Program Manager

Job Title: Program Manager







Location: Batesville, Indiana, USA







Duration: 13 Months







Employment Type: Contract







Pay Rate: $60/hr (DOE) on W2

Job Summary
We are seeking an experienced Program Manager to lead process simplification, operational excellence, and AI-enabled transformation initiatives within a regulated medical products environment. This role will partner with R&D, Product Development Engineering (PDE), Quality, Regulatory, and cross-functional teams to streamline workflows, improve efficiency, reduce rework, and strengthen compliance while maintaining patient safety and product quality.

The ideal candidate will bring extensive experience in medical device product development, quality systems, Lean Six Sigma, and process improvement, along with practical experience applying AI and automation to regulated business or technical workflows.

Job Description

• Assess and map end-to-end product development, quality management system (QMS), and related business processes to identify inefficiencies, bottlenecks, redundant documentation, and improvement opportunities.

• Lead cross-functional process improvement and transformation initiatives across R&D, Quality, Regulatory, Engineering, and other business functions.

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

• Apply Lean, Six Sigma, value-stream mapping, and other process optimization methodologies to improve efficiency and deliver measurable results.

• Identify and implement practical AI and automation use cases for document drafting, review, search, data preparation, traceability, and knowledge retrieval.

• Establish appropriate governance, human review, documentation, and controls for AI-enabled workflows in regulated environments.

• Partner with Quality and Regulatory teams to ensure process improvements align with design controls, change control, quality system requirements, FDA regulations, and ISO 13485.

• Lead pilots, measure before-and-after performance, document lessons learned, and refine solutions before broader implementation.

• Develop and update procedures, job aids, reusable process templates, and training materials to support adoption and sustainability.

• Establish performance metrics, track progress, identify risks, and communicate recommendations and results to R&D PMO leadership and senior stakeholders.

• Facilitate stakeholder alignment, manage competing priorities, and drive change across a matrixed organization without relying on direct authority.

• Demonstrate measurable improvements in development cycle time, process effort, rework reduction, compliance, and user adoption.

Job Requirements

• 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, preferably medical devices or other regulated product environments.

• Strong knowledge of design controls, change control, design history documentation, quality management systems, FDA Quality System requirements, and ISO 13485.

• Proven success leading end-to-end process improvement, continuous improvement, or transformation initiatives across multiple functions, sites, or business units.

• Expertise in Lean, Six Sigma, value-stream mapping, or equivalent process optimization methodologies.

• Practical experience applying AI and automation to business or technical workflows, preferably in a regulated environment.

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

• Ability to assess process performance, establish metrics, quantify inefficiencies, and deliver measurable improvements.

• Strong understanding of process mapping, workflow redesign, change management, and implementation planning.

• Excellent communication, facilitation, stakeholder-management, and problem-solving skills.

• Ability to influence senior leaders, engineers, Quality professionals, Regulatory partners, and other stakeholders in a matrixed environment.

• High degree of independence, accountability, and adaptability when managing complex initiatives and competing priorities.

Preferred Qualifications

• Advanced degree in a relevant discipline.

• Lean Six Sigma certification or equivalent demonstrated expertise.

• Experience implementing AI-enabled solutions in regulated product development or quality workflows.

• Demonstrated success reducing development cycle time, process effort, documentation burden, and rework.

Success Measures

• Completion of current-state process mapping and a prioritized improvement roadmap.

• Successful redesign and piloting of high-priority processes.

• Implementation of selected AI and automation use cases with appropriate governance.

• Measurable improvements in cycle time, effort reduction, rework, adoption, and process compliance.

• Sustainable transition of improved processes to business owners.