We are seeking an experienced Program Manager to lead cross-functional process improvement, regulatory compliance, and digital transformation initiatives within a regulated medical products environment. The ideal candidate will have deep expertise in medical device product development, Quality Management Systems (QMS), Lean Six Sigma, and practical applications of AI and automation in regulated workflows.
Required Qualifications:
Bachelor's degree in Engineering, Science, Quality, Operations, Business, or a related field.
Typically, 15+ years of experience in product development, quality systems, operational excellence, process engineering, program management, or a related discipline.
Significant experience in the medical products industry.
Experience with validated systems, regulated digital tools, data governance, or AI governance.
Strong knowledge of FDA Quality System requirements, ISO 13485, design controls, change control, and Design History File documentation.
Proven experience leading end-to-end process improvement and cross-functional transformation initiatives.
Expertise in Lean, Six Sigma, value-stream mapping, or equivalent process optimization methodologies.
Demonstrated ability to deliver measurable improvements in cycle time, efficiency, quality, and rework reduction.
Practical experience applying AI and automation to business or technical workflows, preferably in a regulated environment.
Strong stakeholder management, facilitation, change leadership, and communication skills.
Ability to influence senior leaders and technical experts in a matrixed organization.
Lean Six Sigma certification or equivalent demonstrated expertise is preferred.
Key Responsibilities:
Map and assess end-to-end product development engineering (PDE), QMS, and related R&D business processes.
Establish current-state performance baselines, including cycle time, effort, handoffs, rework, and process bottlenecks.
Develop and maintain a prioritized process simplification and improvement roadmap.
Redesign processes to eliminate unnecessary steps, duplicate documentation, redundant activities, and unclear handoffs while maintaining compliance and patient safety.
Collaborate with Quality and Regulatory teams to align process changes with applicable regulations, quality system requirements, and procedures.
Clarify process ownership, decision rights, roles, responsibilities, and cross-functional interfaces.
Identify and implement practical AI and automation use cases for document drafting, review, search, data preparation, traceability, and knowledge retrieval.
Establish appropriate AI governance, human oversight, documentation, and controls for regulated workflows.
Lead pilots, measure results, refine solutions, and support broader deployment.
Develop updated procedures, job aids, reusable tools, and training materials.
Drive stakeholder alignment, change adoption, and sustainable process improvements.
Provide progress updates, risk assessments, recommendations, and key decisions to R&D PMO leadership.
Establish and monitor metrics for cycle time, effort reduction, rework, adoption, compliance, and sustainability.
