Program Manager

Job Title: Senior Program Manager – R&D Process Improvement & Transformation

Location: Batesville, IN

Duration: 12 Months

Industry: Medical Devices / Life Sciences

Experience: 15+ Years

Job Summary

We are seeking an experienced Senior Program Manager to lead R&D process improvement, product development excellence, and business process transformation initiatives within a regulated medical device environment.

The ideal candidate will have strong experience in Medical Device R&D, Product Development, Quality Management Systems (QMS), Design Controls, Lean Six Sigma, and Operational Excellence . This role focuses on simplifying product development processes, improving efficiency, reducing cycle times, and implementing automation and AI-driven solutions while maintaining regulatory compliance.

Key Responsibilities

• Lead end-to-end R&D process improvement and simplification initiatives across Product Development, Quality, Regulatory, and Engineering teams.
• Evaluate existing product development processes, identify inefficiencies, and implement sustainable improvements.
• Develop process improvement roadmaps to reduce cycle time, eliminate redundant activities, and improve operational efficiency.
• Align R&D product development processes with QMS requirements, FDA regulations, and ISO 13485 standards.
• Drive continuous improvement initiatives using Lean Six Sigma, Value Stream Mapping, and process optimization methodologies.
• Support Design Controls, Design History Files (DHF), change control, and product lifecycle management processes.
• Identify and implement automation and AI solutions to streamline documentation, workflows, data management, and process execution.
• Lead cross-functional transformation projects involving R&D, Quality, Regulatory, Manufacturing, and IT stakeholders.
• Establish process performance metrics, monitor KPIs, and demonstrate measurable improvements.
• Develop and update SOPs, process documentation, training materials, and standardized workflows.
• Manage stakeholder communication, organizational change, and process adoption across multiple functions.
• Present project progress, improvement opportunities, risks, and recommendations to senior leadership.

Required Qualifications

• Bachelor's degree in Engineering, Science, Quality, Operations, Business, or a related field.
• 15+ years of experience in Program Management, R&D, Product Development, Quality Systems, or Operational Excellence.
• Strong experience within the Medical Device or regulated product development industry .
• Hands-on knowledge of Design Controls, DHF, QMS, FDA Quality System requirements, and ISO 13485 .
• Proven experience leading enterprise-level process improvement and business transformation initiatives.
• Expertise in Lean Six Sigma, Value Stream Mapping, Continuous Improvement, and Process Optimization .
• Experience managing complex, cross-functional programs and influencing senior stakeholders.
• Strong analytical, problem-solving, change management, and communication skills.

Preferred Qualifications

• Lean Six Sigma Green Belt / Black Belt certification.
• PMP certification or advanced degree.
• Experience implementing AI, digital transformation, and workflow automation solutions.
• Knowledge of validated systems, data governance, and AI governance in regulated environments.
• Experience leading multi-site R&D or Quality Systems transformation programs.