Lead Biomedical Engineer

We are a Houston-based orthopedic medical device company founded by a board-certified orthopedic surgeon with a singular mission: to deliver innovative, high-quality orthopedic products at a meaningfully lower cost than existing market alternatives. Our products are novel, patent-pending, and represent genuinely differentiated solutions — not incremental improvements — to challenges that currently lack adequate answers in the marketplace.

We are a small, entrepreneurial team where every individual has direct impact on product direction, patient outcomes, and company growth. We are looking for a mission-driven engineer who wants to build something that matters.

We are seeking an experienced and entrepreneurially minded Lead Engineer to take ownership of our engineering function. This individual will serve as the senior technical voice of the company, leading a small team of engineers and driving our product development pipeline from concept through regulatory submission and commercialization.

This is a rare opportunity for an engineer who wants to operate at the intersection of clinical insight and mechanical innovation — working directly alongside the company's founder, a practicing orthopedic surgeon, to solve real problems affecting real patients.

• Lead end-to-end product development for novel orthopedic devices, from concept and design through prototyping, testing, and design freeze
• Manage and mentor a small engineering team, setting technical direction and maintaining accountability for deliverables
• Conduct and oversee biomechanical analysis, finite element modeling, cadaveric and bench testing as required
• Collaborate directly with the founder/surgeon to translate clinical needs into device specifications
• Develop and maintain design history files (DHF), risk management documentation, and other regulatory records in compliance with FDA 21 CFR Part 820 and ISO 13485
• Support 510(k) and/or PMA submission activities in coordination with regulatory affairs partners
• Manage relationships with contract manufacturers, material suppliers, and testing laboratories
• Drive cost-conscious design decisions consistent with the company's mission of affordability
• Contribute to IP development and patent strategy in collaboration with legal counsel

• B.S., M.S., or Ph.D. in Biomedical Engineering, Mechanical Engineering, Biomechanics, or a closely related field
• 5+ years of hands-on experience in medical device product development, preferably in orthopedics, spine, or musculoskeletal devices
• Demonstrated ability to lead a technical team and manage multiple concurrent development projects
• Working knowledge of FDA design controls, ISO 13485, and medical device regulatory pathways
• Proficiency in 3D CAD (Solid Works, CATIA, or equivalent) and engineering analysis tools
• Strong mechanical intuition and hands-on prototyping ability

• Ph.D. in Biomechanics or Biomedical Engineering
• Experience with implantable orthopedic hardware (joint reconstruction, trauma fixation, soft tissue repair, or similar)
• Familiarity with ASTM and ISO test standards for orthopedic devices
• Experience working in a startup or early-stage medical device environment
• History of contributing to patent applications or IP disclosures

Beyond credentials, we are looking for a specific kind of person:

• Entrepreneurial spirit — someone who thrives with autonomy and takes genuine ownership of outcomes
• Innovative thinking — someone who questions assumptions and finds elegant solutions to hard problems
• Practical creativity — someone equally comfortable sketching ideas on a whiteboard and machining a prototype
• Mission alignment — someone motivated by improving patient care and reducing the cost burden of orthopedic treatment
• Collaborative character — someone who communicates openly, respects the clinical perspective, and builds trust with teammates

Compensation will be commensurate with experience and is competitive within the early-stage medical device sector. The package may include:

• Base salary range commensurate with experience
• Performance-based bonus potential
• Equity / profit-sharing participation
• Flexible work arrangements considered for the right candidate

Houston, Texas. Candidates based in or willing to relocate to the Houston area are strongly preferred. Houston is home to the Texas Medical Center — the largest medical complex in the world — and offers an unparalleled environment for careers in medical innovation.