NPI Manufacturing Lead

About the role

Wellumio is seeking an NPI Manufacturing Lead to drive the transition of its portable MRI system, Axana, from prototype to a clinically‑ready, commercially manufacturable product. You will own the end‑to‑end new product introduction (NPI) process, ensuring that manufacturing is robust, repeatable, and compliant with medical‑device standards.

Key responsibilities

• Lead the full NPI lifecycle for Axana, from engineering release to trial‑ready build.
• Create and maintain manufacturing documentation, including work instructions, assembly procedures, inspection plans, and build records.
• Design production flow, station layout, and material‑handling solutions for the initial build program.
• Define acceptance criteria and inspection protocols for all manufactured assemblies.
• Identify, qualify, and manage suppliers, aligning procurement activities with NPI goals.
• Collaborate with R&D, quality, regulatory, and supply‑chain teams to ensure seamless hand‑off.

Required profile

• Proven experience leading NPI projects in a regulated, high‑tech environment.
• Strong cross‑functional collaboration skills and ability to work with diverse engineering and quality teams.
• Understanding of medical‑device manufacturing standards (e.g., ISO 13485).

Required skills

• New Product Introduction (NPI) process management
• Manufacturing process documentation
• Supplier qualification
• Production flow and station layout design
• Inspection protocol development

What we offer

• Opportunity to shape a breakthrough medical‑device technology.
• Access to continuous training and professional development.
• Dynamic, innovation‑focused environment that rewards creativity and hard work.