Senior R&D Systems Engineer
2 weeks ago
About Avails Medical, Inc.
We are a leader in the development of rapid, automated, and fully electrical antibiotic susceptibility testing (AST) technologies with our products eQUANTTM and eASTTM platforms based on a novel bio-sensor for rapid infectious disease detection.
Our mission is 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.
Key Responsibilities:
- Lead the integration of product technologies of Avails electronic IVD products, including 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.
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.
Preferred Qualifications:
- 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.
- Familiarity with instrument and consumable development and/or liquid assays.
- Knowledge and experience in biology lab practices.
Personal Qualities:
- 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.
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