Design Assurance Engineer II-1

Bracco•Eden Prairie, MN

21h•Hybrid

About The Position

The Design Assurance Engineer II position will support design assurance activities for Bracco Medical Technologies (BMT) products. This role is responsible for providing support for Design Verification and Validation activities while ensuring compliance with BMT design control procedures and applicable regulations and external standards.

Requirements

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 with ISO 13485 quality system requirements and FDA quality system regulations 21CFR 820.
Working knowledge of quality tools (e.g., Six Sigma, DOE, process analysis/capability, FMEA, FTA)
Knowledge of risk management and ISO14971
Strong written and verbal communication skills to effectively translate ideas, concepts and technical information to both internal and external parties, and across all levels of an organization.
Advanced problem solving skills
Ability to develop and deliver clear, concise, and timely oral and written reports to peers and management
Ability to work independently

Nice To Haves

Advanced degree in Electrical Engineering or Computer Science
Quality Engineering experience with medical devices which incorporate electrical, mechanical, and software components
Demonstrated project management skills in order to plan, conduct and implement system assessments
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community
Knowledge of IEC 60601 and UL Standards
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, regulations and guidance related to validation of software computerized systems.
Familiarity with SDLC processes and methodologies, especially the application of Agile methods in the development of medical device software
Experience with cybersecurity, knowledgeable in HIPAA regulations and GDPR, and related data protection policies

Responsibilities

Provide direction and technical expertise to product development teams regarding quality characteristics and conformance to product requirements associated to medical devices or software as a medical device (SaMD) products.
Drive the Design Control process and own the Design and Development File (DDF) 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 test robustness, traceability to requirements, and statistical sample sizes, and quality of the test spec.
Lead risk management activities from planning, analysis and verification, and risk reporting and acceptance for the assigned areas of responsibility.
Provide support for testing qualification, technical standards interpretation, and appropriate statistical methods, including sample size determination.
Generate the 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 the defects and work 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 U.S. and non U.S. product and safety standards.
Rigorous documentation for all phases of new product development including specifications, verification/validation test plans, and change orders associated with medical devices and consumable products.
Routine communication with peers and supervisors including documentation of work, meetings, and decisions.