Senior Systems Engineer

6 days ago

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Alveo Technologies

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Health Tech • Portable Diagnostics • Assay Development • Microfluidics • Infectious Disease Detection

51 - 200

💰 Series A on 2021-04

Description

• Lead risk management process, activities to ensure regulatory compliance. • Proficiency in the application of risk management techniques, hazard analysis, fault tree analysis, failure mode and effect analysis and FDA benefit-risk analysis. • Mastery in the application of human factors engineering in product development. • Own formative and summative usability studies; planning through execution. • Familiarity with the definition, design and execution of system verification activities. • Determine strategy for testing product requirements, including how requirements will be tested, sample size, resources, and material needs. • 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. • Wet lab experience such as pipetting, volumetric calculations, mixing and GLP. • Manage the integration of Alveo’s analyzer, software, consumables, and chemistry seamlessly. • Write reports and log issues for executed verification test. • 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.

Requirements

• 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 experience in systems verification and validation in IVD or medical devices industry. • Strong root-cause analysis skills to troubleshoot issues and solve interoperability problems. • Excellent hands-on experience to create and conduct test methods and DOEs to mitigate system interface issues and implement test methods in product development. • Proven ability of data analysis with various data analysis software packages such as Matlab, Minitab or similar. • Knowledge of regulatory standards applicable to design of medical devices, including ISO 13845, ISO 14971, 21 CFR 820.30 and collateral standards. • Flexibility to work in a rapidly developing environment. • Strong attention to detail required. • Good document generation and familiar with design control. • Excellent communication skills in an efficient and effective manner.