Software Quality Engineer

IPG Medical Corporation is seeking a Software Quality Engineer in Marlborough, MA with the following responsibilities: Provide SW Quality Engineering support for the IPG Medical team during design, development and release to production phases of product development; Provide support throughout the product SW lifecycle by participating in SW development reviews, code reviews and formal SW technical reviews; Document SW specifications, verification/validation testing protocols, risk assessment & analysis, and cybersecurity in accordance with applicable medical device development standards; Ensure SW development activities and deliverables meets the Quality and Regulatory requirements of FDA and ISO standards; Participate in risk assessment activities; Review and approve new and modified SW product designs for quality characteristics, testability and traceable to product requirements, including verification/validation test plans and results; Review and ensure DHF compliance for all SW deliverables; Represent SW Quality for IPG Medical group for internal design and review; Support and interact with other departments, including R&D, technical support, field service, and manufacturing. 

Total Rewards: IPG offers competitive benefit and compensation packages designed to support and retain our employees. Our benefits are thoughtfully tailored to local needs, encompassing: Health and dental insurance coverage, Retirement savings plans, and Bonuses.

Master's degree in Information Technology, Computer Science, or related field or foreign equivalent degree. 3 yrs of related experience.  Required Skills: Manage and build high throughput data pipeline exclusively in linux environment; Develop in-house big data services leveraging AWS tools like EC2, S3, and DynamoDB to assist internal teams in delivering and storing ad metrics data, allowing key stakeholders to make valuable business decisions; Conduct unit and integration testing using C# within a Windows operating system to assess software updates, ensuring alignment with specified requirements and overall system stability; Ensure testing procedures comply with regulatory standards, including FDA guidelines and ISO requirements for medical devices, and use software documentation within the medical field; Leverage Surround SCM to manage and maintain the code repository, implementing version control practices and facilitating collaboration among development teams to enhance code quality and project efficiency; Collaborate with R&D, technical support, field service, and manufacturing teams, while testing and troubleshooting the Production Database (PDB) and related software utilities to ensure smooth operations; Develop and maintain comprehensive documentation—including Software Requirement Specifications, Verification/Validation Protocols, Manufacturing Procedures, and Work Instructions—to support clear and accessible processes; Conduct software verification and validation testing for field application and internal production utility software, ensuring compliance with industry standards. Total Rewards: IPG offers competitive benefit and compensation packages designed to support and retain our employees. Our benefits are thoughtfully tailored to local needs, encompassing: Health and dental insurance coverage, Retirement savings plans, and Bonuses.