Senior Director, Design Quality Assurance (Hybrid - Acton, MA.)

We are seeking a highly experienced and motivated Senior Director of Design Quality Assurance to lead our Design Quality Assurance team. This strategic role is critical in ensuring that our medical devices (single use as well as durable equipment) meet our design requirements and are designed and developed in compliance with regulatory requirements and industry standards.   Scope includes standalone software, applications, embedded software, cloud-based solutions, as well as hardware and electronics (PCBAs, electronic devices, etc). This includes electrical and safety testing, shelf life, and durability considerations. 

The ideal candidate will have a strong background in design controls, risk management, and general quality within the medical device industry, with a particular focus on software and digital health technologies.  This role partners closely with the technical and operations teams as well as our partners. 

Responsibilities:  

• Lead and manage the Design Quality Assurance team, providing strategic direction and oversight.  Select, develop, and lead managers and Design Assurance Engineers on design control compliance requirements, ensuring product inputs are clearly defined and design verification and validation activities are appropriate and compliant.  
• Drive risk management activities throughout the development process and through the product life cycle. 
• Lead and support design related (process and product) CAPAs and continuous improvement activities. 
• Ensure a well-functioning feedback loop between issue identification (post market signals, defect review board, etc) and product design improvements.   
• Lead Design Quality Assurance resources as they relate to product launches, appropriately matching skill set of individual direct reports to demands of projects, prioritizing efforts, anticipating technical issues and assuring successful project outcomes. 
• Provide leadership, mentorship, and accountability to Design Quality Assurance staff, fostering a culture of continuous improvement and excellence. 
• Own and lead regular and robust design reviews that provide assessment of issues, risks, and resource requirements for all phases of NPI projects.  Key member of Technical Review Board for design changes. 
• Develop and implement Design Quality Assurance policies and procedures to ensure compliance with FDA, ISO 13485, and other relevant regulations. 
• Participate in oversight of the design control process for software, applications, and cloud-based solutions, including risk management, design verification and validation, and design transfer, collaborating with other quality functions on the latter. 
• Collaborate with cross-functional teams, including R&D, Regulatory Affairs, IT, Commercial, and Strategy, to ensure quality is integrated into all phases of product development.  This includes coordination serving as primary point of contact with external partners in Quality and Design considerations.  
• Partner with engineering teams (New Product Introduction, Life Cycle / Sustaining, Manufacturing, Supplier, Ops Quality Engineering) to drive design related process and product improvements.   
• Partner with commercial and franchise teams to align quality assurance initiatives with business objectives and market needs. Demonstrate a strong “business partner” approach and attitude providing creative and innovative solutions that meet quality standards 
• Support (and conduct where appropriate) internal audits.  Support external audits by regulatory bodies by serving as Subject Matter Expert for Design Controls. 
• Deploy and own Design Controls related metrics to ensure compliance, process efficiency, and continuous improvement.  Use data-based decision making to ensure process is meeting the needs of the business.   
• Promote awareness of design controls, user requirements, risk management, change control, and verification and validation processes across R&D and new development teams.  
• Stay current with industry trends and regulatory changes, particularly in the areas of software and digital health, to ensure the company remains compliant and competitive. 
• Supports the Partner Management Process, ensuring strategic and tactical alignment between Insulet and our key technology partners from a Quality perspective. 
• Performs other duties as required.  

Minimum Requirements: 

• Bachelor's degree in Engineering, Co