Program Manager

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Varmoda is seeking a Senior Principal Manager, R&D Process Excellence & AI Enablement to lead enterprise-wide transformation initiatives focused on simplifying product development and quality processes within a regulated medical products environment. This role will drive operational excellence by assessing, redesigning, and optimizing Product Development Engineering (PDE) and Quality Management System (QMS) processes while enabling the responsible adoption of AI and automation technologies. The resource will partner with R&D, Quality, Regulatory, and business stakeholders to improve efficiency, reduce development cycle times, strengthen compliance, and deliver measurable business impact without compromising patient safety or product quality.

Key Responsibilities

• Assess and map end-to-end PDE, QMS, and related business processes that support product development and R&D operations.

• Analyze current-state workflows, cycle times, effort, handoffs, rework, and operational pain points to identify improvement opportunities.

• Develop and maintain a prioritized process simplification roadmap based on business value, compliance risk reduction, cycle-time improvement, and stakeholder readiness.

• Lead the redesign of high-priority processes to eliminate inefficiencies, duplicate activities, unnecessary documentation, and unclear ownership models.

• Ensure process improvements preserve patient safety, product quality, and regulatory compliance requirements.

• Partner with Quality and Regulatory leaders to align product development practices, quality system requirements, procedures, and operational execution.

• Clarify process ownership, decision rights, roles, responsibilities, phase-gate criteria, and cross-functional interfaces.

• Identify, evaluate, and implement practical AI and automation use cases for document creation, review, search, traceability, knowledge management, and data preparation activities.

• Establish governance frameworks, documentation requirements, review controls, and risk management practices for AI-enabled processes in regulated environments.

• Lead proof-of-concept initiatives, pilot programs, and performance measurement activities while capturing lessons learned and refining solutions prior to enterprise deployment.

• Develop and maintain procedures, job aids, reusable frameworks, training materials, and best practices to support sustainable process improvements.

• Drive change management initiatives through stakeholder engagement, facilitation, and cross-functional influence without direct reporting authority.

• Establish metrics, analyze performance data, and communicate recommendations, risks, progress, and outcomes to executive leadership.

• Partner with teams across Operations, Manufacturing, Supply Chain, Marketing, Medical, Service, Information Technology, Data Privacy, and other business functions that support product development activities.

• Ensure long-term adoption and sustainability of process improvements through governance, training, and transition planning.

Required Qualifications

• Bachelor's degree in Engineering, Science, Quality, Operations, Business, or a related field.

• 15+ years of experience in product development, quality systems, operational excellence, process engineering, program management, or a related discipline.

• Significant experience within the medical device, healthcare, life sciences, or other regulated product industries.

• Deep knowledge of regulated product development processes, including design controls, change control, design history documentation, and quality system requirements.

• Working knowledge of FDA Quality System Regulations and ISO 13485 standards.

• Proven success leading complex, cross-functional process transformation and operational excellence initiatives across multiple functions, sites, or business units.

• Demonstrated expertise in Lean, Six Sigma, Value Stream Mapping, and process optimization methodologies.

• Experience with validated systems, regulated digital tools, data governance, and AI governance practices.

• Practical experience applying automation and AI technologies to business or technical workflows, preferably within regulated environments.

• Ability to translate complex regulatory and process requirements into efficient, scalable, and user-friendly operating models.

• Strong facilitation, change leadership, stakeholder management, and executive communication skills.

• Proven ability to influence senior leaders, technical experts, quality professionals, regulatory partners, and auditors.

• Demonstrated experience establishing process metrics, analyzing performance data, and delivering measurable business outcomes.

• Strong analytical, problem-solving, and decision-making skills with a high degree of independence and accountability.

• Excellent written and verbal communication skills.

• Ability to thrive in complex, ambiguous, and highly matrixed organizational environments.

Preferred Qualifications

• Advanced degree (Master's, MBA, Engineering, Quality, Operations, or related discipline).

• Lean Six Sigma Black Belt, Master Black Belt, or equivalent demonstrated mastery.

• Experience implementing enterprise AI governance frameworks and regulated automation solutions.

• Experience leading digital transformation initiatives supporting R&D, Quality, or Product Development organizations.

• Prior consulting, operational excellence, business transformation, or enterprise process improvement experience.

• Experience supporting global, cross-functional organizations within highly regulated industries.

Certifications & Clearance

• Lean Six Sigma Black Belt, Master Black Belt, or equivalent certification preferred.

• Certifications related to Operational Excellence, Quality Management, Program Management, Process Improvement, AI Governance, or Digital Transformation are highly desirable.

• Experience working with validated systems and regulated technology platforms is preferred.

• No security clearance requirement specified.