Mechanical Engineer – Drug Delivery Devices

• Mechanical Engineer – Drug Delivery Devices
  
• Location: San Francisco, CA
  
• Employment Type: Full-time | Early Hire Opportunity
  
• Salary: 120,000
  

Position Overview

We are seeking a highly motivated Mechanical Engineer to join as an early hire and help bring an innovative drug delivery device platform to life. This role will span the full product development lifecycle—from concept through clinical readiness. It is a hands-on position for someone who thrives in fast-paced environments, takes ownership, and wants to help shape a high-impact product from the ground up.

Key Responsibilities

• Lead the mechanical design of novel drug delivery devices.
  
• Rapidly prototype, build, and test functional prototypes.
  
• Develop and refine parts and assemblies with a strong focus on Design for Manufacturability (DFM).
  
• Collaborate with vendors to support scale-up and manufacturing.
  
• Design processes, jigs, and tooling for pilot and low-volume production.
  
• Perform Failure Modes and Effects Analyses (FMEA) and contribute to broader risk assessments.
  
• Support preparation of regulatory documentation and design history files.
  

Requirements

Qualifications

• Bachelor’s degree or higher in Mechanical Engineering, Bioengineering, or related field.
  
• Proven experience in mechanical design and fluid dynamics.
  
• Proficiency with rapid prototyping methods (3D printing, machining, etc.).
  
• Prior experience working in a fast-paced, high-autonomy environment.
  
• Strong problem-solving skills with a hands-on approach.
  

Bonus (Preferred but not required):

• Experience in the medical device development process and familiarity with regulatory standards