What are the responsibilities and job description for the Product Development Engineer – Blood Separation & Human-Centered Design position at SiPhox Health?
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 :
Preferred Qualifications :
Benefits :
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.