Sr. Design Assurance Engineer
About The Position
The Sr. Design Assurance Engineer supports design assurance activities for Bracco Medical Technologies products, providing support for design verification and validation while ensuring compliance with company design control procedures, applicable regulations, and external standards. The role provides hands-on technical Quality Engineering support for new and existing products, including development of quality requirements and plans, design and process validation requirements, test method validation, and ongoing change management for finished-device manufacturing. The position works across the product lifecycle to help ensure products continue to perform as designed. The engineer provides quality guidance to product development teams, drives the Design Control process, and develops Design and Development Files. Responsibilities include assessing verification plans and reports, managing risk activities, supporting testing qualification and statistical methods, generating quality deliverables, reviewing project materials and change orders, and ensuring external design and test organizations meet Design Control and supplier-control requirements. The role also supports regulatory submissions, documentation, project planning, and communication with management. Travel is expected to be less than 10%.
Requirements
- Bachelor of Science degree in Computer Science, Engineering (electrical or mechanical), or a comparable science discipline.
- At least 5 years of Quality Engineering experience in the medical device industry.
- Extensive knowledge and effective application of quality tools, such as Six Sigma, DOE, process analysis and capability, FMEA, and FTA.
- Extensive knowledge of ISO 13485 quality system requirements and FDA quality system regulations under 21 CFR 820.
- Extensive knowledge of risk management and ISO 14971.
- Strong written and verbal communication skills, including the ability to translate ideas, concepts, and information effectively.
- Ability to develop clear, concise, and timely oral and written reports.
- Ability to support critical projects requiring advanced problem-solving skills and project-management oversight.
- Ability to travel domestically and internationally.
Nice To Haves
- Advanced degree in Computer Science, Electrical Engineering, or Mechanical Engineering.
- Quality Engineering experience with medical devices that incorporate software or products that are software as a medical device (SaMD).
- Demonstrated project-management skills to plan, conduct, and implement system assessments.
Responsibilities
- Provide direction and technical expertise to product development teams regarding quality characteristics and conformance to requirements for medical devices and software as a medical device (SaMD).
- Drive the Design Control process and develop the Design and Development File (DDF) within regulatory requirements.
- Ensure specifications and requirements are relevant, capable, complete, compliant with applicable standards, and testable and verifiable.
- Guide and support design verification activities; assess protocols and reports for test robustness, traceability, statistical sample sizes, and test-specification quality.
- Own risk management activities, including planning, analysis, verification, reporting, and acceptance for assigned areas.
- Support testing qualification, interpretation of technical standards, and selection of statistical methods, including sample-size determination.
- Generate quality assurance deliverables to meet project scope and plans.
- Review, provide input on, and approve project-related deliverables and change orders.
- Work with external design and test organizations to fulfill Design Control requirements and establish appropriate supplier controls.
- Document and report defects found during testing and work with development teams to resolve them.
- Review Design and Development Files and Technical Files for conformance with applicable requirements.
- Prepare technical sections of regulatory approval applications by identifying testing needed for global submissions and applicable U.S. and non-U.S. product and safety standards.
- Maintain rigorous documentation throughout new product development, including specifications, verification and validation test plans, and change orders for medical devices and consumable products.
- Communicate routinely with peers and supervisors, documenting work, meetings, and decisions.
- Maintain project plans, manage milestones, deliverables, and budgets, and oversee a limited number of concurrent projects.
- Clearly communicate deliverables, plans, timing, and objectives to management.
- Travel domestically and internationally as needed; expected travel is less than 10%.
Benefits
- Paid time off and company holidays.
- Paid family leave for parents, grandparents, and eligible family members.
- Annual incentive plan.
- 401(k) savings plan contributions.
- Medical, dental, vision, and life insurance.
- Employer HSA contributions.
- Employee assistance program.
- Short-term disability coverage.
- Tuition reimbursement.
- Structured on-the-job learning, workshops, and seminars.
- Flexible scheduling where possible.
- Hybrid or in-office working arrangements depending on position requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
