid
Lead/Staff
$115K/yr - $172K/yr
8+ years expInsulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions. This position is responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives and automated data processing systems used as part of the quality system.
Health CareMedicalMedical Device
Responsibilities
Lead Design Control and Software Development initiatives to develop appropriate Design History File documents for FDA Class II and Class III medical devices, mobile applications, cloud-based systems, and cybersecurity
Ensures compliance to IEC 62304, and FDA Guidance on Software Contained in a 510(k) Submission
Support efforts for cybersecurity risk management for both US and Rest of World (ROW) requirements
Support development teams on the validation of software tools
Provide guidance for the generation, review, and approval of design control documentation with primary focus on software development deliverables
Collaborate with Project Management to support the Design Control process and Continuous Improvement initiatives to optimize our SW Development processes
Serve as the Design Control expert to software development organization
Develop and deliver Design Control training for the software development organization
Provide expertise in establishing good software requirements, specifications, detailed design, verification and validation protocols and planning documentation
Review requirements, specifications, product design documents, validation protocols, test plans, test cases, and other documentation as required and provide timely feedback
Support creation of necessary documentation to comply with regulatory requirements and industry best practices
Support execution of Risk Management Activities for complex systems in compliance with ISO14971 and software risk requirements in IEC 62304
Establish and maintain software quality assurance processes, procedures, and controls to ensure compliance with FDA regulations and established standards such as IEC 62304
Provide guidance on, and participate in software development activities including design and code reviews, requirements analysis and tracing, defect tracking and configuration management
Applies a good working knowledge of Software Development Life Cycle (IEC 62304), Design Controls (ISO 13485) and other regulatory requirements and agencies as it relates to Quality Assurance activities in software development. Maintain effective communication with the project software engineers to make sure that user needs, requirements, plans, verification and validation documents, risk assessments, and other documentation is complete
Qualification
Required
BS degree in an engineering, scientific, computer systems, or quality management curriculum or equivalent experience
Experience with medical device software development
Experience with a risk-based approach to validate Commercial off the Shelf (COTS) software and SW Tools
Experience with software mobile applications, cloud-based systems, and cybersecurity
A minimum of 8 years work experience in Software Quality Engineering within an FDA, ISO, or other regulated environment and/or equivalent combination of education and experience
Experience in the development and implementation of effective Design Control Systems
Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485 quality system standards
Working knowledge of IEC 62304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance documents on software development, cybersecurity, and submission requirements for 510(k)
Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.)
Experience with software development lifecycles with emphasis on the software quality engineering aspects
Effective verbal and written communication skills
Experience collaborating and communicating with individuals at multiple levels in an organization
Ability to prioritize and manage critical project timelines in a fast-paced environment. Must be able to handle multiple responsibilities concurrently
Strong analytical and problem-solving skills
Able to work effectively in a high-stress, high-energy environment
Ability to influence people and projects in a fast-moving environment
Preferred
ASQ, CSQE or other software quality certificates are beneficial
Master's degree preferred
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
2025-12-20
2025-12-17
Company data provided by crunchbase