Lead Digital Health Quality Engineer

What you'll do

• Drive design controls, DHF management, and software validation throughout the product lifecycle.
• Perform risk management activities including cybersecurity risk assessments per ISO 14971.
• Author, review, and approve QMS documentation to ensure compliance with medical device regulations.
• Manage Corrective and Preventive Action (CAPA) activities including root cause analysis and resolution.
• Support the creation of regulatory submission documentation and participate in internal/external audits.
• Lead continuous improvement initiatives for Design History Files and Risk Management processes.
• Serve as a subject matter expert on SaMD and Digital Health quality requirements for cross-functional teams.

What we're looking for

• A Bachelor’s degree with 6 years of experience, a Master’s degree with 5 years of experience, or a PhD is required.
• Experience in a quality systems environment or an equivalent combination of work experience is required.
• Strong understanding of regulations and standards for software medical devices including IEC 62304, ISO 14971, 21 CFR 820.30, and EU MDR.
• Experience with the creation and maintenance of QMS documents for medical device development.
• Experience with Computer Software Assurance (CSA) and GAMP5 principles for software validation and lifecycle activities.
• Ability to coordinate complex activities and resolve problems using technical and interpersonal skills.
• Strong communication skills and the ability to work effectively with cross-functional teams.
• Familiarity with medical device cybersecurity, AI/ML, connected devices, and digital health emerging technologies is preferred.