Product Development Engineer - Blood Separation & ...

Position Overview:We are seeking a highly motivated and experienced Product Development Engineer with expertise in biomedical engineering and microfluidics, with a specific focus on blood-to-serum/plasma separation and human-centered design. The ideal candidate will have a minimum of 3 years of experience in developing biomedical products and optimizing user experience (UX) and usability/human factors (HF), particularly within blood sample collection and microfluidics systems.You will be responsible for designing and refining products that ensure a seamless and safe user experience for blood collection and separation processes. The role emphasizes working on the arm collector to streamline blood-to-serum/plasma separation, aiming to maximize both the performance of the device and the ease of use for non-specialist users, such as patients at home.Key Responsibilities:Lead the development of a diagnostic product focused on blood-to-serum/plasma separation using microfluidic systems, from concept to prototyping, testing, and manufacturing.Prioritize user experience, including ergonomics, safety, and ease of use, starting from the arm collector device.Collaborate with UX, human factors experts, and cross-functional teams (R&D, quality, and regulatory affairs) to ensure devices meet user needs, customer requirements, and regulatory compliance (ISO 13485, FDA).Design for Manufacturing (DFM) and Design for Assembly (DFA), focusing on usability and user-centered design to ensure scalable, user-friendly products.Conduct user testing and human factors analysis to validate the ease of use, comfort, and safety of devices in real-world scenarios.Lead the design and development of blood separation techniques that optimize efficiency while maintaining a seamless user experience.Work closely with regulatory teams to ensure products meet FDA usability standards and other relevant guidelines.Document the development process, create detailed technical documentation, and user guides with an emphasis on user training and clarity.Conduct failure mode and effects analysis (FMEA) with a focus on user impact and troubleshooting design issues that affect both performance and usability.Engage with external suppliers and manufacturers for component sourcing and fabrication.Qualifications:Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or a related field.Minimum of 3 years of experience in biomedical product development, focusing on microfluidics, blood separation, or diagnostics.Proven experience in microfluidic device design and user-centered design for medical devices, with a particular emphasis on blood separation processes.Strong understanding of human factors engineering and experience in usability testing for medical or diagnostic devices.Proficiency in CAD software (e.g., SolidWorks, Autodesk Fusion) and hands-on prototyping tools (e.g., 3D printing).Familiarity with ISO 13485, FDA usability standards, and other relevant medical device regulations.Excellent communication skills and experience working in cross-functional teams, especially with UX designers or HF engineers.Preferred Qualifications:Experience with blood collection systems, including arm collectors or similar devices, and their impact on usability.Knowledge of blood separation methods and common challenges in home diagnostics.Experience in bioassays or diagnostic testing applications with a focus on user experience and product usability.Benefits:Comprehensive benefits package, including LifeTime Fitness gym membership.Opportunities for professional growth and development.Work in a dynamic, innovative environment with cutting-edge technology.About SiPhox:SiPhox, supported by Y Combinator, Intel, and Khosla Ventures, is revolutionizing diagnostics through silicon photonics. Our in-vitro diagnostic (IVD) devices, powered by disposable silicon photonic chip sensors, deliver the capabilities of large laboratory instruments in a compact form. Our mission is to provide accurate, reliable, and accessible diagnostic tools that empower healthcare professionals and improve patient outcomes.

Created: 2025-02-19