Design Assurance Engineer II - Software

Why Join Bracco Medical Technologies? We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate, and have fun along the way. Each member of the Bracco Medical Technologies team has the power to make a difference every day. As part of the Quality Assurance team, the Design Assurance Engineer II – Software position will support design assurance activities for BMT products. Primary Duties & Responsibilities Provide direction and technical expertise to product development teams regarding quality characteristics and conformance to product requirements associated with medical devices or software as a medical device (SaMD) products. Drive the Design Control process and own the Design History File (DHF) within the framework of regulatory requirements. Ensure that specifications and requirements are relevant, capable, contain essential elements, and meet applicable standards, and that all requirements are suitably testable and verified. Provide guidance and support for design verification and validation activities. Assess protocols and reports for test robustness, traceability to requirements, and statistical sample sizes, and quality of the test specification. Lead risk management activities from planning, analysis, verification, risk reporting, and acceptance for assigned areas of responsibility. Provide support for testing qualification, technical standards interpretation, and appropriate statistical methods, including sample size determination. Generate QA deliverables to meet the project scope and plan. Review, provide input, and approve project‑related deliverables and change orders. Work with external design/test organizations to ensure Design Control requirements are fulfilled and appropriate supplier controls are in place. Document and report defects found during testing or from post‑market activities; provide risk assessment for defects and collaborate with the development team to ensure they are resolved. Review Design History Files and Technical Files for conformance to applicable requirements. Prepare technical sections of regulatory approval applications by identifying the testing needed to support global submission and identifying relevant U.S. and non‑U.S. product and safety standards. Qualifications (Knowledge, Skills & Abilities) Minimum B.S. in Engineering, Computer Science, Information Systems, or similar discipline. 3‑5 years of experience in product software applications, development, analysis, and/or QA. 3+ years of experience with software validation in a medical device environment. Experience with software development methodologies. Working knowledge of FDA Quality System Regulation, ISO 13485, the Medical Device Directive and medical device regulations. Knowledge and proficiency in the application of AAMI TIR 36, EN 62304, EN 62366, EN 82304, IEC/TR 80002-1, and other standards, regulations and guidance related to validation of software and computerized systems. Demonstrated knowledge and proficiency in the application of 21 CFR Part 11, IPSE GAMP, ISO 14971, and other standards related to software validation. Demonstrated knowledge and proficiency in quality principles and best practices. Strong collaboration skills to effectively communicate with both business and technical teams. Effective oral and written communication skills. Effective technical writing skills. Ability to work independently. Ability to travel both domestically and internationally. Preferred: Advanced degree in Computer Science, Software Engineering, or similar discipline. Preferred: ASQ CSQE (Certified Software Quality Engineer) or similar certification. Preferred: Experience with Agile PLM, Jama, TrackWise and/or SAP. Preferred: Demonstrated project management skills. Preferred: Familiarity with SDLC processes and methodologies, especially Agile methods in medical device software development. Preferred: Experience with cybersecurity and knowledge of HIPAA regulations and GDPR and related data protection policies. Benefits & Rewards Estimated Starting Salary Range: $95,000 - $104,000 (based on salary and market data specific to the position). Paid Time Off and Company Holidays. 100% paid family leave options for parents, grandparents, and eligible family members. Annual incentive plan and 401(k) savings plan contributions. Medical, dental, vision, and life insurance. Employer HSA contributions. Employee assistance program, short‑term disability, and other comprehensive benefits. Structured on‑the‑job learning, workshops, seminars, and tuition reimbursement program. Hybrid or in‑the‑office work arrangement with business casual attire and flexible schedule where possible. Bracco Medical Technologies is an affirmative action/equal opportunity employer. Bracco Medical Technologies desires priority referrals of protected veterans for all openings. Improve people’s lives by shaping the future of prevention and precision imaging. This is our purpose. Our work impacts millions of people worldwide. #J-18808-Ljbffr Acist Medical Systems Inc.