Mechanical Engineer – Early Stage Product Development (Medical Devices)

StarFish Medical – Irvine, CA (On-Site)

Position Overview

StarFish 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 SolidWorks for early prototypes, assemblies, and evolving system architectures
• Maintain revision control of 3D models and drawings using SolidWorks 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 (SolidWorks) 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

Base salary may vary based on (but not limited to) work experience, education and/or training, critical skills, and/or business considerations.

Annual variable compensation: Target of 3 -10% of base salary, tied to goal achievement

Additional Compensation: Employees are eligible for a profit-sharing program

Benefits of working at StarFish Medical:

Becoming a part of a group of passionate individuals striving to make a meaningful impact, combined with:

• Make a meani