Serve as the process owner for the Design Control & Risk Management process series, ensuring end to end clarity, consistency, and regulatory compliance.
Maintain a systems level view of how Design Control processes interact across the product lifecycle, from concept through post market.
Ensure processes remain scalable across multiple product architectures, technologies, and risk profiles.
Contribute to enterprise harmonization efforts by identifying opportunities for simplification and standardization.
Lead periodic reviews of Design Control and Risk Management procedures to ensure they remain current, effective, and compliant.
Collaborate with document owners to drive controlled updates to SOPs, WIs, and templates.
Coordinate communication, training, and rollout of updated processes across engineering and quality organizations.
Evaluate new or revised processes to ensure seamless integration within the Design Control ecosystem without gaps or conflicts.
Drive cross functional alignment when regulatory changes, business needs, or emerging technologies require process evolution.
Support change management activities such as process mapping, gap assessments, and adoption planning.
Support and maintain QMR KPIs related to Design Control & Risk Management.
Prepare and present monthly and quarterly metric updates and insights to senior leadership, including XLT.
Identify process performance trends, gaps, and improvement opportunities and recommend actions.
Act as the primary representative for the Design Control process series during internal audits, external audits, and regulatory inspections.
Partner with Engineering, Quality, Regulatory, Software, Cybersecurity, Human Factors, Operations, and PMO to ensure consistent use of Design Control processes.
Requirements
Bachelor’s required (preferred field of study: Computer Engineering)
Master's degree would be a plus
10+ years of experience in medical device development, systems engineering, quality engineering, or design assurance.
Deep knowledge of: Medical Device Design Controls (21 CFR 820.30, ISO 13485)
Risk Management (ISO 14971)
Verification & Validation methodologies
Design Transfer
Demonstrated experience as a process owner or SME for regulated processes.
Strong experience supporting internal audits, external audits, and regulatory inspections.
Ability to simplify complex process frameworks and communicate them effectively across cross functional teams.