VP of Manufacturing Full Time NEW

The Role

VP of Manufacturing owns the path from validated assay to manufactured strip — plus the Chemistry, Manufacturing, and Controls (CMC) documentation for our FDA submission. This is a founding-team hire. You’ll build the manufacturing operation, quality system, and supply chain from scratch alongside our CTO and CEO.

What We’re Building

Metsulin is building the world’s first point-of-care biosensor strip that measures both insulin and glucose from a fingerstick. No lab. No venipuncture. No wait.

The strip is an electrochemical lateral flow assay on screen-printed carbon electrodes. It uses a plasma separation membrane to work directly with whole blood and delivers quantitative results in minutes.

Behind the strip is a Clinical Decision Support System (CDSS) that performs real-time metabolic phenotyping — identifying each patient’s insulin resistance pattern and guiding primary care physicians toward targeted therapy. The platform is designed for remote patient monitoring (RPM), turning insulin into a longitudinal clinical tool.

What You’ll Do

Design Transfer — Lead design transfer to CMOs. Qualify contract manufacturers. Run process validation (IQ/OQ/PQ).

Quality System — Build the QMS from scratch: SOPs, DHF, DMR, DHR, CAPA, supplier qualification, incoming inspection.

Chemistry, Manufacturing, and Controls — Author CMC sections for our De Novo FDA submission. Support Breakthrough Device Designation and Pre-Submission meetings.

Supply Chain — Source materials, negotiate contracts, manage multi-vendor supply chain, establish dual-source strategies.

Collaboration — Work with our CTO to translate assay parameters into manufacturable process windows.

What You Bring

Required

• 7+ years in IVD medical device manufacturing, with direct experience on point-of-care diagnostic strips
• At least one full design transfer from R&D to a contract manufacturer — you wrote the transfer protocol, qualified the CMO, and ran validation batches
• Working knowledge of FDA 21 CFR Part 820 (QSR) and ISO 13485:2016 — you’ve contributed to or authored CMC sections of an FDA submission (510(k), De Novo, or PMA)
• Experience managing a multi-vendor medical device supply chain: supplier qualification, incoming inspection, non-conformance management
• Comfortable building from scratch alongside founders — not inheriting an existing system
• Bachelor’s or Master’s in Industrial Engineering, Biomedical Engineering, Chemical Engineering, or a related field

Strongly Preferred

• Experience with lateral flow assay or electrochemical biosensor strip manufacturing
• Hands-on experience with whole blood-based diagnostic tests — plasma separation, hematocrit interference, sample handling from fingerstick
• De Novo classification experience — you know what FDA expects in a CMC package for a novel device
• Familiarity with screen-printed electrodes, membrane-based plasma separation, or microfluidic POC construction
• Has worked in or alongside a pre-revenue medtech startup — comfortable with ambiguity, speed, and limited resources
• Experience with electrodeposition, surface chemistry, or analytical method validation for biosensors