Position Overview
We are seeking a DHF/RMF Remediation Engineer I to support medical device product documentation remediation, primarily focusing on existing Design History Files (DHF) and Risk Management Files (RMF). The ideal candidate will review engineering and quality documentation, identify documentation gaps, improve design traceability, and ensure compliance with applicable medical device regulations and standards.
This role will work closely with Quality, Regulatory, Manufacturing, and Sourcing teams to maintain accurate design records, support product changes, and strengthen design control documentation.
Key Responsibilities
- Review and remediate existing medical device Design History Files (DHF) and Risk Management Files (RMF).
- Identify documentation gaps and ensure traceability between user needs, design inputs, design outputs, and verification/validation evidence.
- Review design rationale, product specifications, inspection records, and risk-control documentation for completeness and accuracy.
- Identify, retrieve, and organize supporting engineering evidence, including design verification, validation, and process validation records.
- Ensure critical-to-quality features and inspection evidence are properly linked to design requirements and product risks.
- Review test methods, clinical evidence, and risk-management documentation to ensure alignment with design requirements.
- Prepare, update, review, and coordinate approvals for DHF/RMF documentation in accordance with established quality procedures.
- Collaborate with cross-functional teams, including Quality, Regulatory, Manufacturing, and Sourcing, to resolve documentation gaps.
- Support regulatory submissions, post-market surveillance investigations, and quality-related activities as required.
- Maintain remediation plans, project timelines, action items, and deliverables while tracking activities through closure.
- Communicate project progress, identify potential risks or delays, and escalate unresolved issues to leadership.
Required Qualifications & Skills
- Bachelor's degree in Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Aerospace Engineering, Aeronautical Engineering, or a related approved engineering discipline from an ABET-accredited institution or global equivalent.
- 3–5 years of full-time engineering experience.
- Working knowledge of ASME GD&T (Geometric Dimensioning & Tolerancing) and its application to product design.
- Knowledge of medical device manufacturing processes, materials, and product design.
- Understanding of medical device quality systems, design controls, regulatory requirements, and applicable industry standards.
- Proficiency in Microsoft Office Suite, particularly documentation and reporting.
- Strong written and verbal communication skills with the ability to collaborate across multiple teams and regions.
Preferred Qualifications
- Previous experience with medical device DHF/RMF remediation and design control documentation.
- Experience working with biologics products.
- Design for Six Sigma (DFSS) experience.
- Proficiency in Cognition Cockpit Platform (Electronic DHF System).
- Working knowledge of statistics, including sample size determination, Design of Experiments (DOE), and null hypothesis testing.
- Experience with Minitab or similar statistical analysis tools.
- Familiarity with global medical device regulatory requirements and standards.
Ideal Candidate Profile
The ideal candidate will have an engineering background with 3–5 years of experience in medical device product development, design controls, or engineering documentation. Candidates with hands-on experience in DHF/RMF remediation, design traceability, GD&T, and medical device quality documentation will be particularly well-suited for this opportunity.