Sr. Program Manager Business Professional

Spectraforce Technologies, Inc.; Batesville (IN); Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

Spectraforce Technologies, Inc. is seeking a Senior Consultant for Product Delivery Excellence & R&D Process Simplification in Batesville, IN.

This 12-month, onsite engagement focuses on simplifying end-to-end product development processes across R&D, Quality and Regulatory to reduce burden, improve speed, and ensure compliance. You will lead pilots, define roadmaps, and drive sustainable change without direct authority while collaborating with senior leaders and engineers in a heavily

Qualifikationen

• 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 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.

Aufgaben

• Assess and map end-to-end PDE, QMS and related processes affecting R&D, baseline metrics.
• Develop a prioritized process simplification roadmap based on value and risk.
• Redesign high-priority processes to remove steps and unclear handoffs while preserving safety and compliance.
• Partner with Quality and Regulatory leaders to align PDE practices before piloting or deploying changes.
• Clarify ownership, decision rights, roles and interfaces across shared product development processes.
• Identify, prioritize and implement AI and automation use cases for drafting, review, search, data prep, traceability.
• Establish governance, human review, documentation and controls for AI-enabled processes in regulated environments.
• Lead pilots, measure performance, capture lessons learned and refine solutions.
• Develop updated procedures, job aids, reusable patterns and training materials for sustainment.
• Provide clear recommendations, progress updates, risks and decisions to R&D PMO leadership and stakeholders.
• Lead change through influence, align functions and resolve priorities without direct authority.

Kenntnisse

Process improvement

Lean Six Sigma

Value-stream mapping

Automation & AI

Regulated industry

Stakeholder management

Change leadership

Project management

Cross-functional collaboration

Regulatory knowledge

Ausbildung

Bachelor's degree in engineering, science, quality, operations, business

Advanced degree preferred

Jobbeschreibung

Position Title: Senior Consultant, Product Delivery Excellence & R&D Process Simplification

Work Location: Batesville, IN 47006

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 judgment 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.