The Company is seeking a Vice President of Operations to take on a hands-on executive role, owning the full non-commercial path from product to patient. This includes product delivery, engineering and software, regulatory, quality, manufacturing, supply chain, and launch readiness. The successful candidate will be responsible for building and driving the integrated critical path to US launch, leading product finalization, surfacing risks and delays, and running a lean operating cadence. The role also involves leading engineering and development partners, owning executive accountability for FDA 510(k) submission readiness, and ensuring an appropriate QMS and design control framework. As the company scales, the VP of Operations will be instrumental in building the operational team and will represent the company on the ground, including participation in an accelerator pathway. Applicants for the VP of Operations role at the company should have a strong background in medical devices or closely related regulated products, with at least 10 years' experience and a proven track record of leading cross-functional programs to completion. The ideal candidate will have hands-on experience with Class II devices, including direct 510(k) and commercial launch experience, and a strong working knowledge of design controls, V&V, and QMS. The role requires a leader who is structured, detail-aware, and values outcomes over activity, with the ability to lead through influence and a focus on patient outcomes. Experience in early-stage or resource-constrained environments is essential, and a background in large companies with evidence of personal ownership is also welcome. The candidate should be based in the Greater Pittsburgh area and have existing US work authorization.

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