Senior R&D Mechanical Engineer, Irvine

Senior R&D Mechanical Engineer

5 Days Old

Job Description
Catalyx is seeking a Sr. Mechanical Engineer, who 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. 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.

Job Description

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.

Requirements

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.

Why Join Catalyx?

At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone.

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Location:: Irvine

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