Manufacturing Program Manager (Medical Devices)

Manufacturing Program Manager (Medical Devices)

Ampa is a pioneering neurotechnology startup developing brain stimulation technology to help eradicate depression . We will improve millions of lives by making this transformative treatment universally accessible. Joining us means you’ll be part of a rapidly growing startup with significant equity opportunities and a major impact on our future.

What to Expect : Working at Ampa is a rare chance to help transform global mental health and save millions of lives — a level of impact that demands deep commitment. Success here requires resilience, adaptability, and the discipline to put in long hours. If you thrive in a high-intensity, fast-changing environment and want your work to truly matter, you may do the best work of your life here.

Role Overview :

We are seeking a Manufacturing Program Manager to be the critical link between Ampa and our contract manufacturing partner. This role is equal parts project manager, problem-solver, and boots-on-the-ground operator. You’ll ensure our manufacturing partner is fully trained, equipped, and capable of producing our devices at the highest quality standards, on time, and at scale. If you are a true Engineer at heart, and love organizing chaos, herding cats, and making complex systems run smoothly — this role is for you.

Responsibilities :

• Production Readiness
• Train our contract manufacturing partner production teams and verify understanding through audits, pilot runs, and documentation checks.
• Ensure manufacturing SOPs are followed consistently and processes are locked in before scale-up.
• Confirm that the manufacturing partner has the proper tools, fixtures, test equipment, and documentation to meet build requirements.
• Oversee pilot builds to validate process readiness prior to full-scale production.
• Quality & Compliance
• Conduct on-site quality audits at our manufacturing partner, verifying adherence to Ampa’s QMS and FDA / ISO 13485 requirements.
• Partner with the Quality & Regulatory Lead to implement CAPAs when deviations occur.
• Oversee manufacturing partner’s adherence to test procedures; review and approve test records.
• Ensure packaging, labeling, and documentation meet regulatory and customer requirements.
• Supply Chain & Logistics
• Monitor inventory levels, lead times, and production schedules; forecast needs in collaboration with the Supply Chain Coordinator.
• Track and resolve component shortages, substitutions, or quality issues.
• Coordinate with Kuro (3PL) to ensure timely shipment of finished devices to customers.
• Identify and implement process improvements to boost efficiency, quality, and cost reduction.
• Collaborate with our manufacturing partner to drive yield improvements and waste reduction initiatives.

What You Bring :

Logistics :

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