Program Manager

Aventiqo; Batesville (IN); On-site; USD 120,000 - 190,000; Full time

Job summary

Aventiqo is seeking a seasoned Process Improvement leader to drive end-to-end optimization of medical device operations. The role emphasizes Lean Six Sigma, regulatory compliance, and data-driven transformation across multiple functions.

The ideal candidate will hold a bachelor's degree in a related field, 15+ years in product development, quality systems or operational excellence, and advanced expertise in validated systems, AI governance, and change control within the medical products industry.

Qualifications

• Bachelor's degree in engineering, science, quality, operations, business, or related field.
• 15+ years of experience in product development, quality systems, operational excellence, process engineering, program management, or related discipline.
• Significant experience in the medical products industry
• Experience with validated systems, regulated digital tools, data governance, or AI governance
• Lean Six Sigma certification or equivalent demonstrated mastery

Skills

Regulatory & Quality Knowledge

Deep knowledge of medical device

Design controls

Change control

Design history documentation

Quality system requirements

FDA QSR & ISO 13485 knowledge

Education

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

Advanced degree

Job description

Medical device, Process Improvement, Six Sigma

Required Education

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

Preferred Education

• Advanced degree

Required Experience

• Typically, 15 or more years of experience in product development, quality systems, operational excellence, process engineering, program management, or a related discipline
• Significant experience in the medical products industry
• Experience with validated systems, regulated digital tools, data governance, or AI governance

Preferred Certification

• Lean Six Sigma certification or equivalent demonstrated mastery

Required Skills

• Regulatory & Quality Knowledge
• Deep knowledge of medical device or other regulated product development
• Design controls
• Change control
• Design history documentation
• Quality system requirements
• Working knowledge of FDA Quality System requirements and ISO 13485

Process Improvement

• 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
• Record of delivering measurable results
• Experience leading complex, cross-functional transformation or continuous-improvement initiatives in a matrixed organization
• Practical experience applying automation and AI to business or technical workflows