Program Manager

Hello,

I hope you're doing well.

My name is Jahera, and I’m reaching out from Intellectt Inc. regarding a Program Manager contract opportunity in Batesville, IN (Onsite) with one of our leading clients.

Job Title: Program Manager

Location: Batesville, IN

Job Description:

We are seeking an experienced Program Manager to lead product development process improvement, quality system optimization, and AI-driven workflow transformation within a regulated medical device environment. The ideal candidate will have extensive experience in medical product development, regulatory compliance, Lean Six Sigma, cross-functional program management, and digital process governance.

Key Responsibilities:

• Assess and streamline end-to-end Product Development Engineering (PDE), Quality Management System (QMS), and R&D workflows.
• Map current-state processes, identify bottlenecks, reduce rework, and improve cycle time and operational efficiency.
• Develop and implement process simplification roadmaps aligned with business priorities, compliance requirements, and patient safety.
• Partner with Quality, Regulatory, Engineering, and R&D teams to ensure compliance with FDA quality system requirements, ISO 13485, and design controls.
• Identify and implement AI and automation opportunities across document drafting, review, data preparation, traceability, and knowledge management.
• Establish governance, human review, documentation, and controls for AI-enabled workflows in regulated environments.
• Lead cross-functional improvement initiatives, pilot programs, and transformation projects, measuring results through defined KPIs.
• Develop and maintain updated procedures, process documentation, job aids, and training materials.
• Communicate program progress, risks, recommendations, and results to senior leadership and key stakeholders.
• Ensure sustainable adoption of process improvements through stakeholder engagement, change management, and clear ownership.

Required Qualifications:

• Bachelor's degree in Engineering, Science, Quality, Operations, Business, or a related field.
• Typically 15+ years of experience in program management, product development, quality systems, process engineering, operational excellence, or a related discipline.
• Significant experience in the medical device or regulated products industry.
• Strong knowledge of design controls, change control, design history documentation, FDA quality system requirements, and ISO 13485.
• Proven experience leading Lean, Six Sigma, process optimization, or continuous improvement initiatives.
• Experience with AI, automation, validated systems, digital governance, or regulated workflow transformation.
• Excellent leadership, stakeholder management, communication, and change management skills.

If you’re currently open to new opportunities, I’d be happy to connect for a quick discussion and share more details. You can reply to this email or share your updated resume at [email protected], or feel free to call me at +1 (732) 276-1791.