Senior Mechanical Engineer

Fluxergy • Irvine, CA

20d

About The Position

Fluxergy is a rapidly growing in vitro diagnostics company innovating on the cutting-edge of laboratory testing. We’re developing the first and only multi-modal point-of-care platform that enables molecular, clinical chemistry, immunoassay, and hematology testing on the same system. Our platform spans many markets including the clinical, veterinary, and food safety industries. We are seeking self-motivated problem solvers who are excited to help decentralize traditional laboratory infrastructure. At the core of our company’s identity is a strong foundation in engineering. We take great pride in our commitment to critical thinking and pragmatic problem-solving through a modular and systemic perspective. We hold the conviction that transparent communication, coupled with the flexibility to adjust to evolving scenarios and the willingness to venture beyond familiar territories, is crucial to both our success and yours. As a Senior Mechanical Engineer, you will help develop and commercialize next-generation diagnostic systems by designing robust electromechanical solutions from concept through production. Working closely with electrical, software, manufacturing, and systems teams, you will contribute hands-on technical expertise while helping drive product quality, reliability, and manufacturability. This role is ideal for an engineer who enjoys solving complex technical challenges, collaborating across disciplines, and mentoring others in a fast-paced, regulated environment.

Requirements

• B.S. or M.S. in Mechanical Engineering or a related discipline.
• 5+ years of experience developing electromechanical products, preferably in medical devices or other regulated industries.
• Strong proficiency in SolidWorks, including 3D modeling, mechanical drawings, and GD&T.
• Experience with electro-mechanical integration, PCBA collaboration, fixture/tooling design, and prototyping.
• Knowledge of injection molding, DFM/DFA principles, and manufacturing processes.
• Experience performing FEA, tolerance analysis, and reliability testing.
• Familiarity with ISO 13485, FDA Quality System Regulations, IEC 60601, or similar regulated product development standards.
• Strong communication, problem-solving, and collaboration skills, with the ability to manage multiple priorities and adapt in a dynamic environment.
• Demonstrated accountability, initiative, and a passion for mentoring and developing others.

Nice To Haves

• Medical device, diagnostic instrument, or life sciences industry experience.
• Experience with optical systems, filters, imaging components, or sensor integration.
• SolidWorks Professional Certification, GD&T Certification, or Six Sigma certification.

Responsibilities

• Design and develop mechanical subsystems, assemblies, and components using SolidWorks, from concept through design transfer and production.
• Collaborate with electrical, software, and manufacturing teams to integrate mechanical, electronic, and optical systems into reliable products.
• Design and validate fixtures, tooling, and test equipment to support development, manufacturing, and quality objectives.
• Perform engineering analyses, including FEA, tolerance stack-ups, and reliability assessments, to optimize performance and mitigate risk.
• Lead design reviews, DFM/DFA activities, verification testing, and troubleshooting efforts to improve product quality and manufacturability.
• Author and maintain engineering documentation, subsystem requirements, and design history records in compliance with regulated development processes.
• Partner with suppliers and manufacturing teams to support component qualification, new product introductions, and design transfer activities.
• Mentor junior engineers and contribute to continuous improvement of engineering processes, tools, and best practices.

Benefits

• Excellent Medical/Dental Benefits - 95% medical benefit premiums paid by Fluxergy and covers employee, partner, and dependents
• 100% dental and vision premiums paid for employee, partner, and dependents
• 100% Life Insurance premiums paid for the employee
• 15 paid vacation days
• 2-week paid winter break
• 7 company paid holidays
• 5 paid sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Senior