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