Systems Engineering Lead

Systems Engineering Lead

Location: Bothell, WA, USA (Onsite)

Roles & Responsibilities:

1. Act as the onsite Systems Engineering Lead, supporting day-to-day coordination with stakeholders, project teams, SMEs, Quality, Regulatory Affairs, R&D, and leadership.
2. Review assigned product documentation to identify gaps, dependencies, acceptance criteria, and required remediation actions in collaboration with SMEs and technical leads.
3. 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.
4. Ensure product requirements are complete, consistent, testable, traceable, and aligned with applicable quality systems, regulatory requirements, and medical device standards.
5. Establish, maintain, and verify traceability between requirements, failure modes, risk controls, test methods, verification activities, and objective evidence.
6. Support alignment of FMEA and risk management documentation, ensuring proper linkage between hazards, harms, failure modes, mitigations, risk controls, and verification evidence.
7. Review verification records and supporting evidence to ensure compliance with requirements and defined acceptance criteria.
8. Populate and maintain corrected product data in Codebeamer to support the remediated project baseline, including requirements, traceability, lifecycle management, and closure readiness.
9. 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.