Staff Systems Engineer – Design Control, Risk Management Process Owner

Role Overview

• 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.

Tech Stack

• Cyber Security

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs