Technical Operations Lead – Medical Diagnostics / IVD
Location: Wisconsin
Salary: Competitive + benefits
CY Partners are recruiting for a Technical Operations Lead to join an innovative and fast-growing medical diagnostics company operating within the IVD space. This is a pivotal role where you will take ownership of technical operations, supporting the development, scale-up, and regulatory readiness of cutting-edge diagnostic products.
This position offers a unique opportunity to build and shape laboratory and operational capabilities from the ground up, working at the intersection of science, engineering, and quality.
The Role
As Technical Operations Lead, you will be responsible for establishing and leading all technical operations activities. You will drive assay development through to validation and play a central role in transitioning products from R&D into a regulated manufacturing environment.
Key responsibilities include:
- Leading and developing the Technical Operations function
- Overseeing assay development and optimization for IVD applications
- Managing technology transfer from R&D into production environments
- Leading the design, build, and fit-out of laboratory facilities
- Driving the implementation and achievement of ISO certification (e.g., ISO 13485)
- Establishing and executing IQ/OQ/PQ (Installation, Operational, and Performance Qualification) protocols
- Leading validation activities to ensure compliance with regulatory requirements
- Collaborating cross-functionally with R&D, Quality, and Regulatory teams
- Ensuring all processes meet the standards required for medical diagnostics and IVD products
Your Background
We are looking for a technically strong and hands-on leader with experience in regulated diagnostics environments.
You will ideally have:
- A degree (or equivalent experience) in a relevant scientific discipline (e.g., Life Sciences, Biochemistry, Biomedical Science)
- Proven experience in IVD or medical diagnostics
- Experience with Lateral Flow is highly desirable
- Strong background in assay development and validation
- Experience with Tech Transfer and scaling processes into production
- Demonstrated experience working towards or maintaining ISO 13485 certification
- Hands-on experience with IQ/OQ/PQ and validation frameworks
- Experience setting up or expanding laboratory facilities is highly desirable
- Strong leadership and project management skills
Why Apply?
- Opportunity to play a key role in scaling a cutting-edge diagnostics company
- Influence the design and build of technical and laboratory infrastructure
- Work in a highly collaborative, innovation-driven environment
- Competitive salary and benefits package
If you are a driven Technical Operations professional looking to make a real impact in the medical diagnostics space, we would love to hear from you.
Apply now or contact CY Partners for more information.