Vice President, Operations | Aetherus Health

CAREERS AT NLC•Pittsburgh, PA

11d•Onsite

About The Position

Aetherus Health is an early-stage medical device company developing a pocket-sized positive pressure device that gives patients rapid, drug-free relief from breathlessness while passively capturing physiologic data during treatment. The company is pursuing FDA 510(k) clearance for Lung Expansion Therapy, with COPD as the launch market and future opportunities in perioperative care and heart failure. The target is US commercial launch in Q3 2027. Aetherus runs a deliberately lean model with a global headquarters in New Jersey, an operating, clinical, and product development base in Pittsburgh, and engineering and development with an external partner in Minneapolis. Specialist partners are used wherever they offer the best mix of capability, speed, quality, and cost. This is a hands-on executive role focused on owning the full non-commercial path from product to patient, including product delivery, engineering and software, regulatory, quality, manufacturing, supply chain, and launch readiness. The role involves turning strategy into delivered outcomes, managing complex programs, and making decisions within agreed boundaries. The individual will lead through influence, contracts, and clear accountability, with operational functions reporting to them as the company scales.

Requirements

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; direct 510(k) and commercial launch experience strongly preferred
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; large company backgrounds welcome with clear evidence of personal ownership
Based in the Greater Pittsburgh area, with existing US work authorization (visa sponsorship is not available)

Nice To Haves

Software containing or connected medical devices
Experience building an operating organization from an early stage
Respiratory, DME, or health system experience

Responsibilities

Own Product to Market Execution
Build and drive the integrated critical path to US launch in Q3 2027
Lead product finalization across hardware and software: design freeze, V&V, submission readiness and manufacturing readiness
Surface risks and delays early, and bring options and a recommendation
Run a lean operating cadence that gives the CEO and Board confidence without bureaucracy
Lead Engineering and Development Partners
Govern day-to-day delivery across engineering, software and product development partners
Be technically credible enough to challenge assumptions and make sound operating calls
Hold partners to clear deliverables, timelines, quality standards and budgets
Regulatory and Quality
Own executive accountability for FDA 510(k) submission readiness and clearance
Keep regulatory work integrated with product, software, V&V and manufacturing plans
Ensure an appropriate QMS and design control framework as the team and supplier network grow
Manufacturing, Supply Chain and Launch
Select and onboard the initial manufacturing partner, including technology transfer and production readiness
Own the supplier, materials, inventory, logistics and fulfillment plan
Track COGS, supplier risk, capacity and lead times, and drive cost and manufacturability improvements
Build the Company
Co-own early hiring and progressively lead operations hiring
Decide with the CEO which capabilities stay outsourced and which move in-house
Represent Aetherus on the ground in Pittsburgh, including regular on-site participation in an accelerator pathway during the first half of 2027
Support clinical studies and health system pilots where operational integration is needed