Director - R&D Project Management Medical Device

Company:ASTRALX INC and NOVEXIS INC (holding company)

Employment type:Full-time, salary (exempt)

Pay range:$120,000–$170,000 per year + bonuses and equity

Department:Product Development

Reports to:Founder & CEO

Works closely with:Engineering partners, Clinical Affairs, the Chief Medical Officer

ASTRALX INC is a medical device company building a next-generation liposuction platform that unifies ultrasound-assisted (UAL) and power-assisted (PAL) liposuction with AI smart calibration in one ergonomic system. The company was co-founded by medtech operator Ewan Mohammed and Dr. Alfredo Hoyos, pioneer of High-Definition Liposculpture, and is preparing for launch alongside the ASTRALX INSTITUTE™, a global network of surgeon-led training centers.

NOVEXIS INC is the Delaware holding company, headquartered in Irvine, that builds and scales the group's medical device businesses. We're looking for the product leader who will take the ASTRALX platform from concept through FDA submission and commercial launch, then bring the same discipline to future devices across NOVEXIS.

This is an ownership role, not a support role. You'll lead the end-to-end development of the ASTRALX platform, working alongside our engineering partners, clinical advisors, and surgeon collaborators to bring it from concept to market. You'll own the program — its scope, timeline, quality, and outcome — and serve as the person the executive team relies on to move the product forward with rigor and momentum.

This role reports directly to the Founder & CEO.

• Product development lifecycle:Lead the full lifecycle from concept through design, prototyping, verification and validation, FDA 510(k) submission, and commercial launch.
• Design control and documentation:Own Design Control and the Design History File, including protocols, reports, traceability matrices, and design documentation, to FDA and ISO 13485 standards.
• Program management:Build and manage the program plan — scope, schedule, budget, resources, and critical path — keeping every work stream aligned with the company's funding milestones.
• Risk and problem-solving:Anticipate risks, bottlenecks, and gaps early, and drive them to resolution with sound engineering judgment.
• Cross-functional leadership:Coordinate external engineering partners, contract manufacturers, vendors, and internal stakeholders toward a unified product vision, integrating technical, clinical, and commercial requirements.
• Relationship management:Serve as a trusted partner to our clinical advisors and surgeon collaborators, translating their input into product decisions and maintaining those relationships with credibility.
• Reporting and stakeholder alignment:Provide clear, disciplined program reporting to executive leadership, the Board, and investors on progress, risk, and timeline.
• Intellectual property:Partner with counsel on IP diligence to ensure clean, defensible product development.
• Group portfolio:As ASTRALX advances, help NOVEXIS INC evaluate and plan future device programs across the group.

• Bachelor's degree in Mechanical Engineering or a closely related engineering discipline — a foundation grounded in materials and in the full arc from concept to production.
• Proven medical device product development experience, having brought at least one product from concept through FDA clearance or submission.
• Deep command of Design Control, Design History Files, and FDA and ISO 13485 requirements for medical devices.
• A demonstrated track record of driving development programs to commercialization on schedule and within budget.
• The presence and judgment to hold relationships with senior surgeons, investors, and external partners — a leader the executive team can trust…