Vice President, Operations | Aetherus Health

Pittsburgh, Pennslyvania. Posted a month ago

The role

This person will own the full non-commercial path from product to patient, including product delivery, engineering, software, regulatory, quality, manufacturing, and supply chain. They will lead through influence to drive the integrated critical path to US launch.

What you will do

Build and drive the integrated critical path to US launch in Q3 2027
Lead product finalization across hardware and software
Surface risks and delays early with recommendations
Run a lean operating cadence
Govern day-to-day delivery across engineering, software and product development partners
Own executive accountability for FDA 510(k) submission readiness and clearance
Ensure an appropriate QMS and design control framework
Select and onboard the initial manufacturing partner
Own the supplier, materials, inventory, logistics and fulfillment plan
Co-own early hiring and progressively lead operations hiring

Required qualifications

10+ years in medical devices or closely related regulated products, with growing operating accountability
Hands-on experience taking a Class II device toward or through FDA clearance
Experience managing contract manufacturers, suppliers and technology transfer
Strong working knowledge of design controls, V&V and QMS
Track record leading cross-functional programs to completion with incomplete information
Early-stage or resource-constrained experience
Based in the Greater Pittsburgh area
Existing US work authorization

Nice to have

Direct 510(k) and commercial launch experience
Large company backgrounds with clear evidence of personal ownership
Software containing or connected medical devices
Experience building an operating organization from an early stage
Respiratory, DME, or health system experience

Benefits

Clear track to COO as scope and trust grow
High-contact partnership with the Founder & CEO

Before you apply

Visa sponsorship is not available

About the company

Aetherus is an early-stage medical device company developing a pocket-sized positive pressure device for breathlessness relief. NLC Health Ventures is a healthtech and biotech innovation platform based in Amsterdam.