Senior Medical Device Program Manager — Process Excellence

MethodHub; Batesville (IN); On-site; USD 150,000 - 190,000; Full time

Job summary

MethodHub is seeking an experienced leader to drive end-to-end PDE and QMS improvements in medical device product development. You will guide cross-functional teams across R&D, Quality, Regulatory, and Operations to streamline processes and ensure regulatory compliance.

The role requires 15+ years in related disciplines, deep regulatory knowledge, and a proven track record of delivering measurable improvements using Lean, Six Sigma, and AI-enabled workflows.

Qualifications

• Bachelor's degree required in a relevant field.
• 15+ years in product development, quality systems or process excellence.
• Significant medical products industry experience.
• Experience with validated systems, regulated digital tools, data governance, or AI governance.
• Lean Six Sigma certification or demonstrated mastery (preferred).
• Strong knowledge of regulatory and quality frameworks (FDA/QSR, ISO 13485).
• Ability to lead cross-functional transformations in matrixed environments.
• Proven ability to drive measurable process improvements and automation initiatives.

Responsibilities

• Lead end-to-end process improvement across PDE, QMS, and related workflows.
• Map current-state processes, identify friction points, and prioritize simplificationRoadmaps.
• Pilot and deploy AI-enabled processes with governance and controls.
• Develop procedures, training materials, and reusable patterns for sustained value.
• Partner with Quality and Regulatory leaders to ensure compliance in new designs.

Skills

Regulatory & Quality Knowledge

Medical device development

Design controls

Change control

Design history documentation

Quality system requirements

FDA QSR & ISO 13485

Process Improvement

Lean / Six Sigma

Value-stream mapping

AI governance / automation

Cross-functional leadership

Stakeholder management

Metrics & data analysis

Executive communication

Independence & accountability

Education

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

Advanced degree (preferred)

Job description

MethodHub is seeking an experienced leader to drive end-to-end PDE and QMS improvements in medical device product development. You will guide cross-functional teams across R&D, Quality, Regulatory, and Operations to streamline processes and ensure regulatory compliance.

The role requires 15+ years in related disciplines, deep regulatory knowledge, and a proven track record of delivering measurable improvements using Lean, Six Sigma, and AI-enabled workflows.