Senior R&D Mechanical Engineer

Job DescriptionJob DescriptionCatalyx 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 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
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• 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.
  
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• Make critical design decisions, assessing trade-offs, downstream risks, and feasibility to optimize performance, cost, and manufacturability.
  
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• Develop and execute Design of Experiments (DOE) and comprehensive test plans to validate functional performance, reliability, and scalability.
  
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• 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.
  
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• Design for injection molding, over-molding, bonding, and precision molding, ensuring robust, high-quality, and scalable manufacturable parts.
  
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• Apply expertise in fluidic product design, including microfluidics, MEMS, and assay workflows (PCR, electrochemistry, cytometry, immunoassay).
  
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• Conduct failure analysis and implement design modifications to address performance issues, leveraging data-driven problem-solving.
  
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• Collaborate cross-functionally with Manufacturing, Platform, and Assay Development teams to optimize designs for usability and scalability.
  
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• Prepare and contribute to FDA 510(k) submissions, ensuring compliance and influencing product design decisions.
  
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• Mentor and guide junior engineers, fostering an innovative and collaborative work environment while managing multiple projects efficiently.
  
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Requirementsn

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• BS or MS in Mechanical Engineering, Plastics Engineering Technology, or a related field (MS ).
  
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• 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.
  
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• Proven experience successfully bringing medical devices through the FDA 510(k) process and preparing regulatory documentation.
  
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• Expertise in Design of Experiments (DOE) for optimizing product performance and reliability.
  
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• Proficiency in SolidWorks, GD&T, and CAD software for 3D modeling, design iteration, and tolerance analysis.
  
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• Strong understanding of the full Product Life Cycle, including design methodologies, validation processes, risk assessments, and implementation.
  
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• Extensive experience designing plastic parts and assemblies for manufacturing by injection molding, over-molding, bonding, lamination, laser cutting, and precision molding.
  
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• Ability to analyze design trade-offs and conduct feasibility analysis, evaluating options based on performance, cost, and manufacturability.
  
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• Expertise in fluidic product design, with knowledge of fluid dynamics, microfluidic systems, and MEMS technologies.
  
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• Strong problem-solving skills and the ability to work independently in a fast-paced, technically challenging environment.
  
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• Experience with data analysis tools (e.g., Matlab, Python, JMP) for decision-making and test platform development.
  
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Why Join Catalyx? n

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 , , , (including , , and ), , , , 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.