- 경험
- 어느
- 샐러리
- —
- 채용 공고
- 1
- 게시됨
- 8시간 전
- 작업 모드
- 사무실에서
- 교육
- Bachelor's degree (engineering, materials science, biomedical engineering, life sciences, or related)
- 적임
- Applicants must be authorized to work in the United States; visa sponsorship is not available now or in the future.
- 재개하다
- 신청 시 필수 사항
당신이 일하게 될 곳
직무 설명
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