Head of Product Development & Operations

About Matregenix, Inc.

Matregenix is a rapidly expanding startup headquartered in Mission Viejo, CA, specializing in nanofiber technology. The company offers customizable nanofibrous materials primarily for biomedical and filtration sectors. Their cutting-edge electrospinning machinery and full-service contract development and manufacturing provide clients with comprehensive nanofiber solutions, driving innovation in the field.

Role Overview

This full-time position, based on-site in Mission Viejo, CA, reports directly to the CEO. The Director of Product Development & Programs will lead the biomedical product development portfolio, advancing nanofiber medical device programs from initial concepts to preclinical phases and regulatory submissions. The role includes managing federally funded studies (SBIR/STTR, DoD), coordinating with academic and CRO collaborators, ensuring milestone tracking, and generating necessary technical reports.

Key Responsibilities

• Oversee planning and execution of biomedical device development projects, including design inputs, testing protocols, and design history records.
• Manage preclinical and benchtop experiments tied to grants and contracts while monitoring budgets and timelines.
• Prepare and submit technical reports, milestone documents, and progress updates to government and commercial sponsors.
• Assist regulatory strategies and help prepare submissions for 510(k) and other pathways.
• Coordinate cross-departmentally with R&D, manufacturing, and quality assurance teams to maintain project schedules.
• Support business development initiatives, sales of electrospinning equipment, marketing efforts, and proposal writing.
• Collaborate closely with the CEO to align company priorities and translate strategic goals into actionable plans.

Candidate Qualifications

• Bachelor’s degree in engineering, materials science, biomedical engineering, life sciences, or related disciplines; advanced degrees preferred.
• Strong ownership mindset, proactive attitude, and the ability to quickly learn and work independently.
• Experience in project or program management within a fast-paced startup environment.
• Prior contribution to 510(k) regulatory submissions is highly valued.
• Knowledge of medical device development, design controls, ISO 13485 standards, and preclinical study management is advantageous.
• Experience working with federally funded projects such as SBIR/STTR or DoD contracts is beneficial.
• Familiarity with electrospinning, nanofiber technology, or biomaterials is a plus.
• Excellent communication skills and capability to collaborate across technical and commercial teams.

Additional Information

• This is an on-site position located in Mission Viejo, CA; remote or hybrid work options are not available.
• Candidates must have authorization to work in the United States; visa sponsorship will not be provided now or in the future.

Industry

Nanotechnology Research and Medical Devices