Design Engineer for Medical Devices

We are seeking an experienced Design Quality Lead to support Digital Health Technology (DHT) and Software as a Medical Device (SaMD) initiatives within a highly regulated medical device environment. This role will provide quality and regulatory oversight for AI-enabled medical technologies throughout the product development lifecycle.

The ideal candidate will collaborate cross-functionally with Quality, Regulatory Affairs, Product Development, and external business partners to ensure compliance with global medical device regulations and quality standards.

Key Responsibilities

• Develop and maintain QMS procedures, SOPs, and guidance documentation supporting Digital Health and SaMD initiatives
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, IVDR, MDR, and IEC 62304 requirements
• Provide quality oversight for Design Control activities including risk management, CAPA, change control, and design reviews
• Support supplier qualification and quality oversight activities for external business partners
• Review and support technical documentation, DHF deliverables, and regulatory submission packages
• Participate in product development activities to ensure quality and compliance requirements are integrated throughout the lifecycle
• Support audit readiness, inspection preparation, and regulatory compliance initiatives
• Collaborate with cross-functional stakeholders to identify and mitigate quality and compliance risks
• Assist in review and response activities for regulatory agency questions and submissions

Required Qualifications

• Bachelor’s degree in Engineering, Science, or related discipline
• 7+ years of Quality or Regulatory experience within medical devices or SaMD environments
• Strong understanding of Design Controls and medical device development lifecycle
• Experience with FDA 21 CFR Part 820, ISO 13485, IEC 62304, MDR/IVDR, and risk management principles
• Experience supporting CAPA, change control, DHF documentation, and regulatory compliance activities
• Strong communication, collaboration, and problem-solving skills
• Ability to work effectively within a matrixed and cross-functional environment

Preferred Qualifications

• Experience supporting AI-enabled Digital Health Technologies or Software as a Medical Device products
• Experience supporting 510(k), PMA, or De Novo regulatory submissions
• Prior experience working with global regulatory and quality teams

Interview Process

2 rounds of virtual interviews.