Product Development Engineer – Blood Separation & Human-Centered Design

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.