Software Quality Engineer

Software Quality EngineerWarsaw, IN - Hybrid role (3 days in office)$55 - $64 per hourABOUT THE ROLEJoin a Fortune 50 Life Sciences company as a Software Quality Engineer, providing quality leadership for a new product project team focused on the development of medical device software systems. In this hybrid role based in Warsaw, IN, you will serve as the subject matter expert in requirements gathering, software risk assessments, test strategy definition, and guiding the team on design controls and defect analysis. You will partner closely with R&D throughout the full development lifecycle—from upstream requirements and risk through mid-stream verification to ongoing compliance and audit readiness. This is a high-visibility opportunity to own quality end-to-end, gain exposure to a full medical device software toolchain, and collaborate cross-functionally with business partners and mentors.WHAT YOU'LL DOSupport the design, development, and testing of medical device software, including Software as a Medical Device (SaMD) productsProvide leadership, guidance, and expertise on software development processes, procedures, and practicesServe as a subject matter expert in requirements gathering, test strategy definition, and design controlsFacilitate documentation and tracking of verification activities, including code review findingsReview test case execution results and manage software defectsFacilitate software risk assessment sessions and own the development of risk documentationSupport regulatory filings and registrations, including 510(k) submissions and Design History File (DHF) creationProvide technical support for audits of software suppliers and consultants, including cybersecurity and threat modeling topicsConduct training on medical device software development processes and quality systems; develop associated work instructionsProvide expertise in applicable industry standards and regulations (e.g., IEC 62304, FDA guidance, FDA Part 11, ISO 13485, EU MDR, ISO 14971, IEC 62366, ISO 27001, HIPAA)Collaborate closely with R&D and cross-functional teams to ensure compliance with industry standards and regulatory requirementsWHAT YOU BRINGBachelor's degree or university degree in Engineering, Computer Science, Information Systems, or Biomedical/Bio-engineering (required)Minimum 4 years of regulated industry experience in quality, new product development, or manufacturing engineeringExperience in the medical device industryProficiency with quality tools, systems, and processes (e.g., Windchill, Polarion, ETQ)Strong interpersonal, organizational, and verbal/written communication skillsAbility to work collaboratively in a team environment and demonstrate leadershipAbility to perform duties in accordance with company policies, procedures, and civil rights requirementsASQ Certification as a Software Quality Engineer or equivalent (preferred)Expertise in applicable industry standards and regulations (e.g., IEC 62304, FDA guidance, FDA Part 11, ISO 13485, EU MDR, ISO 14971, IEC 62366, ISO 27001, HIPAA)Experience supporting regulatory filings and registrations (e.g., 510(k) submissions, DHF creation)Ability to facilitate software risk assessments and develop risk documentationWHAT'S IN IT FOR YOUOpportunity to own quality end-to-end on a high-visibility project for a Fortune 50 Life Sciences companyExposure to a full medical device software toolchain (Windchill, Polarion, ETQ) and hands-on involvementMeaningful mentorship scope and cross-collaborative team and business partnersHybrid work environment (3 days in office)