NPI Manufacturing Lead

Company Overview

Wellumio is a venture-backed medical device business focused on making diagnostic imaging accessible to everyone. Its mission is to move imaging closer to patients by delivering scanner technology at the point of care, rather than requiring patients to travel to a hospital scanner.

The company’s second-generation system, Axana, is designed for portability and is 99% lighter than conventional MRI systems, positioning it as a highly portable head magnetic resonance imaging platform for brain and neuroimaging use.

Wellumio’s initial clinical focus is acute stroke, where speed is critical and current reliance on in-hospital imaging means only 1.5% of patients are treated within the vital treatment window. By enabling imaging wherever patients are, the company aims to improve access to timely stroke care and support better outcomes for neurological conditions where rapid diagnosis matters.

The broader healthcare need is significant: stroke is projected to drive 7.5 million deaths and cost $1 trillion annually by 2030, increasing the demand for practical, cost-effective technologies that can improve care pathways.

Why join Wellumio? You’ll work with a passionate team committed to improving the medical device sector, develop your capabilities through ongoing training, and contribute in an environment that values creativity, innovation, hard work, and continuous improvement.

Wellumio blends technology, design thinking, medical expertise, and systems-level problem solving to create patient-first imaging solutions that challenge traditional clinical service models.

Position Overview

The NPI Manufacturing Lead is responsible for taking Axana from an R&D prototype through to a clinically deployable device and ultimately a product that can be manufactured at commercial scale. This role owns the full new product introduction process, including manufacturing process definition, work instruction development, supplier qualification, and creation of the production system supporting Axana.

Reporting to: CTO
Location: Wellington, New Zealand; on-site attendance is required
Employment Type: Permanent, full-time
Salary: NZ$110,000–130,000 per year

What You’ll Do

You will work closely with cross-functional teams to establish and scale the manufacturing process.

• Take full ownership of the NPI journey for Axana, starting at engineering release and continuing through to trial-ready builds.
• Create and maintain manufacturing documentation, including assembly instructions, work instructions, inspection plans, and build records.
• Set up the initial production flow, station arrangement, and materials movement for the first build programme.
• Define acceptance standards and inspection methods for all manufactured assemblies.
• Source, assess, and manage suppliers for components, sub-assemblies, and raw materials.
• Prepare supplier quality agreements and incoming inspection processes.
• Coordinate with the Production Technician on receiving inspection and handling non-conforming goods.
• Work alongside mechanical, electronics, and RF engineering teams to ensure designs can be built efficiently and reliably.
• Lead DFM/DFA reviews early in development to identify manufacturing issues before tooling or production.
• Help guide design choices that lower cost, simplify assembly, and reduce production risk.
• Develop manufacturing-related quality documentation aligned with ISO 13485.
• Support audit readiness for the manufacturing portion of the QMS, ensuring processes remain traceable and auditable.
• Manage manufacturing-level non-conformances, corrective actions, and deviations.
• Create a scale-up plan from feasibility units through to pivotal trial volumes.
• Identify equipment requirements, lead times, and make-versus-buy decisions.
• Build manufacturing cost models for financial planning and board reporting.

What You’ll Bring

The ideal candidate will have the background and capability to drive manufacturing readiness for a complex medical device.

• A degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a closely related discipline.
• At least 8 years of experience in NPI, manufacturing engineering, or production engineering; experience in medical devices or similarly high-reliability hardware is strongly preferred.
• A demonstrated history of moving products from prototype stage into repeatable production.
• Working knowledge of ISO 13485 manufacturing expectations and medical device design controls.
• Project management experience covering NPI critical path delivery, manufacturing scale-up planning, and cross-functional process implementation, including documentation and QMS integration.
• Strong DFM/DFA judgement and the ability to quickly spot manufacturing risks in a design.
• Capability in process development, including work instructions, control plans, and process FMEA.
• Experience with supplier qualification, incoming inspection, and quality agreement setup.
• Understanding of IEC 60601-1 requirements relevant to manufacturing.
• Exposure to ERP or production management systems is preferred.
• A structured, documentation-led working style with a focus on clear and maintainable records.
• Confidence in building trust with internal stakeholders and suppliers through transparency and follow-through.
• A proactive approach that surfaces issues early and brings practical solutions.
• Growth mindset, willingness to learn, strong attention to detail, ownership of work, and a collaborative communication style.
• Comfort working in a fast-moving environment and a genuine commitment to Wellumio’s mission.

What Success Looks Like

• Trial units for Axana are built on time using documented, repeatable processes, with no critical-path delays caused by manufacturing.
• Manufacturing documentation is complete, current, and ready for audit review.
• The supplier base is qualified and incoming inspection controls are in place for all critical components.
• The manufacturing audit evidence pack for the QMS is complete and ready for submission.
• The scale-up plan is documented and aligned with clinical trial volume requirements.

How to Apply

If you’re interested in helping shape the future of point-of-care brain imaging, send through your CV along with a short cover note that explains your relevant experience and what draws you to this mission.

Additional Information

This role is based in Wellington, New Zealand and requires on-site work. It is a permanent, full-time position reporting to the CTO. The salary range is NZ$110,000 to NZ$130,000 per annum.