Sr Manager, Design Assurance

About the role

The Senior Manager 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. They establish and maintain Design Assurance methodologies, systems, and best practices aligned with applicable global regulatory requirements and industry standards.

Responsibilities

• 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.

Essential Duties and Responsibilities

• Lead Design Assurance activities supporting new product development, sustaining engineering, and lifecycle management activities.
• 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.

Qualifications

• 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 environments.
• Working knowledge of Lean, Six Sigma, and continuous improvement methodologies preferred.
• ASQ Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent certification preferred.
• Lead Auditor certification preferred.

Skills

• Quality assurance and control
• Design controls
• Risk management
• Verification and validation
• Usability engineering
• Design transfer
• Statistical methods
• Reliability engineering
• Root cause investigation
• Lean, Six Sigma, and continuous improvement methodologies

Benefits

Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program. Salary Range: $185,000 - $204,000 Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer.