Senior Project Engineer

4 days ago

San Antonio, Texas, United States KYDA Partners Ltd Full time $120,000 - $180,000 per year

Join a dynamic and fast-growing team dedicated to advancing life-changing medical technologies. We're seeking a
Senior Project Engineer
with a strong background in
product development, project leadership
, and
medical devices
—ideally with exposure to
allograft-based solutions
.

This role offers the opportunity to lead end-to-end product development efforts, from concept through commercialization, while working cross-functionally across engineering, QA, regulatory, and operations.

What You'll Do

  • Lead product development projects from concept to launch, driving timelines, budgets, and execution.
  • Design devices and accessories using CAD and FEA; ensure manufacturability and regulatory compliance.
  • Develop and execute validation protocols; support 510(k) and labeling submissions.
  • Mentor junior engineers and collaborate across teams to deliver high-quality, compliant solutions.
  • Execute experiments, analyze data, and support tissue processing and technology transfer efforts.

What You Bring

  • Bachelor's degree in Biomedical Engineering, Tissue Engineering, Mechanical Engineering, or related field (required)
  • 5–6 years of experience in product development (required)
  • 4+ years of experience in project management (required)
  • Proficiency in mechanical design and 3D modeling using CAD software (required)
  • Experience in manufacturing process design (required)
  • Working knowledge of design control processes (required)
  • Experience with allografts and/or medical devices (preferred)
  • Familiarity with FDA 21 CFR 1271, FDA 21 CFR 820, AATB, ISO standards, CGTP/cGMP, and other relevant regulations
  • Experience with process, equipment, and sterilization validations
  • Strong understanding of DFM principles, risk management (e.g., FMEA), and validation protocols
  • Excellent written and verbal communication, technical writing, and cross-functional collaboration skills
  • Ability to manage multiple projects in a fast-paced environment

Why Join Us?

This is a high-impact opportunity to innovate in a mission-driven environment and contribute to meaningful medical advancements. You'll gain exposure to cutting-edge product development and work alongside a collaborative, expert team.

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