MedTech Process Improvement Manager Lean Six Sigma & AI

Transcend IT Solutions; Batesville (IN); On-site; USD 95,000 - 130,000; Part time

Job summary

Transcend IT Solutions seeks a Program Manager to lead end-to-end medical device product development and process-improvement initiatives in a heavily regulated environment. The role emphasizes design controls, change control, data governance, and AI governance within a cross-functional setting.

Ideal candidates have 15+ years in product development or quality excellence, regulated systems experience, and strong leadership with stakeholders.

Qualifications

• Bachelor's degree in engineering, science, quality, operations, business, or related field—required.
• Advanced degree preferred.

Responsibilities

• Lead end-to-end process improvement across functions, sites, or business units.
• Translate regulatory and process requirements into clear, efficient work methods.
• Establish metrics, analyze performance, prioritize opportunities, and communicate recommendations.

Skills

Regulatory knowledge

Medical device dev

Design controls

Change control

Lean Six Sigma

Quality systems

Education

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

Advanced degree

Job description

Transcend IT Solutions seeks a Program Manager to lead end-to-end medical device product development and process-improvement initiatives in a heavily regulated environment. The role emphasizes design controls, change control, data governance, and AI governance within a cross-functional setting.

Ideal candidates have 15+ years in product development or quality excellence, regulated systems experience, and strong leadership with stakeholders.