About the Company

Openwater is creating next-generation open-source medical technologies that can enable us to diagnose and treat potentially 100s of diseases with a single device. With this advancement comes the promise of treatment of debilitating diseases including cancer, mental disease, stroke, COVID/Long COVID and longevity treatments. We already have a trove of clinical data demonstrating the promise of our technology, and now Openwater is the world’s first open-source, open-patent, open-clinical-data, and open-safety-sharing company, centered on the new idea of the Silicon Hospital.

About the Role

We are seeking a highly skilled Medical Device Design Quality Engineer to join our team and ensure that our products achieve the highest quality standards for functionality, performance, safety, and reliability. The Design Quality Engineer provides design control, documentation and compliance expertise consistent with U.S. and international regulations and standards. The quality engineer is part of an engineering team which is working in a regulated environment.

Location: San Francisco, USA

Responsibilities:

• Lead proactive design assurance activities facilitating the development and release of high-quality products.
• Review and approve product design documents in accordance with design controls standards and the Company’s policies.
• Support audits and compliance assessments of DHF and other program files to ensure quality and regulatory requirements are met.
• Review and interpret product specifications, ensuring all hardware, electrical, mechanical, and firmware components align with functional, performance, safety, and reliability requirements.
• Develop quality processes and assist in implementation, especially for design and development.
• Partner with engineering to ensure design control processes are maintained and continuously improved to ensure on-going compliance to all applicable regulation and standards.
• Assure proper documentation and execution of design planning, inputs and outputs, design review, V&V, risk analysis and design change per company and regulatory requirements.
• Identify and provide guidance for the application of harmonized standards to product development.
• Set quality assurance testing models for analysis of raw materials, materials in process, and finished products
• Incorporate feedback on manufacturability, safety compliance and customer response into product requirements
• Perform mathematical modeling, Life time predictions, and complex reliability analysis techniques on designs to determine and simulate the life of the product in the field.
• Perform or coordinate failure analysis and field performance investigations.
• Lead complaint root cause analysis and recommend related improvements.
• Perform risk assessments to proactively identify and mitigate potential hardware design risks.
• Participate in cross-functional teams to resolve reliability issues as they arise.
• Stay abreast of changes in medical device regulations and standards to ensure ongoing compliance.

Qualifications:

• BS degree in electrical engineering, mechanical engineering, biomedical engineering, or a related field.
• Minimum 5 years of experience in hardware product quality, design verification, and testing for medical devices.
• Expertise in analyzing, troubleshooting and resolving complex issues.
• Ability to balance the needs of a fast-paced start-up environment with the needs for good documentation and quality control.
• Strong understanding of IEC 60601 and requirements for compliance.
• Knowledge and competency in application of FDA, ISO 13485, ISO 14971, MDR, and other regulatory requirements, especially in the area of quality systems and design control as applied to projects from design inception to manufacturing release.
• Experience with the following techniques: Hazard Analysis, Risk Analysis, FMEA.
• Experience with medical electronic products development including hardware design, verification, and validation phases.
• Experience in hardware bring-up, characterization and failure analysis.
• Experience with the full product life-cycle (Concept, Specification, Design, Verification, Manufacturing & Sustaining).
• A demonstrated ability to create comprehensive test strategies and plans based on design specifications.
• Effective collaboration skills to work with cross-functional teams.
• Attention to detail and a data-driven approach to testing and validation.
• Ability to communicate complex information clearly and concisely, both orally and in writing.