Senior Mechanical Engineer

Posted 4 Days Ago
Be an Early Applicant
Irvine, CA, USA
In-Office
135K-150K Annually
Senior level
Biotech
The Role
Design and commercialize electromechanical diagnostic systems from concept through production. Responsibilities include mechanical subsystem design, SolidWorks modeling, FEA, tolerance analysis, fixture and tooling development, design reviews, verification testing, documentation, supplier qualification, design transfer, and manufacturing support. The role collaborates across electrical, software, optical, quality, and manufacturing teams while mentoring junior engineers and ensuring compliance with regulated product development standards.
Summary Generated by Built In
About Us   

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.  

 
 
About the Role
 
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.
 
Team culture: 
- Positive 
- Proactive 
- Accountable  
- Team oriented 
- Continuous learner
- Great communicator  
- Build strong working relationships 
- Contribute to a productive team culture
 

What You Will Do

  • 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.

What You'll Need to Have

    • 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.
    • Preferred Qualifications
      • 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.

Interview Process  

Our interview processes my differ slightly from role-to-role; however, most of our interviews will follow a similar pattern: 

- Recruiter Interview  

- Hiring Manager interview  

- On-site Interview

- Decision    

We are an early-stage company and may change our interview process from time-to-time, but our hope is everyone who interviews with us has a positive experience, even if an offer isn’t presented.  

 
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  

 
Work - Life Balance Minded Time Off  

- 15 paid vacation days  

- 2-week paid winter break  

- 7 company paid holidays  

- 5 paid sick days 

 
A Work Culture Which Believes in Promoting from Within

- Wear lots of hats / accelerate your career growth! 

- We are a flat organization by design – lots of visibility!   

- Many of our current leaders started their career with Fluxergy!    

 
Salary Range: $135,000-150,000/yr
 
Additional Information

Fluxergy is an Equal Opportunity Employer and is committed to building an inclusive workplace. Qualified applicants will receive consideration for employment without regard to any protected characteristic under applicable federal, state, or local law.

If you require a reasonable accommodation during the application or interview process, please let us know at any point during the hiring process.

Fluxergy participates in E‑Verify. Employment eligibility will be verified after hire in accordance with federal law.

Fluxergy is committed to protecting your personal data. Please review our Privacy Policy.

Skills Required

  • Bachelor’s or master’s degree in Mechanical Engineering or a related discipline
  • At least 5 years of experience developing electromechanical products, preferably in medical devices or regulated industries
  • Strong proficiency with SolidWorks, including 3D modeling, mechanical drawings, and GD&T
  • Experience with electromechanical integration, PCBA collaboration, fixture and 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, collaboration, prioritization, and adaptability skills
  • Demonstrated accountability, initiative, and ability to mentor and develop others
  • 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
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The Company
HQ: Irvine, California
96 Employees
Year Founded: 2011

What We Do

Fluxergy was founded 10 years ago with a vision to democratize the world of laboratory testing, by making testing more accessible and affordable. Fluxergy’s platform technology enables us to understand our world and our health in ways that were never possible before. Fluxergy is developing a platform with multi-modal detection technologies which bring the variety of tests found in the central lab to the palm of your hand – This includes molecular testing like PCR, Immunochemistry and chemistry testing, and microscopy testing such as cytometry. Fluxergy’s platform vision is the detection of genes, proteins, small molecules, and cells with the same analyzer. The automated, sample-to-answer workflows can be customized for specific sample and testing methods.

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