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Senior R&D Mechanical Engineer
FluxergyUnited Statesfull_timeVerifiedPosted 5 May 2025
💰 $145,000/yr($135,000/yr – $145,000/yr)
About the role
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
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 inje
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