Systems Engineering Lead

Role and Responsibilities:

1.    Act as a 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 confirm gaps, dependencies, acceptance criteria, and required remediation actions in collaboration with SMEs and leads.

3.    Drive remediation of requirements, design documentation, risk linkages, verification mappings, traceability records, and related systems engineering artifacts to support a complete and defensible corrected product baseline.

4.    Ensure product requirements are complete, consistent, testable, traceable, and aligned with applicable quality system expectations, regulatory requirements, and medical device standards.

5.    Establish, update, 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 appropriate linkage between hazards, harms, failure modes, mitigations, risk controls, and verification evidence.

7.    Review verification records and supporting evidence to ensure they adequately demonstrate requirement compliance and satisfy defined acceptance criteria.

8.    Populate and maintain corrected product data in Codebeamer to support the remediated Project baseline for requirements, traceability, lifecycle management, and closure readiness.

9.    Support regular project reviews, technical discussions, progress updates, issue resolution meetings, and escalation management.

Education & Experience:

1.    Bachelor’s or Master’s degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related technical discipline.

2.    8+ years of relevant engineering experience, including significant experience in systems engineering and regulated product development.

Skills:

1.    Experience in medical device remediation, CAPA support, audit readiness, or regulatory remediation programs.

2.    Knowledge of medical device quality systems and applicable standards such as ISO 13485, ISO 14971, or similar regulated product standards.

3.    Experience working with global, cross-functional engineering teams.

4.    Familiarity with DHF, risk management files, verification records, defect records, and quality system procedures.

5.    Prior experience supporting customer, technical reviews, and steering committee updates.