Program Manager

Program Manager

Batesville, IN, USA

13 Months

Must Have

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

Preferably in a regulated environment