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Manager Software QA Engineer R & D (Hybrid)
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Full-time
- This role will interface with other Insulet departments (e.g. Sr. Management, Hardware team, Manufacturing, Quality assurance and Regulatory Affairs) as well as other external parties on issues related to product development, launched product support.
- Lead and manage the embedded Software Quality assurance team ensure Software verification is conducted in accordance to the FDA standards to deliver high quality software.
- Lead Design Control and Software Quality Assurance initiatives to develop appropriate Design History File documents for FDA Class II and Class III medical devices and embedded Software.
- BS in Software Engineering, Computer Science or similar field; 8+ years hands on experience in software quality assurance associated with real time embedded software systems in regulated industry and/or equivalent combination of education and experience.
- Experience working with products from the prototype through 510(k)/ ISO clearance and commercialization is preferred.
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