Sr. Manager Design Quality

Position Summary

We are seeking a Senior Design Quality Engineering Manager to provide quality leadership across product development programs and ensure compliance with quality system requirements throughout the design lifecycle. This individual will partner with R&D, Manufacturing, Regulatory, Clinical, and Program Management teams to drive quality excellence from concept through commercialization.

The ideal candidate will bring approximately 10-15 years of experience in medical device quality engineering, design assurance, or product development quality, including experience leading teams and supporting complex product development programs in a regulated environment.

Key Responsibilities

• Lead Design Quality activities across new product development, sustaining engineering, and product lifecycle management initiatives.
• Provide strategic quality leadership during product development efforts from concept through commercial launch.
• Partner with cross-functional teams to ensure design control and risk management requirements are effectively implemented.
• Oversee design reviews, risk assessments, verification and validation activities, and design transfer readiness.
• Drive quality input into product requirements, design outputs, specifications, and development documentation.
• Ensure compliance with applicable FDA regulations, ISO standards, and internal quality system requirements.
• Support development and execution of product risk management activities, including hazard analysis and FMEA reviews.
• Review and approve design control deliverables and quality-related documentation.
• Lead quality investigations, root cause analyses, and CAPA activities related to product development and design performance.
• Collaborate with Regulatory Affairs on product submissions and regulatory strategy support.
• Develop quality metrics and provide recommendations to improve product development effectiveness and compliance.
• Manage, mentor, and develop Design Quality Engineers and other quality professionals.
• Influence technical and business decisions through risk-based quality leadership.

Qualifications

• Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, or related technical discipline.
• Approximately 10-15 years of experience within the medical device industry, including significant Design Quality, Design Assurance, or Product Development Quality experience.
• Prior people leadership, project leadership, or technical leadership experience.
• Strong knowledge of design controls, risk management, verification and validation, and product development processes.
• Experience working within FDA-regulated and ISO-compliant quality systems.
• Demonstrated ability to provide quality leadership across multiple cross-functional teams and programs.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent communication, collaboration, and stakeholder management abilities.

Preferred Experience

• Class II or Class III medical device development experience.
• Experience supporting global product development programs.
• Familiarity with FDA submissions, regulatory inspections, and external audits.
• Experience utilizing risk management tools such as FMEA, hazard analysis, and fault tree analysis.
• Background supporting design transfer, process validation, and manufacturing readiness activities.
• Six Sigma, Lean, or quality engineering certifications.
• Experience leading quality engineering teams within a product development environment.

Key Competencies

• Design Assurance Leadership
• Risk Management
• Design Controls
• Product Development Quality
• Verification & Validation
• Regulatory Compliance
• Cross-Functional Leadership
• CAPA & Root Cause Analysis
• Strategic Decision Making
• Team Development & Mentorship
• Continuous Improvement
• Stakeholder Influence