About the Role

We are seeking a Leader of Design Assurance to join our Peripheral business team and play a key role in new product development. In this pivotal role, you will be responsible for advancing design assurance capabilities to ensure that products and processes meet regulatory, quality system, and design requirements, while maintaining consistency of technical documentation across product lines and throughout product lifecycles.

This position is based in Flagstaff, Arizona, or Phoenix, Arizona, with the possibility of a hybrid remote work arrangement.

Responsibilities

• Lead a team of experienced Quality and Reliability Engineers to advance design assurance capabilities and ensure compliance with customer, risk management, quality, and Design Control requirements and ensure these are demonstrated and documented in new product development and maintained during commercialization, in alignment with applicable medical device regulatory requirements, product requirements, and business strategy
• Develop deep technical and historical knowledge of product and process requirements and technical documentation within the business, while staying current on industry best practices
• Collaborate with Product Design and Process leaders to ensure products are developed and manufactured in accordance with customer needs, regulatory requirements, and industry standards
• Support NPD Teams in defining design requirements and executing design Verification & Validation activities to improve product launch timeliness, enhance implementation of design requirements, and reduce re-work
• Ensure consistency of Quality Engineering practices within NPD and Commercial Manufacturing Teams, including the execution of Design Control, Risk Management, and technical documentation creation and maintenance
• Develop and sustain subject matter expertise within the business for regulatory inspections, with an emphasis on product information in documentation related to Design Control, Risk Management, Verification & Validation, Device Master Records, and Design History Files
• Set clear expectations for equitable and inclusive behaviors among Associates and act promptly to address any negatively impactful or unfair behavior

Required Qualifications

• Bachelor’s degree or higher in science or engineering and minimum of 10 years’ experience leading engineers and design control activities in support of product development
• Complex project management experience in medical device new product development
• Demonstrated experience in creating and maintaining an inclusive work environment with a clear understanding of equitable practices
• Proven product risk management and mitigation experience
• Demonstrated experience with key elements of design control (inputs, outputs, risk management planning, UFMEAs, DFMEAs, DV, DVAL, etc.)
• Demonstrated success in effectively leading multidisciplinary engineering teams and the ability to collaboratively influence cross-functionally
• Proven track record of clear decision-making and organizational alignment
• Strong knowledge of engineering fundamentals, project practices, user requirements, and the ability to apply this knowledge to manufacturing, product design, and technology development
• Demonstrated ability to analyze and interpret technical data, including Design of Experiments
• Ability to travel up to 15% of the time

Desired Qualifications

• Advanced degree 
• Minimum 15 years of experience focused on quality engineering leadership and design control in support of product development
• Experience driving compliance to standards (FDA, MDR, ISO, etc.) and/or experience in multiple medical device specialties

This position offers a hybrid work arrangement in the country from which the Associate is employed.  Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore’s work arrangement policies.

#LI-DIR