Program Manager

Job Title: Program Manager

Location: Batesville, IN, USA

Experience: 15+ years

Rate: $50/hr

We are hiring a Program Manager on behlaf of our client (RibbitzLLC)

This is for a Senior Director - R&D Process Excellence / Product Development Transformation Lead / Quality Systems & Operational Excellence role at (Medical Devices).

It needs a bachelor's in engineering/science/quality/business (Advanced degree preferred) with 15+ years in product development, QMS, process engineering, program management, significant medical device industry experience, validated systems & AI/data governance, with Lean Six Sigma preferred.

You must have deep expertise in FDA QSR, ISO 13485, design controls, change control, DHF, QMS, plus proven Lean/Six Sigma/value-stream mapping driving end-to-end cross-functional process improvement with measurable results in a matrixed org.

Core work is to assess & map end-to-end PDE/QMS/R&D processes, quantify cycle time/effort/handoffs/rework/pain points, and create a prioritized simplification & AI/automation roadmap based on business value, compliance risk & readiness.

You will redesign high-priority processes to eliminate redundant steps/duplicate docs/unclear handoffs, clarify ownership/decision rights/phase criteria, align with Quality/Regulatory leaders, and preserve patient safety & compliance.

*Required Education*

Bachelor's degree in engineering, science, quality, operations, business, or a related field — required

*Preferred Education*

Advanced degree

*Required Experience*

Typically, 15 or more 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

*Preferred Certification*

Lean Six Sigma certification or equivalent demonstrated mastery

*Required Skills*

Regulatory & Quality Knowledge

Deep knowledge of medical device or other regulated product development

Design controls

Change control

Design history documentation

Quality system requirements

Working knowledge of FDA Quality System requirements and ISO 13485

Process Improvement

Demonstrated success leading end-to-end process improvement across multiple functions, sites, or business units

Expertise in Lean, Six Sigma, value-stream mapping, or equivalent process optimization methods

Record of delivering measurable results

Experience leading complex, cross-functional transformation or continuous-improvement initiatives in a matrixed organization

Practical experience applying automation and AI to business or technical workflows

Preferably in a regulated environment

Ability to translate complex regulatory and process requirements into clear, efficient, and usable ways of working

Strong facilitation, change leadership, and stakeholder-management skills

Ability to influence senior leaders and subject-matter experts

Demonstrated ability to establish metrics, analyze process performance, prioritize opportunities, and communicate recommendations to leadership

Excellent written and verbal communication skills

Credible with engineers, quality professionals, regulatory partners, and auditors

High degree of independence

Accountability for results in an ambiguous, cross-functional environment

Commitment to Baxter's mission, patient safety, quality, and leadership expectations

Assess and map end-to-end PDE, QMS, and related business processes that affect R&D

Work with executing teams to establish current-state cycle time, effort, handoffs, rework, and pain points

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

Redesign high-priority processes to eliminate unnecessary steps, redundant activities, duplicate documentation, and unclear handoffs

Preserve patient safety, product quality, and regulatory compliance

Partner with Quality and Regulatory leaders to align PDE practices, quality system requirements, local procedures, and working-level execution before piloting or deploying changes

Clarify functional ownership, decision rights, phase criteria, roles, and interfaces across shared product development processes

Identify, prioritize, 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 processes in regulated environments

Lead pilots, measure before-and-after performance, capture lessons learned, and refine solutions prior to broader deployment

Develop updated procedures, job aids, reusable patterns, and training materials

Enable process owners and teams to sustain improvements after the engagement

Provide clear recommendations, progress updates, risks, and decisions to R&D PMO leadership and cross-functional stakeholders

Lead change through influence, facilitate alignment across functions, and resolve competing priorities without direct authority

First 90 days: Complete a current-state map of priority PDE and QMS flows

First 90 days: Quantify the most significant friction points

First 90 days: Align stakeholders on a prioritized simplification and AI opportunity roadmap

Months 4–9: Redesign and pilot two to three processes end to end

Months 4–9: Deploy selected AI use cases with governance in place

Months 4–9: Release updated procedures, tools, and training

Months 10–12: Demonstrate measurable reductions in development cycle time, process effort, or rework

Months 10–12: Document adoption and control effectiveness

Months 10–12: Transition ownership with a sustaining plan

Core measures: Cycle time, effort removed, rework reduction, adoption, process compliance, user feedback, and sustainability of results

Reports to CCS R&D PMO leadership

Works directly with R&D, PDE, Quality, and Regulatory process owners

Engages cross-functional partners in Operations, Manufacturing, Supply Chain, Marketing, Medical, Service, Information Technology, Data Privacy, and other functions whose processes affect product development.