Mechanical Engineer – Early Stage Product Development; Medical Devices

Mechanical Engineer – Early Stage Product Development (Medical Devices)

Position Overview

Star Fish Medical partners with innovators to develop breakthrough medical technologies. Our Irvine team is looking for a mechanical engineer who excels in early‑stage product development, someone who enjoys transforming ambiguous ideas into functioning prototypes through rapid iteration, clever mechanisms, hands‑on experimentation, and thoughtful engineering.

If you thrive on concept ideation, feasibility testing, prototyping, and architecting systems from the ground up, this role is designed for you. You will collaborate closely with a multidisciplinary team to explore design options, evaluate technical feasibility, and develop first‑generation hardware that lays the foundation for subsequent product development phases.

Why You'll Love It Here

At the Irvine site, you'll join a small, high‑energy team that values ingenuity, curiosity, and practical problem solving. You'll work in a creative environment where your early‑stage engineering skills directly impact breakthrough medical technologies.

Why This Role Is Different

You Will Spend Most Of Your Time

• Generating concepts and architectures
• Building and iterating early prototypes
• Solving novel, open‑ended mechanical problems
• Running benchtop experiments to drive design decisions
• Exploring methods, mechanisms, and materials using proof‑of‑principle models

If you enjoy the front end of innovation, you'll feel at home here.

What You'll Do

• Define and refine mechanical requirements through technical investigation and early feasibility work
• Lead concept development, mechanism ideation, and architecture‑level design
• Build benchtop prototypes quickly using CNC machining, sheet metal, 3D printing, compression molding, laser cutting, and other creative fabrication approaches
• Conduct feasibility tests, characterize performance, and propose design directions based on experimental evidence
• Evaluate materials, mechanical approaches, and design trade‑offs early in the product lifecycle
• Communicate design intent through sketches, block diagrams, models, and quick CAD concepts
• Follow best practices to create robust 3D models and drawings in Solid Works for early prototypes, assemblies, and evolving system architectures
• Maintain revision control of 3D models and drawings using Solid Works PDM
• Collaborate with electrical, firmware, software, human factors, and industrial design teams during concept exploration and development
• Work with vendors to produce prototypes and custom components, and to evaluate manufacturability
• Transition successful early concepts into structured development for later‑stage refinement

What You Bring

• Bachelor's degree in Mechanical Engineering
• 5 to 8 years or more of hands‑on mechanical product development experience, including significant early‑stage work
• Strong proficiency in mechanism design, prototyping, and engineering fundamentals
• Demonstrated ability to solve open‑ended technical problems with incomplete information
• Excellent CAD skills (Solid Works) applied to conceptual and early‑stage design
• Breadth of experience with common manufacturing processes such as CNC machining, sheet metal, injection molding, etc. and experience designing parts to be made using these processes
• Comfortable communicating evolving design concepts to both technical and non‑technical audiences

Preferred Qualifications

• Experience working on complex electromechanical or mechatronic systems
• Hands‑on experimentation background (physics, systems modelling, benchtop testing)
• Exposure to regulated development (FDA, ISO 13485, ISO 9001, AS9100, etc.)
• Consulting experience or work on multiple varied product categories
• Experience with FEA for feasibility studies (structural, thermal, or fluid)

Salary

Base Salary: USD 110,000 – 160,000 annually
Annual variable compensation:
Target of 3 – 10% of base salary, tied to goal achievement
Employees are eligible for a profit‑sharing program

Benefits Of Working At Star Fish Medical

• Make a meaningful impact through life‑changing medical technologies
• Excellent benefits package for you and your family
• Profit‑sharing program
• Monthly all‑hands meetings and an open communication…