Operations Lead for Medical Device Launch: Path to COO

NLC Health Ventures

Pittsburgh (Allegheny County)

On-site

USD 180,000 - 280,000

Full time

3 days ago

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Benefits offered by this job

equity participation

Job summary

Aetherus Health in Pittsburgh is seeking an experienced operating leader to own the full non-commercial path from product to patient. You will drive product delivery, engineering and software, regulatory, quality, manufacturing, supply chain, and launch readiness in a hands-on executive role.

You will lead engineering and development partners, surface risks with options, and run a lean operating cadence to support the CEO and Board.

Qualifications

10+ years in medical devices or closely related regulated products
Hands-on experience taking a Class II device toward or through FDA clearance; direct 510(k) and commercial launch experience 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 evidence of ownership

Responsibilities

Own Product to Market Execution and build the integrated critical path to US launch in 2027
Lead product finalization across hardware and software; ensure design freeze, V&V, submission readiness and manufacturing readiness
Surface risks early and provide options and recommendations
Govern day-to-day delivery across engineering, software and product development partners
Own executive accountability for FDA 510(k) submission readiness and clearance
Select and onboard the initial manufacturing partner and manage supply chain and logistics
Represent Aetherus on the ground in Pittsburgh and support clinical studies as needed