ABOUT AVAILS:
Avails Medical, Inc., is a well-funded medical device start-up based in Menlo Park, California. We are a leader in the development of rapid, automated and fully electrical antibiotic susceptibility testing (AST) technologies with our products eQUANT™ and eAST™ platforms based on a novel bio-sensor for rapid infectious disease detection. In 2024, we have announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for our groundbreaking eQUANT™ system. The eQUANT™ system is a leap forward in combating antibiotic resistance, providing a standardized inoculum (0.5 McFarland equivalent) directly from positive blood cultures.
We are dedicated in our drive to make rapid AST accessible and affordable to hospital microbiology labs, empowering them to provide actionable infectious disease treatment information with simplified laboratory workflows to save lives, reduce outcome costs and reduce the threat of global antimicrobial resistance.
We are looking for a highly technical, nimble and talented self-motivated engineer with a penchant for solving problems and passion for project managing cross functional diciplines efficiently and effectively. Are you ready to join us as we embark on this next phase of growth?
ESSENTIAL JOB FUNCTIONS / RESPONSIBILITIES:
- Lead the integration of product technologies of Avails electronic IVD products of its electrical sensors, embedded systems, algorithms, hardware, software, assay, and disposable cartridges.
- Perform product development activities, such as defining product concept, requirement specifications, architecture/design, testing, etc. in a medical device design-controlled process.
- Support on-market medical device products according to customer requirements and applicable regulatory and quality standards
- Translate experimental results into design criteria.
- Lead the technical development strategy for the project.
- Interface and guide external contract design and engineering partners.
- Work with contract manufacturers to transfer design and validate manufacturing processes.
- Create and execute test plans and system Verification and Validation activities
- Assess, develop, implement, troubleshoot, and document new test methods, solutions, and designs to improve system reliability and manufacturability.
- Design and execute experimental studies to guide new products as well as design improvements.
- Interface directly with the management team on project status/issues.
- Perform failure root cause analysis using tools such as FMEA, FTA, 5 why, fishbone, etc.
- Maintain compliance as required by regulatory bodies and the company’s quality system.
- Support FDA and other regulatory submission and audits.
EDUCATION REQUIREMENTS:
- Degree in technical disciplines such as Physics, Engineering (Mechanical, Electrical, Chemical), Bioengineering or related discipline
- Bachelors: 10+ years of relevant experience, Masters: 5+ years of relevant experience, PhD: Study in related field and 2+ years with relevant experience
EXPERIENCE REQUIREMENTS:
- Experience in complex system analysis from concept through commercialization.
- Experience developing product requirements and design inputs.
- Previous experience in the IVD Medical Device industry related to design controls with a focus on user needs, intended use, system requirements, system design and traceability is a plus.
- Familiarity with instrument and consumable development and/or liquid assays preferred.
- Knowledge and experience in biology lab practices.
PERSONAL TRAITS:
- Self-motivated with a passion for solving problems across several projects and disciplines efficiently.
- Ability to work independently and in team focused projects.
- Ability to work in a fast-paced, highly technical, interdisciplinary team.
- Excellent record-keeping skills required.
- Strong communication skills (verbal & written).
TRAVEL REQUIREMENTS: Occasional travel may be required.