Mechanical or Biomedical Engineer - Product Design & Development
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About this role
About Us
We are an early-stage company developing disruptive medical technologies that challenge industry norms and dramatically reduce cost and complexity. Our small, hands-on team designs, builds, and validates next-generation medical devices entirely in-house from concept through FDA submission.
If you are motivated by hard problems, rapid iteration, and real-world impact, this is the kind of place where your work will matter every day.
The Opportunity
We have openings for Mechanical or Biomedical Engineers who are either recent graduates or have up to five years of professional experience. You will help design and develop a new Class II medical device from the ground up and be involved in every part of the process, including CAD modeling, prototyping, system integration, and verification and validation (V&V).
What You Will Do
- Design and model mechanical subsystems and assemblies using Autodesk Inventor
- Build and test prototypes for airflow, pressure, vibration, and structural performance
- Support DFM, BOM creation, and documentation under FDA design control
- Participate in bench and environmental testing for verification and validation
- Collaborate with electrical, firmware, and manufacturing teams to integrate systems
- Contribute to risk analysis, labeling, and regulatory documentation
Requirements
What We Are Looking For
- B.S. or M.S. in Mechanical or Biomedical Engineering
- Strong fundamentals in fluid dynamics, pressure systems, and mechanical design
- Hands-on experience with prototyping or lab testing
- Curious, adaptable, and motivated to learn in a fast-paced, collaborative environment
Preferred Experience
- Up to five years of experience in product design or medical device development
- Familiarity with ISO 13485, IEC 60601, or FDA 510(k) processes
- Experience in machining, additive manufacturing, or test fixture design
Benefits
What We Offer
- Competitive salary and equity opportunity
- Health insurance stipend (QSEHRA) and 401(k)
- Paid vacation and holidays
- A front row seat in a fast-growing, mission-driven medtech startup
Company
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