Sr. Manager, Design Assurance Engineering

Sr. Manager, Design Assurance Engineering

Lead, mentor, and develop Design Assurance and Supplier Quality teams, fostering a high-performance, globally aligned culture. Set strategic direction and objectives aligned with business goals, regulatory expectations, and innovation priorities. Drive a culture of accountability, collaboration, and continuous improvement across global teams. Act as a key member of the quality leadership team, influencing enterprise-level quality strategy. Own and drive global design quality strategy, ensuring consistency and standardization across regions and sites.

Lead innovation initiatives in quality engineering, including digital QMS, automation, predictive analytics, and AI-enabled tools. Identify and implement best practices to enhance product quality, operational efficiency, and regulatory compliance worldwide. Serve as a thought leader in advancing next‑generation quality methodologies and tools. Oversee quality engineering activities for new product development and design changes, ensuring compliance with design controls (risk management, V&V, FMEA).

Serve as quality approver at design reviews and tollgates, ensuring alignment with FDA, ISO 13485, and global regulatory requirements. Provide oversight for design transfer, process validation, and lifecycle management to ensure sustained product performance and compliance. Influence product and process design decisions to meet customer and regulatory expectations. Own the global Supplier Quality Management program, including supplier qualification, auditing, performance monitoring, and development.

Drive supplier quality improvements using scorecards, KPIs, and structured improvement initiatives. Lead SCAR processes and ensure timely and effective resolution of supplier issues. Lead complex root cause investigations (e.g., 5 Whys, Fishbone, Fault Tree) and drive effective CAPA implementation with systemic improvements. Ensure adherence to global regulatory requirements (ISO 13485, ISO 14971, FDA 21 CFR 820/QMSR, MDSAP, EU MDR). Support internal and external audits and regulatory inspections, ensuring readiness and compliance.

Continuously improve quality systems including CAPA, nonconformance, and risk management processes. Partner with R&D, Manufacturing, Regulatory, and Supply Chain teams globally to integrate quality into all stages of product realization. Serve as the primary quality liaison for design and supplier‑related decisions. Enable successful product scale‑up and commercialization across global markets. Lead implementation and validation of digital quality systems (e.g., eQMS, eDHR).

Promote data‑driven decision‑making through advanced analytics and reporting. Ensure compliance with data integrity and regulatory requirements in digital solutions. Travel up to 15% domestically and internationally to support global operations.

• Bachelor’s degree in Engineering required;
  Master’s degree preferred.
• Minimum 10 years of progressive relevant experience in a highly regulated industry (FDA, ISO) required.
• Minimum 5 years of leadership experience overseeing direct reports required.
• Proven global experience in a matrix environment strongly preferred.
• Experience in medical devices, preferably dental devices or materials strongly preferred.

• Strong leadership presence with the ability to influence across all organizational levels.
• Deep knowledge of FDA regulations (21 CFR 820/QMSR), ISO 13485, design controls, and risk management (ISO 14971).
• Expertise in supplier quality management, including audits, qualification, and SCAR/CAPA processes.
• Experience with validation (IQ/OQ/PQ), statistical methods, and continuous improvement (Lean, Six Sigma).
• Strong problem‑solving and decision‑making skills with a proactive, risk‑based mindset.
• Proficiency in digital quality systems and emerging technologies (automation, analytics, AI).
• Excellent English communication and technical writing skills.
• Professional certifications (ASQ CQE, CQA, Six Sigma Black Belt) preferred.

• Constantly sits.
• Frequently uses hands and fingers.
• Occasionally walks and stands.
• Occasionally bends and stoops.
• Occasionally reaches up/down with arms.
• Occasionally lifts and/or moves up to 5 lbs.

Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.