Sr. Design Assurance Engineer

Bracco•Eden Prairie, MN

About The Position

The Sr. Design Assurance Engineer supports design assurance activities for Bracco Medical Technologies products. 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 change management for finished-device manufacturing. It supports design verification and validation while ensuring compliance with company design control procedures, regulations, and external standards. The role works across the product lifecycle to help ensure products continue to perform as designed. The engineer provides quality direction and technical expertise to product development teams, drives design control activities, develops Design and Development Files, supports risk management, and reviews project and technical documentation. The role also coordinates with external design and test organizations, supports regulatory submissions, and manages project plans, milestones, deliverables, and budgets for a limited number of concurrent projects. Travel is expected to be less than 10%, both domestically and internationally.

Requirements

Bachelor of Science degree or higher 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 incorporating software or with software as a medical device (SaMD).
Demonstrated project management skills for planning, conducting, and implementing system assessments.

Responsibilities

Provide direction and technical expertise to product development teams on quality characteristics and conformance to requirements for medical devices and software as a medical device (SaMD).
Drive the Design Control process and develop Design and Development Files (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 test protocols and reports for robustness, traceability, 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 according to 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 to 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.
Communicate routinely with peers and supervisors, documenting work, meetings, and decisions.
Maintain project plans, set and adhere to milestones and deliverables, manage budgets, and oversee a limited number of concurrent projects.
Clearly communicate deliverables, plans, timing, and objectives to management.

Benefits

Paid time off and company holidays.
100% paid family leave options 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.
Tuition reimbursement.
Structured on-the-job learning, workshops, and seminars.
Flexible scheduling where possible.