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.

• 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.

• 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, Track Wise 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.

• Estimated Starting Salary Range: $95,000 - $104,000 (based on salary and market data specific to the position).
• Paid Time…