Head of Product Development & Operations

Company Description

Matregenix is a fast-growing startup company specialized in nanofiber technologies, headquartered in Mission Viejo, CA. We specialize in highly customizable nanofibrous materials for a diverse range of applications, with a focus on biomedical and filtration fields. Our state-of-the-art electrospinning machines and comprehensive contract development and manufacturing services set us apart as a one-stop-shop for nanofiber solutions. We are shaping the future of nanofiber technology through cutting-edge platforms and innovation.

Role Description

This is a full-time on-site role for a Director of Product Development & Programs, based in Mission Viejo, CA, reporting directly to the CEO.

The Director of Product Development & Programs will own the execution of our biomedical product development portfolio — taking nanofiber-based medical device programs from concept through preclinical studies and toward regulatory submission. This includes planning and managing studies conducted under federal grants and contracts (SBIR/STTR, DoD), coordinating with academic and CRO partners, tracking deliverables and milestones, and preparing technical reports and documentation required by our funding agencies.

Because we are a small and fast-moving team, this role is intentionally broad. As bandwidth allows, the person in this role will also contribute to business development, support sales of our ElectroSpinTek electrospinning equipment line, assist with marketing and proposal writing, and take on whatever else moves the company forward. Everyone here wears multiple hats, and we're looking for someone who sees that as an opportunity rather than a burden.

Day-to-day responsibilities include:

• Leading planning and execution of biomedical product development programs, including design inputs, testing protocols, and design history documentation
• Managing preclinical and benchtop studies tied to grants and contracts, including timelines, budgets, external partners, and data review
• Preparing technical reports, milestone deliverables, and progress updates for government and commercial sponsors
• Supporting regulatory strategy and preparation of submissions (510(k) and related pathways)
• Coordinating cross-functionally with R&D, manufacturing, and quality to keep programs on schedule
• Contributing to business development, equipment sales support, marketing, and proposal development as needed
• Working side by side with the CEO on company priorities and helping translate strategy into execution

Qualifications

• Bachelor's degree required (engineering, materials science, biomedical engineering, life sciences, or related field); advanced degree a plus
• Strong attitude, ownership mentality, and a demonstrated ability to learn quickly and operate with limited direction — this matters more to us than any single line on a resume
• Proactive, organized, and comfortable leading projects and people in a fast-paced startup environment
• Project or program management experience is strongly preferred
• Prior experience contributing to 510(k) submissions is a significant plus
• Familiarity with medical device development, design controls, ISO 13485, or preclinical study management is a plus
• Experience with federally funded programs (SBIR/STTR, DoD contracts) is a plus
• Experience with electrospinning, nanofibers, or biomaterials is a plus
• Excellent written and verbal communication skills
• Ability to collaborate effectively across technical and commercial teams

Additional Requirements

• This is an on-site role in Mission Viejo, CA. Remote and hybrid arrangements are not available.
• Applicants must be authorized to work in the United States. We are not able to provide visa sponsorship now or in the future.

Industry

• Nanotechnology Research / Medical Device

Employment Type Full-time