[Remote] Senior Design Quality Engineer - Medical Device

Note: The job is a remote job and is open to candidates in USA. TekHawks is seeking a Senior Design Quality Engineer to remediate medical device design documentation and resolve compliance gaps. The role ensures design history files and design control records are complete, traceable, audit-ready, and aligned with FDA requirements and applicable ISO standards.

Responsibilities

• Perform DHF assessments, gap analyses, remediation, and documentation updates to ensure audit readiness and regulatory compliance
• Review and remediate design control documentation, including design inputs, outputs, design reviews, verification, validation, and design changes
• Apply mechanical engineering knowledge to evaluate product design documentation, engineering drawings, specifications, design changes, and verification/validation evidence
• Develop, review, and update risk management documentation, including DFMEAs, hazard analyses, risk assessments, and risk mitigation records in alignment with ISO 14971
• Establish and maintain traceability between user needs, design inputs, design outputs, identified risks, verification, and validation activities
• Identify documentation deficiencies, assess compliance gaps, develop remediation plans, and drive timely closure of corrective actions
• Support CAPA, root cause analysis, and resolution of design-related quality and compliance issues
• Prepare and maintain audit-ready technical documentation to support internal audits, external audits, and regulatory inspections
• Collaborate with R&D, Mechanical Engineering, Regulatory Affairs, Manufacturing, and Quality teams to strengthen design controls and documentation compliance

Skills

• A strong Mechanical Engineering background
• Extensive experience in medical device design controls, Design History File (DHF) remediation, risk management, and regulatory compliance

Benefits

• Remote work (Denver, CO)

Company Overview

Company H1B Sponsorship