R&D Process Excellence Consultant(Medical Device)

Cube Hub Inc.; Batesville (IN); On-site; USD 140,000 - 190,000; Full time

Job summary

Cube Hub Inc. seeks a Senior Consultant, PDE & R&D Process Simplification to lead a 12-month initiative across CCS, simplifying end-to-end product development processes while reducing burden and improving speed, quality and regulatory compliance.

You will partner with R&D, Quality, Regulatory and other functions to drive governance and AI-enabled improvements with measurable impact. This high-visibility role requires credibility with engineers, process owners, auditors and senior leaders,

Qualifications

• Bachelor’s degree in engineering, science, quality, operations, business or related field.
• Typically 15+ years of experience in product development, quality systems, operational excellence, process engineering or program management.
• Lean Six Sigma certification or equivalent mastery preferred.
• Experience in regulated medical products and quality/regulatory expectations (FDA QSR, ISO 13485).
• Experience leading cross-functional transformation in matrixed organizations.

Responsibilities

• Map and optimize PDE, QMS, and related processes across R&D.
• Develop a prioritized PDE simplification and AI opportunity roadmap.
• Redesign high-priority processes to remove steps and clarify ownership.
• Align PDE practices with Quality and Regulatory requirements before pilots.
• Clarify ownership, decision rights, roles, and interfaces across processes.
• Identify and implement AI/automation opportunities with governance.
• Establish governance and controls for AI-enabled processes in regulated environments.
• Lead pilots, measure outcomes, and capture lessons learned.
• Develop updated procedures, job aids, patterns and training materials.
• Provide progress updates and risk/decision reporting to R&D PMO leadership.

Skills

Process improvement

Lean Six Sigma

Stakeholder management

Change leadership

Regulatory knowledge

Cross-functional leadership

Communication

Project governance

AI governance

Facilitation

Education

Bachelor’s degree in engineering, science, quality, operations, business or related field

15+ years in product development/quality systems

Lean Six Sigma certification

Job description

Senior Consultant, Product Delivery Excellence & R&D Process Simplification

Your Role

As the Senior Consultant, Product Delivery Excellence (PDE) & R&D Process Simplification, you will lead a focused, 12-month effort to simplify the end-to-end processes that shape product development across CCS. You will partner across R&D, Quality, Regulatory and other functions to reduce process burden, clarify ownership, improve alignment between PDE and the Quality Management System (QMS), and apply governed automation and artificial intelligence where they measurably improve speed, quality and compliance. This highly visible role requires the credibility to work effectively with engineers, process owners, auditors and senior leaders while driving sustainable change without direct authority.

What You’ll Do

• Assess and map end-to-end PDE, QMS and related business processes that affect R&D, working with the teams who execute them 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 while preserving 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 activities such as 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.

Key Deliverables and Measures of Success

• First 90 days: Complete a current-state map of priority PDE and QMS flows, quantify the most significant friction points, and align stakeholders on a prioritized simplification and AI opportunity roadmap.
• Months 4-9: Redesign and pilot two to three processes end to end; deploy selected AI use cases with governance in place; and release updated procedures, tools and training.
• Months 10-12: Demonstrate measurable reductions in development cycle time, process effort or rework; document adoption and control effectiveness; and transition ownership with a sustaining plan.
• Core measures: Cycle time, effort removed, rework reduction, adoption, process compliance, user feedback and sustainability of results.

What You’ll Bring

• Deep knowledge of medical device or other regulated product development, including design controls, change control, design history documentation and quality system requirements.
• 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, with a record of delivering measurable results.
• 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, including the 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, sound judgment and accountability for results in an ambiguous, cross-functional environment.
• Commitment to mission, patient safety, quality and leadership expectations.

Education and Experience

• Bachelor’s degree in engineering, science, quality, operations, business or a related field required; advanced degree preferred.
• Typically 15 or more years of experience in product development, quality systems, operational excellence, process engineering, program management or a related discipline, including significant experience in the medical products industry.
• Experience leading complex, cross-functional transformation or continuous-improvement initiatives in a matrixed organization.
• Working knowledge of applicable medical device quality and regulatory expectations, such as FDA Quality System requirements and ISO 13485.
• Lean Six Sigma certification or equivalent demonstrated mastery preferred.
• Experience with validated systems, regulated digital tools, data governance or AI governance preferred.

Working Relationships

This role reports to CCS R&D PMO leadership and works directly with R&D, PDE, Quality and Regulatory process owners. The consultant will also engage cross-functional partners in Operations, Manufacturing, Supply Chain, Marketing, Medical, Service, Information Technology, Data Privacy and other functions whose processes affect product development.