Senior R&D Mechanical Engineer, Irvine

Senior R&D Mechanical Engineer

88 Days Old

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.

Our product: https://vimeo.com/176673475

About the Role

As a Sr. Mechanical Engineer, you will play a pivotal role in an expanding R&D team, applying your expertise in mechanical design to develop the next generation of microfluidic consumables for our multimodality in-vitro diagnostic system. You will thrive in a dynamic environment, balancing multiple projects with agility, embracing a fail-fast approach to accelerate learning and refinement. Your work will span both R&D labs and the production floor, collaborating across disciplines-including microfluidic and process engineers, assay development scientists, software, electrical, and mechanical engineers-to drive meaningful advancements in diagnostic testing.

If you're the kind of person who likes to learn new stuff, solve tough problems, and work with a bunch of smart, motivated people-we'd really like to meet you.

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

Lead the design and development of complex microfluidic consumables with multiple integrated components, including blisters, heaters, valves, and fluidic networks, from concept to launch while managing technical risks.
Make critical design decisions, assessing trade-offs, downstream risks, and feasibility to optimize performance, cost, and manufacturability.
Develop and execute Design of Experiments (DOE) and comprehensive test plans to validate functional performance, reliability, and scalability.
Utilize CAD software (SolidWorks) for detailed 3D modeling, engineering drawings, and tolerance analysis, supporting rapid prototyping through 3D printing, CNC machining, laser cutting, lamination, and injection molding.
Design for injection molding, over-molding, bonding, and precision molding, ensuring robust, high-quality, and scalable manufacturable parts.
Apply expertise in fluidic product design, including microfluidics, MEMS, and assay workflows (PCR, electrochemistry, cytometry, immunoassay).
Conduct failure analysis and implement design modifications to address performance issues, leveraging data-driven problem-solving.
Collaborate cross-functionally with Manufacturing, Platform, and Assay Development teams to optimize designs for usability and scalability.
Prepare and contribute to FDA 510(k) submissions, ensuring compliance and influencing product design decisions.
Mentor and guide junior engineers, fostering an innovative and collaborative work environment while managing multiple projects efficiently.

What You'll Need to Have

BS or MS in Mechanical Engineering, Plastics Engineering Technology, or a related field (MS preferred).
7+ years of industry experience or 5+ years with a Master's degree, specifically in developing and sustaining multi-component consumable Point-of-Care devices in the life sciences industry.
Proven experience successfully bringing medical devices through the FDA 510(k) process and preparing regulatory documentation.
Expertise in Design of Experiments (DOE) for optimizing product performance and reliability.
Proficiency in SolidWorks, GD&T, and CAD software for 3D modeling, design iteration, and tolerance analysis.
Strong understanding of the full Product Life Cycle, including design methodologies, validation processes, risk assessments, and implementation.
Extensive experience designing plastic parts and assemblies for manufacturing by injection molding, over-molding, bonding, lamination, laser cutting, and precision molding.
Ability to analyze design trade-offs and conduct feasibility analysis, evaluating options based on performance, cost, and manufacturability.
Expertise in fluidic product design, with knowledge of fluid dynamics, microfluidic systems, and MEMS technologies.
Strong problem-solving skills and the ability to work independently in a fast-paced, technically challenging environment.
Experience with data analysis tools (e.g., Matlab, Python, JMP) for decision-making and test platform development.

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

- 99% 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 - $145,000/yr

Additional Information

Fluxergy is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, marital status, age, disability, national or ethnic origin, military service status, citizenship, or other protected characteristic.

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Location:: Irvine

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