Sr Manager, Design Assurance

This role partners cross-functionally with R&D, Regulatory Affairs, Clinical, Manufacturing, Supply Chain, and Program Management to drive quality-focused decision making, risk-based development practices, and efficient execution of development programs. The Senior Manager establishes and maintains Design Assurance methodologies, systems, and best practices aligned with applicable global regulatory requirements and industry standards.

• Establish and maintain Design Assurance processes, tools, and governance supporting compliant and efficient product development.
• Provide strategic and tactical quality leadership across new product development, sustaining engineering, and design change activities.
• Ensure effective implementation of Design Controls, Risk Management, Verification & Validation, usability engineering, and design transfer requirements.
• Drive quality awareness, visibility, and communication across development teams to support functional and business objectives.
• Develop organizational capability through coaching, mentoring, and talent development of Design Assurance personnel.

• Lead Design Assurance activities supporting new product development, sustaining engineering, and lifecycle management.
• Provide oversight and guidance on implementation of Design Controls in accordance with internal procedures and applicable regulatory requirements.
• Lead and develop Design Assurance personnel including resource planning, hiring, performance management, mentoring, and career development.
• Partner with R&D and cross-functional teams to define development strategies that incorporate quality, reliability, manufacturability, and regulatory expectations.
• Provide leadership on development and execution of design verification and validation strategies, including protocol review, traceability, and objective evidence of compliance.
• Ensure robust application of risk management principles throughout the product lifecycle, including hazard analysis, risk evaluation, risk controls, and benefit-risk assessments.
• Guide teams in development of product requirements, design inputs/outputs, acceptance criteria, and design transfer readiness.
• Review and approve key design deliverables including design plans, requirements, risk documentation, V&V documentation, DHF content, and design changes.
• Drive product quality improvements through analysis of product performance, complaint trends, reliability data, and development metrics.
• Facilitate root cause investigations and corrective/preventive action activities associated with design-related issues.
• Collaborate with Manufacturing and Operations teams to ensure effective transfer of product designs into production and commercialization.
• Champion continuous improvement initiatives to streamline product development processes while maintaining compliance.
• Establish and monitor Design Assurance metrics to evaluate development effectiveness, product quality, and organizational performance.
• Support internal and external audits, regulatory inspections, and responses associated with product development activities.

• Bachelor’s degree in Engineering or related technical discipline required; advanced degree preferred.
• Minimum of 8–10 years of progressive experience in medical device Quality and/or Design Assurance roles with demonstrated leadership experience.
• Minimum of 3–5 years of people leadership experience, including management of technical teams.
• Demonstrated experience supporting product development and commercialization under Design Controls in regulated environments.
• Strong working knowledge of applicable regulations and standards including 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR 2017/745, and IEC 60601 (where applicable).
• Experience with Design History File (DHF), risk management, verification and validation, usability engineering, and design transfer activities.
• Strong understanding of statistical methods, reliability engineering principles, and root cause investigation techniques.
• Demonstrated capability in cross-functional leadership, project execution, and decision making in fast-paced development…