Systems Engineer

Systems Engineering LeadLocation: Bothell, WA, USAJob SummaryWe are seeking an experienced Systems Engineering Lead to support a regulated product development and remediation program in a medical device environment. This role will serve as an onsite technical lead, coordinating with cross-functional stakeholders, engineering teams, subject matter experts, Quality, Regulatory Affairs, R&D, and leadership.The Systems Engineering Lead will focus on product documentation remediation, requirements management, risk management, verification, traceability, and development of a complete and defensible product baseline. The ideal candidate will have strong systems engineering experience within regulated product development, with hands-on knowledge of medical device quality systems and standards.ResponsibilitiesAct as the onsite Systems Engineering Lead, coordinating day-to-day activities with stakeholders, project teams, SMEs, Quality, Regulatory Affairs, R&D, and leadership.Review product documentation to identify gaps, dependencies, acceptance criteria, and required remediation actions in collaboration with SMEs and technical leads.Drive remediation of requirements, design documentation, risk linkages, verification mappings, traceability records, and related systems engineering artifacts.Ensure product requirements are complete, consistent, testable, traceable, and aligned with applicable quality system, regulatory, and medical device standards.Establish, update, and verify traceability between requirements, failure modes, risk controls, test methods, verification activities, and objective evidence.Support alignment of FMEA and risk management documentation, including linkages among hazards, harms, failure modes, mitigations, risk controls, and verification evidence.Review verification records and supporting evidence to confirm requirement compliance and satisfaction of defined acceptance criteria.Populate and maintain corrected product data in Codebeamer to support the remediated project baseline, requirements management, traceability, lifecycle management, and closure readiness.Participate in project reviews, technical discussions, progress updates, issue-resolution meetings, and escalation activities.Collaborate with global, cross-functional engineering teams to support technical alignment and remediation activities.Support customer workshops, technical reviews, and steering committee updates as required.Required QualificationsBachelor’s or Master’s degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related technical discipline.8+ years of relevant engineering experience, including significant experience in systems engineering and regulated product development.Experience with medical device remediation, CAPA support, audit readiness, or regulatory remediation programs.Knowledge of medical device quality systems and applicable standards such as ISO 13485 and ISO 14971, or similar regulated product standards.Experience working with global, cross-functional engineering teams.Familiarity with Design History Files (DHF), risk management files, verification records, defect records, and quality system procedures.Experience supporting customer workshops, technical reviews, and steering committee updates.Experience with requirements management, traceability, verification, risk management, and related systems engineering documentation.Equal Opportunity EmployerWe are committed to providing equal employment opportunities to all qualified applicants and maintaining an inclusive workplace free from unlawful discrimination.ApplicationQualified candidates with relevant systems engineering and regulated medical device experience are encouraged to apply.