Senior Systems Engineer

3 days ago

Oakland, California, United States Alveo Technologies Full time
About Alveo Technologies

Alveo Technologies is a pioneering company in the field of pathogen detection and diagnostics. Our proprietary platform is revolutionizing the way pathogens and infectious diseases are identified and managed.

Our platform uses cutting-edge molecular testing and cloud-based data analytics for rapid identification and diagnosis of a broad range of pathogens in people, animals, crops, and environmental systems.

Job Description

We are seeking a highly skilled Systems Verification and Validation Engineer to lead the definition, design, and execution of verification activities in the product development process. This includes the design of test methods and test strategies, development and execution of verification protocols, analysis and interpretation of results, and communication of results and their impact through written reports, design reviews, and interactive discussions.

Responsibilities:
  • Lead risk management process and activities to ensure regulatory compliance.
  • Apply risk management techniques, hazard analysis, fault tree analysis, failure mode and effect analysis, and FDA benefit-risk analysis.
  • Apply human factors engineering principles in product development.
  • Own formative and summative usability studies, from planning to execution.
  • Determine strategy for testing product requirements, including how requirements will be tested, sample size, resources, and material needs.
Requirements:
  • Develop and write system verification and validation test methods and protocols to evaluate product requirements.
  • Exercise independent judgment and apply solution thinking, problem-solving, and troubleshooting.
  • Execute verification and validation tasks according to established timelines.
  • Develop verification and validation test fixtures where required.
  • Manage the integration of Alveo's analyzer, software, consumables, and chemistry seamlessly.
  • Write reports and log issues for executed verification tests.
  • Participate in technical reviews and design reviews.
  • Contribute to Systems team efforts by performing other duties as required.
  • Cross-functional collaboration involving both engineering and assay development.
Qualifications:
  • Bachelor's degree (BS) or higher in a relevant field such as Mechanical Engineering, Applied Physics, Microfluidics, Biomedical Engineering with mechanical emphasis, Human Factors Engineering, or related field.
  • Expert in risk management process and associated activities.
  • Proficient in human factors engineering.
  • 5+ years of experience in systems verification and validation in IVD or medical devices industry.
Preferred Qualifications:
  • Experience in development and commercialization of complex IVD molecular devices under FDA regulations.
  • Strong attention to detail required.
  • Knowledge of a broad range of principles of physics, electrical chemistry, nucleic acid amplification methods, fluidics dynamics, bio-sample preparation, assay development, and biostatistics.

Salary range for this position is $150,000-$165,000 per year.

We are an equal opportunity employer and value diversity at Alveo Technologies. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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