Lead Product Designer/Product Architect (COE)

Role Overview: Lead the end-to-end product development of advanced diagnostic devices that enables rapid, accurate, and user-friendly sample-to-result testing across a wide spectrum of clinical specimens. Your role focuses on addressing the unique challenges of low-resource and decentralized settings, demanding a balance of technical complexity, user ergonomics, regulatory compliance, and cost constraints to deliver a manufacturable solution that makes a meaningful clinical impact. Key Responsibilities: - Architect integrated systems combining mechanics, optics, microfluidics, electronics, and software into compact, robust point-of-care diagnostic devices. - Lead iterative design convergence through simulation, prototyping, testing, and structured design reviews. - Diagnose and resolve complex failures such as fluid leaks, optical misalignment, and cross-functional interface issues. - Anticipate edge-case user scenarios and embed fail-safe mechanisms into the design. - Ensure products deliver consistent performance across a broad spectrum of operational conditions, including variability in input samples, ambient environments, and user handling. - Apply DFX (Design for Excellence) principles rigorously to enhance manufacturability, assembly, serviceability, and scalability. - Use simulation tools and tolerance stack-up analyses to identify potential design risks early and implement mitigation strategies. - Balance trade-offs, resolve cross-functional conflicts, and align internal and external stakeholders with design priorities. - Mentor and guide a multi-disciplinary engineering design team. - Develop and manage project timelines, define critical development paths, and lead risk identification and mitigation planning. - Clearly articulate design decisions to both technical and non-technical stakeholders. Qualifications Required: - Bachelor's or master's degree in Engineering or related field. - Proven experience in product design and development, preferably in the medical device industry. - Strong expertise in integrating mechanics, optics, microfluidics, electronics, and software. - Experience with simulation tools, tolerance stack-up analyses, and DFX principles. - Excellent communication skills to effectively collaborate with a multidisciplinary team and stakeholders. (Note: Any additional details of the company are not available in the provided job description.),