NPI Manufacturing Lead

Wellumio is a venture-backed medical device company on a mission to create universal access to diagnostic imaging. Magnetic resonance is the gold standard modality in medical imaging due to its exceptional soft tissue contrast. However, its accessibility is limited by high costs and the need to transport patients to scanners. At Wellumio, we are driven by a simple yet transformative idea: instead of bringing patients to the scanner, we bring the scanner to the patients, wherever it is needed. By providing point-of-care imaging, Wellumio enables healthcare professionals to deliver earlier diagnoses, faster treatments, and better outcomes. Our second-generation scanner, Axana, is 99% lighter than conventional MRI systems, making it the most portable head magnetic resonance imaging system in the global brain and neuroimaging market. The company's first target application is acute stroke, a leading cause of human mortality and disability. Currently, only 1.5% of patients receive treatment within the critical time window due to reliance on in-hospital imaging. Wellumio's point-of-care solution addresses this, making effective stroke treatment accessible wherever patients are. With stroke projected to cause 7.5 million deaths and cost $1 trillion annually by 2030, there is an urgent need for cost-effective technologies that can streamline care pathways for stroke and other neurological conditions where time is critical. Why should you be part of Wellumio's success story? To work with a talented and passionate team dedicated to positively impacting the medical device industry. To grow your skills and knowledge through ongoing training and development opportunities. To work in a dynamic environment that rewards creativity, innovation, hard work, and continuous improvement. At Wellumio we're challenging dominant models of clinical service delivery by fusing technology, design innovation, medical expertise, and systems-level thinking to create imaging solutions that put the needs of patients first. Position Overview The NPI Manufacturing Lead owns Wellumio's transition from R&D prototype to clinically deployable and eventually commercially manufacturable device. This role is responsible for the end-to-end new product introduction process — defining manufacturing processes, documenting work instructions, qualifying suppliers, and establishing the production system that sits behind Axana. What You’ll Do Working in partnership with relevant departments, you will: 1.NPI Process Ownership – Own the end-to-end NPI process for Axana: from engineering release to trial-ready build – Develop manufacturing process documentation: work instructions, assembly procedures, inspection plans, and build records – Define production flow, station layout, and material handling for the initial build programme – Establish acceptance criteria and inspection protocols for all manufactured assemblies – Identify, qualify, and manage the supplier base for manufactured components, sub-assemblies, and materials – Develop supplier quality agreements and incoming inspection plans – Work with the Production Technician on incoming goods inspection and non-conformance handling 3.Design-for-Manufacture Engagement – Partner with mechanical, electronics, and RF engineering teams to ensure designs are manufacturable – Drive DFM/DFA reviews early in the design cycle; flag issues before they reach tooling or production – Influence design decisions to reduce manufacturing cost, complexity, and risk 4.Quality System Integration – Develop manufacturing-related quality records aligned with ISO 13485 – Support QMS audit readiness for the manufacturing domain — processes must be auditable – Manage non-conformances, corrective actions, and deviations at the manufacturing level 5.Scale-Up Planning – Develop a manufacturing scale-up roadmap from feasibility study units to pivotal trial volume – Identify capital equipment needs, lead times, and make/buy decisions – Build manufacturing cost models to support financial planning and board reporting What You’ll Bring Experience & Qualifications Degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or equivalent 8+ years in NPI, manufacturing engineering, or production engineering — medical device or high-reliability hardware background strongly preferred Proven track record taking a product from R&D/prototype to repeatable production Familiarity with ISO 13485 manufacturing requirements and medical device design controls Project management experience focused on the NPI critical path, manufacturing scale-up roadmaps, and leading cross-functional process establishment projects (including documentation and QMS integration) Technical Capabilities Deep DFM/DFA expertise: can assess a design and identify manufacturing risk instinctively Process development: work instructions, control plans, and process FMEA Supplier management: qualification frameworks, incoming inspection, and quality agreements Understanding of IEC 60601-1 requirements relevant to manufacturing ERP or production management system experience preferred Skills & Behaviours Takes the critical path seriously: understands that clinical timelines have real patient consequences Structured and documentation-driven: leaves behind clear, maintainable records Builds trust with suppliers and internal teams through clarity and consistent follow-through Raises issues early and proposes solutions, not just problems Soft Skills Requirements Growth mindset and willingness to learn through coaching, feedback, and hands-on experience Strong attention to detail and commitment to high-quality work Takes ownership of tasks and follows through on commitments Collaborative team player who communicates openly and respectfully Adaptable and comfortable working in a fast-paced, evolving environment Curious, proactive, and motivated to continuously improve Professional, reliable, and committed to Wellumio's mission WHAT SUCCESS LOOKS LIKE (12-18) Axana trial units built to documented, repeatable processes on schedule — zero critical-path delays attributable to manufacturing Manufacturing process documentation is complete, current, and ready for QMS audit Supplier base is qualified with incoming inspection in place for all critical components QMS audit (manufacturing scope) evidence base is complete and submission-ready Scale-up plan is documented and validated against clinical trial volume requirements HOW TO APPLY If you're excited to be part of a new era of point-of-care brain imaging, we'd love to hear from you. Please submit a CV and brief cover note outlining relevant experience and why this mission matters to you. #J-18808-Ljbffr