Senior Design Assurance Engineer

Senior Design Assurance EngineerPay Rate: $43.04/hr – $54.95/hrAbout the RoleA leading medical device manufacturer is seeking a Senior Design Assurance Engineer to support the assessment, remediation, and sustaining engineering of medical electrical equipment and systems. This role plays a key part in ensuring product safety, regulatory compliance, and long‑term performance within a rapidly expanding vascular therapies portfolio.You’ll provide quality engineering leadership across sustaining design assurance activities, including ISO 14971 risk management, verification and validation (V&V), and post‑market quality support. This position is highly collaborative and requires strong analytical skills, technical depth, and the ability to guide cross‑functional teams.Key ResponsibilitiesRisk Management & RemediationSupport remediation teams by evaluating risk documentation and reviewing post‑market records (PIR, CAPA, historical field actions).Lead or mentor project teams through design assurance deliverables, including:Design & Development PlansRisk Management Plans and ReportsDesign Verification & ValidationReliability and Usability Validation PlansDesign ReviewsField AssessmentsDesign ChangesNCEP/CAPA/PIR activitiesTechnical LeadershipDevelop solutions to complex technical challenges requiring creativity, deep analysis, and sound engineering judgment.Influence cross‑functional planning, guide project strategy, and facilitate decision‑making.Communicate effectively across teams and escalate issues when appropriate.Quality & ComplianceEnsure compliance with internal quality requirements and external regulatory expectations.Support internal and external audits and defend design assurance documentation.Contribute to divisional quality goals and continuous improvement initiatives.Required QualificationsBachelor’s degree in Mechanical, Electrical, Biomedical Engineering, or related discipline.5+ years of experience in design assurance, new product development, or similar roles within the medical device or regulated industry.Understanding of IEC 60601 electrical safety standards.Experience with reliability testing.Demonstrated use of quality engineering tools and methodologies.Strong written and verbal communication skills.Experience with ISO 14971 risk documentation.Preferred QualificationsExperience with Class III medical devices.Bachelor’s degree in Electrical Engineering.Previous R&D experience.Strong knowledge of QSR and ISO standards.Broader medical device industry experience.ASQ certification.Additional InformationAssignment ID: 19207‑1Onsite roleCandidates must be authorized to work in the U.S. without current or future sponsorship