• Lead a global team of engineers in the development of inhaler devices, driving lean improvements and collaboration.• Oversee and ensure compliance with global regulatory requirements for product development, including 820.30 and EU MDR standards.• Develop and implement new strategies for platform development of inhaler devices and combination products.• Introduce and manage effective software tools and strategies for use across the global device team.• Build and foster partnerships with local universities to drive innovation and talent development.• Manage program budgets and resource allocation, ensuring alignment with project goals.• Define and execute the device strategy with a focus on short, mid, and long-term organizational objectives.

• Led the development of both short-term and long-term strategic plans for continuous improvement of the Design Controls system, including enhancements to software quality and non-product software procedures, driving greater compliance and operational efficiency.• Spearheaded the creation of a new, streamlined Design Controls training curriculum, reducing training time from a full week to just one day, significantly improving team readiness and productivity.• Took ownership of establishing and maintaining key metrics to ensure compliance and measure the performance of the QMS, using data to drive meaningful process improvements across the organization.• Led the creation of the Product Quality Improvement Plan, guiding a cross-functional team to achieve successful outcomes that enhanced product safety and effectiveness.• Directed and mentored a team of over 35 individuals across sustaining engineering and new product development programs, ensuring alignment with organizational goals and fostering professional growth within the team.• Served as the final escalation point for critical product and process issues related to design controls, software quality, and non-product software, providing decisive leadership in resolving complex challenges.• Led the resolution of complex quality issues during design and development, ensuring that products meet the highest standards of quality and compliance.

• Led cross-functional collaboration with teams across Marketing, Operations, and Technical Development to ensure seamless project execution and alignment with business goals.• Directed CMO site selection, product transfers, device commercialization, and new technology evaluations, overseeing the development of products manufactured at CMOs.• Provided strategic leadership in defining and assessing product requirements, ensuring comprehensive technical coverage and the integration of subsystems.• Identified key deliverables and established documentation frameworks in accordance with SOPs, industry standards, and design controls, ensuring compliance and project success.• Led the review, approval, and execution of critical requirement documents, design specifications, development and characterization plans, verification and validation strategies (including human factors studies), and test protocols for assigned products.• Reviewed and approved process validation reports from CMOs, ensuring adherence to regulatory requirements and supporting successful regulatory filings.• Oversaw design verification and validation processes performed by CMOs, ensuring that device and packaging designs met stringent verification standards.• Directed the resolution of complex quality issues during design and development, providing leadership in troubleshooting and quality assurance.• Led training initiatives, equipping employees with expertise in design controls and risk management to enhance organizational compliance and product quality.• Created, updated, and maintained quality systems documentation for combination product development, driving continuous improvement.• Provided strategic oversight for Quality System Integration, shaping long-term strategies to optimize performance and compliance across the organization

• Provided strategic oversight of key performance indicators, ensuring alignment with quality system compliance and organizational goals.• Led a team of PMQA associates, ensuring timely, accurate execution of all complaint handling activities and maintaining high performance standards.• Directed investigations into serious injuries and deaths, providing decisive leadership in managing critical cases.• Ensured timely and compliant submissions of reports to regulatory bodies, including Field Alert Reports (FAR), Medical Device Reports (MDR), and Adverse Drug Experience (ADE) reports.• Served as the key decision-maker for escalated issues, identifying and addressing high-impact concerns and escalating as necessary to protect product quality and safety.• Partnered with Medical Device QA trainers to develop tailored training plans for direct reports, ensuring team members were well-prepared and compliant with industry standards.• Led internal process improvement initiatives, assigning projects to PMQA team members, and driving continuous improvement in quality, reliability, and cost efficiency.• Spearheaded continuous improvement projects aimed at enhancing product quality, system reliability, and operational efficiency, ensuring strategic alignment with organizational objectives.• Provided leadership in coaching, training, and development for a team of 15 direct reports, fostering a culture of growth, accountability, and high performance.

• Built and led a specialized team from the ground up to provide Design Controls expertise to a global organization, establishing a critical function within the company.• Successfully directed a 12-month initiative to redesign the Design Controls and Change Management System, playing a pivotal role in avoiding a Consent Decree.• Developed and implemented a comprehensive training program to enhance employee knowledge and proficiency in Design Controls, driving compliance across the organization.• Traveled globally to lead the implementation of Design Controls and Change Management, ensuring consistency and compliance across all sites.• Strategically integrated combination product processes and procedures into the existing quality system, enhancing its robustness and alignment with regulatory requirements.• Led ongoing process improvements to ensure the development of safe, effective combination products and devices, fostering a culture of continuous improvement.• Provided leadership in tracking and reporting the health of the change management system, ensuring timely and accurate updates for management review.• Created and managed budgets for both full-time employees and contractors, ensuring resources were effectively allocated to meet short- and long-term organizational goals.• Directed preparations for recertification audits, demonstrating leadership and expertise in ensuring regulatory readiness.• Acted as the primary spokesperson during front-room FDA and NSAI audits, demonstrating strong leadership and communication skills.• Took ownership of audit observations, leading the response efforts to ensure swift and effective resolution.

• Provided strategic leadership in coaching cross-functional teams through issue resolution, fostering a collaborative approach to developing innovative solutions.• Acted as a guest auditor for internal audits of Design Controls, bringing critical insights and leadership to ensure compliance and process optimization.• Served as Systems Lead, directing a team in developing requirements, use cases, system architecture, and FMEAs for new product development, ensuring alignment with organizational objectives.• Led the team to successfully complete requirements development on time, driving accountability and execution across all phases of the project.• Mentored and developed summer interns, assigning meaningful tasks and facilitating their successful completion while fostering professional growth.• Led the planning and execution of product failure reviews for a third-party audit team, ensuring thorough analysis and clear communication of findings.• As Systems Lead, directed the gathering of input from pump simulations with clinicians, summarizing key feedback for the development team to integrate into product improvements.• Played a key leadership role in audit preparation activities for internal, third-party certification, and FDA audits, facilitating teams in identifying process gaps and closing them efficiently.• Led small teams in gathering objective evidence of compliance, ensuring readiness for high-stakes audits and maintaining regulatory excellence.• Led and provided expert oversight to a team of technicians handling critical investigations related to death and serious injury complaints, ensuring thoroughness and regulatory compliance.• Represented the organization by leading on-site device investigations at hospitals, acting as the primary point of contact for customer-requested inquiries.