Design Assurance Engineer II

Position Overview

Design Assurance Engineer II – responsible for supporting design assurance activities for Bracco Medical Technologies (BMT) products, ensuring compliance with BMT design control procedures and applicable regulations.

• Provide direction and technical expertise to product development teams regarding quality characteristics and conformance to product requirements for medical devices or software as a medical device (SaMD).
• Drive the Design Control process and own the Design and Development File (DDF) within regulatory requirements.
• Ensure specifications and requirements are relevant, capable, include essential elements, meet applicable standards, and are testable and verified.
• Guide and support design verification and validation activities.
• Assess protocols and reports for test robustness, traceability to requirements, statistical sample sizes, and quality of test specifications.
• Lead risk management activities from planning, analysis, verification, risk reporting, and acceptance for assigned areas.
• Support testing qualification, technical standards interpretation, and statistical methods including sample size determination.
• Generate QA deliverables to meet project scope and plan.
• Review, provide input, and approve project-related deliverables and change orders.
• Collaborate with external design/test organizations to meet Design Control requirements and supplier controls.
• Document and report defects found during testing or post‑market activities; provide risk assessment and work with development team to resolve them.
• Review Design History Files and Technical Files for conformance to applicable requirements.
• Prepare technical sections of regulatory approval applications by identifying needed testing to support global submission, including U.S. and non‑U.S. product and safety standards.
• Maintain rigorous documentation for all phases of new product development, including specifications, verification/validation test plans, and change orders.
• Conduct routine communication with peers and supervisors, documenting work, meetings, and decisions.

• Minimum B.S. in Engineering (electrical or mechanical), Computer Science, or comparable science discipline.
• Minimum of 3+ years of Quality Engineering experience in the medical device industry.
• Advanced working knowledge of ISO 13485 quality system requirements and FDA quality system regulations (21 CFR 820).
• Working knowledge of quality tools such as Six Sigma, DOE, process analysis/capability, FMEA, FTA.
• Knowledge of risk management and ISO 14971.
• Strong written and verbal communication skills; ability to translate ideas and technical information across all organization levels.
• Advanced problem‑solving skills.
• Ability to develop and deliver clear, concise, timely oral and written reports to peers and management.
• Ability to work independently.

• Advanced degree in Electrical Engineering or Computer Science.
• Quality Engineering experience with medical devices incorporating electrical, mechanical, and software components.
• Project management skills for planning, conducting, and implementing system assessments.
• Experience handling customer, regulatory agency, or business community inquiries or complaints.
• Knowledge of IEC 60601 and UL Standards.
• Proficiency in applying AAMI TIR 36, EN 62304, EN 62366, EN 82304, IEC/TR 80002‑1, and related standards for software validation.
• Experience with 21 CFR Part 11, IPSE GAMP, ISO 14971, 21 CFR Part 11, and other guidance related to software validation.
• Familiarity with SDLC processes and Agile methods for medical device software development.
• Experience with cybersecurity, HIPAA regulations, GDPR, and related data protection policies.

Ability to…