Operations Lead – IVD / Medical Devices / Lateral Flow
📍 Wisconsin, USA
🧪 Manufacturing | NPI | Scale-Up | ISO13485
CY Partners are supporting an innovative diagnostics and medical device manufacturer in Wisconsin in the search for an experienced Operations Lead to oversee manufacturing operations and drive the successful transfer and scale-up of new products into production.
This is a hands-on leadership role sitting at the intersection of Operations, Quality, and R&D, ideal for candidates with experience in IVD, lateral flow assays, diagnostics, or regulated medical device manufacturing environments.
Key Responsibilities
- Lead day-to-day manufacturing operations across safety, quality, delivery, and cost targets
- Drive technology transfer and new product introduction (NPI) from R&D into manufacturing
- Support process scale-up, pilot builds, validation activities (IQ/OQ/PQ), and continuous improvement initiatives
- Ensure compliance with GMP, ISO13485, ISO9001, and FDA-regulated quality systems
- Develop and mentor production teams while improving operational efficiency and reducing waste
- Collaborate cross-functionally with Quality, Engineering, Supply Chain, and Technical teams
Ideal Background
- Experienced in medical devices, diagnostics, biotech, or lateral flow manufacturing
- Proven experience supporting technology transfer, process scale-up, or NPI projects
- Strong understanding of regulated manufacturing environments and quality systems
- Leadership experience within production or operations teams
- Lean / Six Sigma experience advantageous
This is an excellent opportunity to join a growing and purpose-driven organisation developing impactful healthcare technologies in a highly collaborative manufacturing environment.