Job Description

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.

This role

We are seeking a motivated Senior Mechanical Design Engineer to design our next IVD device for use in the home, working within a diverse team of technologists and scientists, to have an impact on future customers. They are passionate about using cutting edge techniques, creating the best possible overall solution and enjoy creative problem solving.

Responsibilities

• Develop mechanical designs for medical and diagnostic devices, ensuring functionality, reliability, and manufacturability.
• Design parts and assemblies optimized for high-volume injection molding and automated assembly methods.
• Apply rapid prototyping techniques to accelerate product development and iteration.
• Plan and execute engineering tests to validate designs and improve performance.
• Create detailed design specifications , including 3D and 2D MCAD models following ASME Y14.5 or ISO 8015 standards.
• Collaborate with cross-functional teams , including engineers and scientists, to solve complex technical challenges.
• Conduct root cause analysis and implement design or process changes to enhance product quality and performance.
• Maintain strong organizational skills and adaptability in a dynamic, fast-paced environment.
• Contribute to system design , system and sub-system requirements and verification plans

Qualifications

• 5+ years experience developing medical and/or diagnostic devices as a mechanical engineer
• Expertise in design for high-volume manufacturing processes, including injection molding and automated assembly
• Proficient in MCAD (Solidworks and/or Onshape preferred)

Preferred Qualifications:

• Experience developing diagnostic systems for home use
• Experience with liquid handling systems and microfluidics
• Working under design controls (ISO 13485) and contributing to systems designed for FDA approval, especially designing and executive verification testing
• Experience scaling products from pilot production to high volume manufacture
• Creating and contributing to risk management (e.g. dFMEA)
• Strong supplier management skills, including identifying and establishing relationships with key vendors, in North America and Asia

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