Leader of Design Assurance - New Product Development

We are seeking a Leader of Design Assurance to join our Peripheral business and play a key role in evolving how we develop products within R&D. In this role, you will operate as a technical leader within product development, advancing design assurance capabilities to enable faster, more predictable, and scalable innovation. You will lead a team of associates and partner across functional teams to develop fit-for-use, high-quality products, ensuring strong technical execution throughout the product lifecycle.Beyond supporting individual projects, you will help build platform-based capabilities that strengthen how R&D operates across the portfolio.

This role is based in Flagstaff, AZ or Phoenix, AZ, with the possibility of a hybrid work arrangement.

• Lead and develop a team of Quality Engineers and Reliability Engineers, along with boundary condition and testing lab capabilities, to advance design assurance and support new product development
• Partner across R&D, Regulatory, Manufacturing, and Product/Process Architecture leaders throughout the product development lifecycle to influence and align product design, and development strategies
• Lead the application of design assurance principles within product development to drive design decisions and improve product performance
• Ensure teams translate user needs into design inputs and establish clear, testable design requirements that enable effective design decisions and robust product performance
• Lead teams and subject matter experts to define and execute Design Verification & Validation strategies, including test method development, design of experiments (DOE), and data-driven analysis
• Ensure design control and risk management support timely, effective design decisions by balancing risk, benefit, and product performance
• Contribute to and drive alignment through technical design reviews to improve product performance, reliability, and manufacturability
• Ensure designs support manufacturing scalability, yield, and long-term performance through effective cross-functional alignment
• Champion development of reusable design assurance assets and shared capabilities that improve efficiency, reduce rework, and enable more scalable product development
• Build and lead an inclusive, high-performing team by setting clear expectations, developing capability, and holding team members accountable for results, while serving as a subject matter expert in Design Control, Risk Management, and Design Verification & Validation

• Bachelor's degree or higher in engineering, science, or a related technical field
• Minimum 10 years of experience in engineering, including minimum of 3 years of direct leadership of technical teams in product development or R&D environments
• Demonstrated experience in product development and design control within new product development, with hands-on involvement in design, test development, and technical decision-making
• Strong background in risk management and design control elements (design inputs/outputs, verification & validation, etc.),
• Strong decision-making skills, with the ability to navigate ambiguity and make complex, high-impact decisions, while driving alignment across teams
• Experience leading or contributing to projects in regulated medical device environments, ensuring regulatory and quality requirements are effectively integrated into product development
• Strong written and verbal communication skills, with the ability to communicate complex technical concepts, influence stakeholders, and drive alignment across teams
• Proven ability to lead and influence cross-functional engineering teams (R&D, manufacturing, quality) to drive alignment and execute effectively
• Ability to analyze and interpret technical data, including application of DOEs or similar methods to support data-driven decision making
• Demonstrated ability to balance technical rigor with speed and practicality in an R&D environment to accelerate product development
• Ability to travel up to 10%

• Advanced degree in mechanical, biomedical, or related engineering field
• Minimum 15 years of experience in engineering, product development, or design assurance, with working knowledge of ISO 13485, ISO 14971, and FDA 21 CFR 820
• Demonstrated success improving product development effectiveness (e.g., cycle time, first-pass success, reduced rework), including experience developing reusable, platform-based approaches or capabilities