Design Assurance Engineer II

Primary Duties & Responsibilities

Design Assurance

• 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.

Qualifications (Knowledge, Skills & Abilities)

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

Preferred

• 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

Other

• Ability to travel both domestically and internationally, at times overnight, may be required. Travel is expected to be less than 10%.

Compensation & Total Rewards

Estimated Starting Salary Range: $95,000 - 104,000

*Estimated Starting Salary Range is reflective of the range Bracco Medical Technologies reasonably expects to pay for the position. The range provided is based on salary and market data specific to the position.

Total Rewards

• Paid Time Off, Company Holidays & Paid Family Leave - We provide PTO and Company Holidays to help you recharge, relax and do what's important to you, when it's important to you. Our 100% paid family leave options for parents, grandparents and eligible family members provide support for growing families as well.
• Achieve - Beyond competitive compensation, we offer options to help you plan for a financially secure future, including an annual incentive plan and 401k savings plan contributions.
• Live well - We offer comprehensive benefit options to help protect you along the way, including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc.
• Evolve - Through structured on-the-job learning, workshops, seminars, and our tuition reimbursement program, you'll find many opportunities to grow, personally and professionally.
• Choose - You won't find "stuffy" here-whether your position requires a hybrid or in-the-office working arrangement. That means business casual for your attire and flexibility in your schedule, wherever possible.