Insulet Corporation is looking for a Senior Software QA Engineer to ensure that design changes for on-market and new products are effectively and efficiently verified and validated prior to release, and that these designs meet their requirements. This role is crucial for maintaining the quality and compliance of medical device software throughout its lifecycle.
Requirements
- 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.
Responsibilities
- 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.
- Work closely with the software development team to identify and correct defects.
- Participate in product design reviews.
- Perform other duties as required
Other
- Self-motivated, proactive and quick learner
- Able to work independently with minimum supervision.
- Able to be responsible for designing, implementing, and maintaining a section of a design.
- Detail oriented, with effective verbal and written communication skills.
- Able to communicate with candor and trust at multiple levels of the organization.
