Job Title: Software Design Quality Assurance Engineer Job Description We are seeking an experienced Software Design Quality Assurance Engineer to design, develop, and implement quality assurance procedures for product software for diagnostic devices. The ideal candidate will ensure compliance with regulatory bodies, establish metrics, and work closely with product teams to guarantee software meets business and user requirements. Responsibilities + Design, develop, and implement quality assurance standard operating procedures and processes for all software products to comply with regulatory bodies. + Review and approve test plans and test cases to ensure that software meets desired quality and performance standards. + Issue test record documents to perform software verification by software test engineer. + Develop requirement traceability metrics (from user requirements to functional requirements). + Review and approve software documentation for regulatory submission requirements. + Facilitate design input, design lock, software release ceremonies. + Review and approve software related risk documentation (Safety, Security, and Usability). + Establish metrics to measure quality and performance of existing and new software products. + Monitor and analyze software performance, user feedback, and defects to identify areas for improvement. + Work with product teams to ensure that software meets business and user requirements. + Review verification report at the end of each release. + Review Software Bill of Materials (SBOM) to make sure all Software of Unknown Provenance (SOUP) tools or packages are up to date. + Own software related FDA 510(k) submission documents. + Participate in the design and review of software architecture. + Keep up to date with industry trends and best practices. Essential Skills + Moderate experience in software regulatory environment / medical device software development. + Strong knowledge of IEC, IEC, ISO-IEC, ISO, ISO, FDA 21 CFR Part 820. + Excellent decision-making skills, proficient in providing solutions for complex challenges and good problem-solving using quality tools. + Exceptional verbal, written, and organizational skills. + Ability to work effectively in a fast-paced environment. Additional Skills & Qualifications + Bachelor’s Degree or equivalent in Computer Science, Engineering, or related field. + Medical device experience, preferred diagnostics background (DNA sequencing). + Compliance on product software - develop, test, and verify documentation (risk management, V&V, writing documentation for submission). + Software development lifecycle - understand all steps and ensure compliance across entire lifecycle. + FDA documentation, diagnostic instruments, procedure writing, audit. Work Environment The role offers a dynamic and fast-paced work environment, ideal for individuals who thrive in start-up settings. Benefits include 3 weeks of PTO, sick pay accrual up to 80 hours, and a 2% match on our 401(k) with no vesting period. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.