DESCRIPTION

• Contract position for a Systems Engineer for medical device manufacturing.
• Serve as the final reviewer for all Systems Engineering outputs, including requirements documents, trace matrices, risk files, and verification protocols.
• Ensure all documentation aligns with 21 CFR 820.30, ISO 13485, and internal design control procedures.
• Validate that system-level requirements are clearly defined and consistently linked across the design history file (DHF).
• Identify gaps, inconsistencies, or ambiguities in technical content and work with authors to resolve them prior to release.
• Maintain and apply document standards, templates, and best practices to ensure clarity, completeness, and usability.
• Prepare and finalize documentation as needed to support Quality Management System submissions, ensuring readiness for audits and regulatory reviews.

REQUIREMENTS

• BS Systems Engineering, Biomedical Engineering, or a related technical field.
• Advanced degree preferred.
• Excellent written and verbal communication skills.
• Strong organizational and time management abilities.
• Collaborative mindset with the ability to work independently and cross-functionally.
• Ability to continue to learn about systems engineering and design controls.
• #ERGx

Please refer the Job description for details