Insulet Corporation · 2 weeks ago
Senior SW Design Quality Assurance Engineer, Cloud SW (Hybrid)
Massachusetts, United States
Full-time
Hybrid
Mid, Senior Level
$85K/yr - $128K/yr
5+ years expInsulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform. The Senior SW Design Quality Assurance Engineer will ensure new products conform to quality regulations and standards while collaborating with cross-functional teams on cloud-based product development projects.
Health CareMedicalMedical Device
Responsibilities
Ensures new product introduction quality deliverables are created and properly executed (e.g. Project Quality Plan and Risk Management Plan)
Works with teams to establish measurable, valid product requirements
Supports Risk Management activities from product Concept through Commercialization
Supports DHF content completion, integrity, and regulatory and standards compliance, including identifying gaps, collaboratively communicating and working with team to resolve gaps
Reviews and approves design control documentation (e.g. plans, protocols, reports) ensuring compliance with the Insulet Quality System, Quality System Regulation, ISO 13485 and ISO14971
Supports the review of environment qualification activities and deliverables (Installation Qualification/Operational Qualification)
Provides guidance as needed to assure country specific compliance to the laws and regulations of the targeted market for distribution
Supports deployment for cloud releases supporting new products and product changes
Provides project direction, coaching, and mentoring for engineering and technical team personnel
Apply sound, systematic problem solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues
Performs other duties as required
Qualification
Required
A minimum of 5 years work experience in Software Quality Engineering within an FDA regulated environment
Degree in engineering/scientific/computer systems or equivalent experience
Experience with medical device software development
Experience with software development lifecycles
Experience in creation and/or maintenance of quality documentation (SOPs, Templates)
Experience and knowledge of FDA Quality System Regulations 21 CFR 820, ISO 13485, ISO 14971, IEC 62304
Experience utilizing QMS PLM tools
Experience with Non-Product Software Tool validation
Familiarity with various software development tools (e.g., configuration management, issue/defect tracking, requirements analysis, etc.)
Excellent verbal and written communication skills
Ability to collaborate with individuals at multiple levels across the 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
Preferred
ASQ, CSQE or other software quality certificates is a plus
Masters degree preferred
Experience supporting cloud-based system as part of a medical device
Knowledge of AWS is a plus
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