VP Operations - Launch-Ready Med Device Leader

CAREERS AT NLC; Pittsburgh (Allegheny County); On-site; USD 180,000 - 270,000; Part time

Job summary

Aetherus Health is seeking a disciplined medical device operator to own the full non-commercial path from product to patient in Pittsburgh. This hands-on executive role covers product delivery, engineering and software, regulatory, quality, manufacturing, supply chain and launch readiness.

You will lead engineering and development partners, drive FDA 510(k) submission readiness, and build an integrated plan to reach US launch targeted for Q3 2027.

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 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.
• Based in the Greater Pittsburgh area, with existing US work authorization (visa sponsorship is not available).

Responsibilities

• Own Product to Market Execution: build and drive the integrated path to US launch in Q3 2027 and ensure manufacturing readiness.
• Lead Engineering and Development Partners: govern day-to-day delivery with external partners and hold them to clear deliverables and budgets.
• Regulatory and Quality: own executive accountability for FDA 510(k) submission readiness and clearance, and ensure an integrated design controls framework.
• Manufacturing, Supply Chain and Launch: select initial manufacturing partner and manage supplier, inventory and logistics plans.
• Build the Company: co-own early hiring and decide which capabilities stay outsourced.
• What This Role Is Not: avoid being only strategy or purely specialist roles.

Skills

Regulatory leadership

Program management

Cross-functional collaboration

Contract manufacturing management

Quality systems knowledge

Job description

Aetherus Health is seeking a disciplined medical device operator to own the full non-commercial path from product to patient in Pittsburgh. This hands-on executive role covers product delivery, engineering and software, regulatory, quality, manufacturing, supply chain and launch readiness.

You will lead engineering and development partners, drive FDA 510(k) submission readiness, and build an integrated plan to reach US launch targeted for Q3 2027.