Program Manager (R&D PMO, Medical Devices)
Job Description
OperAxis is hiring a Program Manager for a Medical Devices / Healthcare client. Onsite in Batesville, IN, Monday to Friday, 8 AM to 5 PM. 13-month contract. You'll join the R&D PMO to simplify product development and quality processes and bring practical AI and automation into regulated workflows, while protecting patient safety, product quality and compliance. Duration: 13 months Required Skills • 15+ years in product development, quality systems, operational excellence, process engineering or program management. • Significant experience in the medical products industry. • Deep knowledge of regulated product development: design controls, change control and design history documentation. • Working knowledge of FDA Quality System requirements and ISO 13485. • Lean, Six Sigma, value-stream mapping or similar process improvement methods, with measurable results. • Experience leading cross-functional transformation in a matrixed organization. • Experience with validated systems, regulated digital tools, data governance or AI governance. • Strong facilitation, change leadership and stakeholder management. • Excellent written and verbal communication. Preferred Skills • Lean Six Sigma certification or equivalent demonstrated mastery. • Applying AI and automation in a regulated environment. Education Bachelor's degree in engineering, science, quality, operations, business or a related field. Advanced degree preferred.
Responsibilities
- Map end-to-end product development and QMS processes that affect R&D, including cycle time, effort, handoffs and rework.
- Build and maintain a prioritized process simplification roadmap.
- Redesign high-priority processes to remove unnecessary steps, duplicate documentation and unclear handoffs.
- Partner with Quality and Regulatory leaders before piloting or deploying changes.
- Clarify ownership, decision rights, phase criteria and roles across shared processes.
- Identify and implement AI and automation use cases for drafting, review, search, traceability and knowledge retrieval, with governance and human review in place.
- Lead pilots, measure before and after performance and refine solutions before wider rollout.
- Develop procedures, job aids and training so teams can sustain improvements.
- Report progress, risks and recommendations to R&D PMO leadership and cross-functional stakeholders.