Senior Consultant – R&D Process Excellence

Spectraforce; Batesville (IN); On-site; USD 120,000 - 160,000; Full time

Job summary

Spectraforce is seeking a Senior Consultant for R&D Process Excellence to lead a 12-month onsite engagement focused on simplifying end-to-end product development processes. You will collaborate with R&D, Quality, Regulatory and other functions to reduce burden, clarify ownership, and apply governance for AI-enabled improvements while maintaining compliance and patient safety.

The role requires extensive experience in regulated product development, Lean Six Sigma and change leadership, with the

Qualifications

• Deep knowledge of medical device or regulated product development incl. design controls and QMS.
• Demonstrated success leading end-to-end process improvement across functions/sites.
• Expertise in Lean, Six Sigma, value-stream mapping or equivalent.
• Experience applying automation/AI to workflows in regulated environments.
• Ability to translate regulatory requirements into clear, efficient ways of working.
• Strong facilitation and stakeholder-management skills with leaders and SMEs.
• Ability to establish metrics, analyze performance and communicate recommendations.
• Excellent written and verbal communication; credibility with engineers and QA.
• Independence, sound judgement and accountability in cross-functional settings.
• Experience in medical products industry and matrixed organizations.

Responsibilities

• Assess and map end-to-end PDE, QMS and related processes across R&D.
• Develop and maintain a prioritized roadmap for process simplification.
• Redesign high-priority processes, preserving patient safety and regulatory compliance.
• Align PDE practices with quality system requirements before changes.
• Clarify ownership, decision rights, roles and interfaces across processes.
• Identify and implement AI/automation use cases for drafting, review and data prep.
• Establish governance and controls for AI-enabled processes in regulated environments.
• Lead pilots, measure performance, capture lessons, and refine solutions.
• Develop updated procedures, job aids and training for sustainment.
• Provide progress updates, risks and decisions to R&D PMO leadership.

Skills

Lean Six Sigma

Process improvement

R&D processes

AI governance

Regulatory compliance

Education

Bachelor's in engineering/science

Advanced degree preferred

Tools

QMS systems

Job description

Position Title: Senior Consultant – R&D Process Excellence

Assignment Duration: 12 Month

Work Arrangement: Onsite

Position Summary

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.

Key Responsibilities

• 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.

Qualification & Experience

• 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 judgement and accountability for results in an ambiguous, cross‑functional environment.
• Commitment to our organization's mission, patient safety, quality and leadership expectations.
• 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.

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.

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.