Mechanical Engineer

SiPhox is embarking on an ambitious effort to develop and commercialize an at-home diagnostic platform with a large menu of multiplexed immunoassay applications. Our chip-based solution combines state-of-the-art biochemistry, photonics, electronics, and microfluidics to provide the power of large laboratory instruments in a portable device. We are growing our engineering team to make this happen.

The ideal candidate will have a history of developing instrumentation in the biotechnology/medical device space from ideation to large-scale manufacturing. The ideal candidate should have broad knowledge across mechanical design, microfluidics, liquid handling, and industrial automation tools. In office work is required for this position to enable testing with instrumentation development hardware. Workflow and team development is a large part of this role as we are scaling up our team and organization.

Key Responsibilities:

• Lead the design and development of mechanical components and systems for a groundbreaking at home blood testing platform
• Apply design control processes to ensure compliance with regulatory standards (FDA, ISO, etc.) throughout the product lifecycle
• Conduct Failure Modes and Effects Analysis (FMEA) to assess and mitigate risks in product design
• Implement Design for Manufacturability (DFM) principles to ensure efficient and cost-effective production
• Design for a variety of manufacturing methods, including CNC machining, injection molding, and sheet metal fabrication
• Collaborate closely with cross-functional teams (engineering, regulatory, assay development, manufacturing) to ensure seamless development and integration
• Drive design reviews with external design houses and manufacturing partners to refine and optimize designs

Required Qualifications:

• Bachelor's or Master’s degree in Mechanical Engineering or a related field
• 5+ years of experience in mechanical design, with a focus on instrumentation for biotech, medical devices, or related fields
• Proven experience with design controls and development processes for regulated products (e.g., FDA, ISO 13485)
• Hands-on experience with Failure Modes and Effects Analysis (FMEA) and risk management in product design
• Extensive knowledge of Design for Manufacturability (DFM) and experience designing for diverse manufacturing processes, including CNC machining, injection molding, and sheet metal
• Experience in managing design reviews with external partners and contract manufacturers
• Strong understanding of materials selection and mechanical testing methods
• Excellent problem-solving skills and attention to detail
• Strong communication and collaboration skills, with the ability to work across multiple teams

Preferred Qualifications:

• Bachelor’s or master’s degree in mechanical engineering or a related field
• Experience with CAD software (e.g., SolidWorks, OnShape)
• Familiarity with medical device regulations (e.g., 21 CFR Part 820, ISO 13485)
• Experience with rapid prototyping, including 3D printing and other rapid manufacturing techniques

Benefits

• Opportunity to work in a dynamic and fast-paced environment
• Health, Dental, Vision, and Life insurance
• Membership to Life Time Fitness ($280/month in value)

About SiPhox

SiPhox, is revolutionizing diagnostics through silicon photonics. Our devices 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.