СШАVice President, Operations | Aetherus Health
1 нед. назад
СШАSenior
regulatoryproduct deliveryengineeringquality managementmanufacturingsupply chain
Executive role managing non-commercial operations for a medical device startup including product delivery, engineering, regulatory, and supply chain with a focus on execution.
О компании
- Aetherus 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:
- Global headquarters in New Jersey
- Operating, clinical, and product development base in Pittsburgh
- Engineering and development with an external partner in Minneapolis
- Specialist partners used wherever they offer the best mix of capability, speed, quality, and cost
- 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
- NLC Health Ventures is a leading healthtech and biotech innovation platform based in Amsterdam, combining venture building and fund management across Europe and North America. With 40-45 employees, NLC manages four captive funds investing in ventures from pre-seed to Series B-C, and is fundraising for a fifth fund. The funds have a diverse LP base and are invested in over 70 companies. NLC values a collaborative, open, and impact-driven culture, where team members' ideas and contributions truly matter.
Обязанности
- We are looking for a disciplined medical device operator to own the full non-commercial path from product to patient: product delivery, engineering and software, regulatory, quality, manufacturing, supply chain, and launch readiness.
- This is a hands-on executive role, not a strategy or oversight role. You will turn agreed strategy into delivered outcomes, keep complex programs moving through the messy middle, and make decisions within agreed boundaries. Much of the specialist capability sits with external partners, so you will lead through influence, contracts and clear accountability rather than headcount. As Aetherus scales, operational functions will report into you.
- Your Role
Требования
- You are strongest in the middle of complex programs and you carry work through until it ships. We are looking for someone who:
- Values outcomes over activity and completion over presentation
- Surfaces bad news early, challenges hard before decisions, then executes fully once aligned
- Is structured and detail-aware without being bureaucratic or slow
- Leads through influence across people who do not report to them
- Is non-territorial and focused on patient outcomes
- 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)
Будет плюсом
- Software containing or connected medical devices
- Experience building an operating organization from an early stage
- Respiratory, DME, or health system experience
Условия
- Own the path to launch for a device that gives COPD patients relief when they need it most. A clear track to COO as scope and trust grow, and a high-contact partnership with the Founder & CEO
Другое
- Location: Pittsburgh, PA
- Reports to: Founder & CEO
- Start date: January 2027
- Employment: 0.6 FTE to start, scaling to full-time employment as financing closes
- Career path: Clear track to Chief Operating Officer
- Compensation: Salary + equity participation
- 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, not just the problem
- Run a lean operating cadence that gives the CEO and Board confidence without bureaucracy
- 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
- 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
- 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
- A commercial, business development or strategy-only role
- A project coordinator role that reports status while decisions stay with the CEO
- A pure engineering, regulatory, quality or manufacturing specialist role. This is an integrated operating leadership role.
- A large company role supported by internal departments