Systems Engineering Lead

Location: Bothell, WA (onsite). Visa: Open. Position type: Contract.

Responsibilities

• Act as the onsite Systems Engineering Lead, supporting day-to-day coordination with stakeholders, project teams, SMEs, Quality, Regulatory Affairs, R&D, and leadership.
• Review assigned 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 other systems engineering artifacts to establish a complete and defensible corrected product baseline.
• Ensure product requirements are complete, consistent, testable, traceable, and aligned with applicable quality systems, regulatory requirements, and medical device standards.
• Establish, maintain, and verify traceability between requirements, failure modes, risk controls, test methods, verification activities, and objective evidence.
• Support alignment of FMEA and risk management documentation, ensuring proper linkage between hazards, harms, failure modes, mitigations, risk controls, and verification evidence.
• Review verification records and supporting evidence to ensure compliance with requirements and defined acceptance criteria.
• Populate and maintain corrected product data in Codebeamer to support the remediated project baseline, including requirements, traceability, lifecycle management, and closure readiness.
• Support project reviews, technical discussions, progress updates, issue resolution meetings, and escalation management.

Education & Experience

• Bachelor'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 systems engineering experience in regulated product development.

Required Skills

• Experience in medical device remediation, CAPA support, audit readiness, or regulatory remediation programs.
• Knowledge of medical device quality systems and standards such as ISO 13485, ISO 14971, or equivalent.
• Experience working with global cross-functional engineering teams.
• Familiarity with DHF, risk management files, verification records, defect records, and quality system procedures.
• Prior experience supporting customer workshops, technical reviews, and steering committee updates.