Designs, develops, tests and documents embedded system software for new and existing Insulet products.
Ensures that their design is in compliance with Company policies, and that software activities are appropriate for the design and maintenance of medical products.
Collaborate with Development, QA and IT teams.
Work closely with the software development team to identify and correct defects.
Participate in product design reviews.
Perform other duties as required.
Requirements
BS in Software Engineering, Computer Science or similar field; 10+ years of experience in software design and software testing. Master’s degree preferred.
Experience with medical device software development.
A minimum of 5+ years work experience in Software Quality Engineering within an FDA, ISO or other regulated environment.
Experience on processors like ARM, TI and MSP (or similar Embedded Systems/Microcontrollers) is required.
Experience with software design V&V, computerized systems validations, and process validations.
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.
Hands-on experience with Embedded Systems is required.
Self-motivated, proactive and quick learner.
Benefits
Hybrid working arrangements (requires on-site work from our Acton, MA office; may work remotely other days)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
embedded system softwaresoftware designsoftware testingsoftware quality engineeringV&Vcomputerized systems validationprocess validationARMTIMSP