CY9
Manager Software QA Engineer R&D
Acton, MA | $78K - $160K
Qualifications
- 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 of 1+ years being the Software QA Lead/Manager
- Thorough understanding of software quality assurance principles, practices and metrics as well as software development and testing best practices that foster high quality software
- Hands on experience using modern software development and quality assurance tools
- Proven record developing and executing software test protocols for complex medical devices
- Effective verbal and written communication skills
- Able to communicate at multiple levels of an organization
- Deep knowledge of embedded software testing (black-box, white-box and code Inspection)
- Strong written, verbal, interpersonal and presentation skills
- NOTE: This position is eligible for hybrid working arrangements (requires on-site work from office at least 1x/week; may work remotely other days)
Responsibilities
- This position is responsible for leading Embedded Software Quality Assurance activities throughout the Software Development Lifecycle for new product development initiatives
- This includes ensuring that the software development process is compliant with applicable standards, regulations and guidance documents for medical devices
- 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
- Manage a team of 4-8 embedded software Quality assurance engineers
- 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
- Responsible for the generation, review and approval of design control documentation with primary focus on software development deliverables
- Collaborate with Project Management to support and optimize the schedules
- Support development teams on the validation of software tools
- Work with software, hardware, user experience, marketing, manufacturing, and quality assurance on generation, documentation, verification and validation of requirements
- Establish and maintain software quality assurance programs, processes, procedures and controls to ensure compliance with FDA regulations and established standards such as IEC 62304
- Ensures compliance to IEC 62304, and FDA Guidance on Software Contained in a 510(k) Submission
- Provide guidance on and participate in software development activities including design and code reviews, requirements analysis and tracing, defect tracking and configuration management, Review requirements, specifications, product design documents, validation protocols, test plans, test cases, and other documentation as required and provide timely feedback
- 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
- Work closely with the software development team to identify improvements
- Influence the requirements definition and software design to maximize testability
- Oversee and influence development of test objects to meet needs of protocol
- Develop and extend protocols and plans as device features evolve
- Represent SQA in the core team meetings
- Creating and executing test plans, test designs and test cases and generating test reports for them
- Creating and updating Trace matrices between requirements and Tests
- Work with the scrum Master and product owners to prioritize or deprioritize the backlog
- Keep track of the Testing board and tools inventory for the team
- Performs other duties as required
- 11-50 employees
- Retail, Finance, Technology, Healthcare, Automotive
- Privately Held
- Lewisville, Texas
- Company Specialties:
Cybersecurity, Deep Tech, Tech Sales, Recruiting, H1b Jobs, Cybersecurity Recruiting, and Tech Talent Hiring
Company information
CY9 is a talent assessment firm specializing in Cyber Security, Deep Tech, Enterprise, and Tech Sales. We have a deep contextual understanding of the technical requirements of our clients, the industry, its dynamics, and the demands of the landscape. We are Minority Business Enterprise (MBE) certified, Women Owned Small Business(WOSB) Certified, National Women's Business Enterprise Certificated(WBENC), Texas Historically Underutilized Business (HUB) Certified and National Minority Supplier Certified(NMSDC) Over the last 3 years, we have empowered over 150 businesses, 20+ of whom are unicorns, and successfully partnered with over 25 academic institutions, while in our pursuit of connecting the right talent with the right opportunity. With offices in North America and India, we well positioned to connect the best available talent to the right jobs, and employers with the right tech talent, who deliver a powerful contribution to business goals, add critical value and strengthen the culture. Our Vision: To be a premium full-service recruiting platform for cybersecurity jobs. Our Mission: Cybersecurity talent is among the toughest to find. We’re committed to connecting you to the talent you need. Our approach and process: In a cyber security and deep tech driven industry we stay proactive and guide the candidates through the entire selection process, keeping the excitement alive for them to join our clientele. Our commitment to our clients: Our contribution to our clients success is what we aim at and that leads us to be chosen among our competitors. Reach out to us on +1 682-259-3070 or mail sales@cy9.io
