Design Assurance Engineer II: Medical Devices

Bracco Medical Technologies; Minneapolis, Saint Paul (MN, MN); On-site; USD 95,000 - 104,000; Full time

Benefits offered by this job

PTO & Holidays

Paid Family Leave

401k contributions

Medical/Dental/Vision/Life Insurance

Tuition reimbursement

Job summary

Bracco Medical Technologies is seeking a Design Assurance Engineer II to support design verification and validation activities and ensure compliance with design control procedures and applicable regulations.

This role partners with product development teams to drive Design Control, manage risk, and provide technical leadership for medical device software and hardware projects in a fast-paced environment.

Qualifications

• 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

Responsibilities

• Provide direction and technical expertise to product development teams regarding quality characteristics and conformance to product requirements associated to medical devices or 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.

Skills

Strong written and verbal komunikasi

Advanced problem solving

Ability to work independently

Project management skills

Agile methodologies familiarity

Education

Bachelor's degree in Engineering or equivalent

Tools

ISO 13485

FDA 21 CFR 820

IEC 60601

UL Standards

AAMI TIR 36

EN 62304

EN 62366

EN 82304

ISO 14971

21 CFR Part 11

GAMP

HIPAA

GDPR

Job description

Bracco Medical Technologies is seeking a Design Assurance Engineer II to support design verification and validation activities and ensure compliance with design control procedures and applicable regulations.

This role partners with product development teams to drive Design Control, manage risk, and provide technical leadership for medical device software and hardware projects in a fast-paced environment.