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.
- Continuous Improvement
- 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:
- Bachelor’s degree in Mechanical, Manufacturing, or Industrial Engineering (or equivalent experience).
- 5+ years in manufacturing engineering, new product introduction (NPI), or supplier quality management — ideally within medical devices or other regulated hardware.
- Hands-on experience working with contract manufacturers and third-party logistics providers.
- Strong knowledge of manufacturing processes, assembly line setup, and quality control.
- Familiarity with FDA QSR, ISO 13485, and related regulatory frameworks.
- Excellent communication, project management, and problem-solving skills — comfortable “herding cats” across functions and vendors.
- Willingness to travel frequently to manufacturing/other partners.
Logistics:
- Work Mode: Hybrid or Remote
- Locations: Bay Area, CA or Remote, with frequent travel
- Compensation: Competitive
- Employment: Permanent
- Visa Sponsorship: Will sponsor TN visa or equivalent. No H1B.