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Senior Systems Engineer

Alveo Technologies

This is a Contract position in Anaheim, CA posted June 8, 2022.

About Alveo Alveo is leading the transformation of the consumer health tech market with a low-cost, easy-to-use, at-home diagnostic platform that will change the way infectious diseases are detected and managed.

The company’s be.well™ testing system gives individuals access to cutting-edge molecular testing and cloud-based data analytics for rapid diagnosis and management of infectious diseases.

With an initial focus on acute respiratory infections, including COVID-19, Influenza A/B, and RSV, Alveo’s agile and dynamic diagnosis platform can be adapted to detect a wide range of diseases that threaten public health.

Affordable access to real-time, at-home results will transform the way individuals, healthcare providers and public health professionals identify and manage disease outbreaks.

With be.well™, we will Know Sooner, Act Faster™ and make better-informed decisions toward personalized intervention options that benefit individuals and the entire population.

To learn more, visit https://alveotechnologies.com/ Alveo Technologies is looking for a Senior Systems Engineer who has strong experience in methodical and disciplined approaches for the design, development, technical management, and operations of a biomedical system.

This candidate requires a broad diversity of cross-functional technical skills and domain knowledge from mechanical, electrical, biology, fluidics, bioengineering, and test engineering to identify technical risks, challenge design decisions, and bridge the gap between the functional elements of the system development process.

The successful candidate will have experience to integrate consumables, software, hardware, and assays into a fully functional platform for IVD applications.

Primary Responsibilities
• Lead the definition and management of requirements and characterization of the systems/devices that leads to verification and validation.

• Define, plan and conduct formal technical design reviews to ensure customers’ needs are satisfied and designs are consistent with the system-level requirements.

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• Work closely with program managers and cross-functional team members to identify and mitigate technical issues.

• Support failure mode analysis and troubleshooting during product development.

• Lead and apply risk management tools including hazard analysis and FMEA.

• Guide develop and review verification strategies to test designs.

• Maintain system traceability matrix during the product development life cycle.

• Manage the integration of Alveo’s analyzer, software, consumables, and chemicals seamlessly.

• Cross-functional collaboration involving both engineering and assay development.

Minimum Qualifications
• Bachelor’s degree (BS) or higher in a relevant field such as Biomedical engineering, Mechanical Engineering, Electrical Engineering, Applied Physics, Microfluidics, BioMEMS, etc.

• 5 years experience working in medical product development at system level
• 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 manufacturing
• 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, IEC 61010, IEC 60601 and collateral standards.

• Experience with design best practices, including design for six sigma, design for reliability, design for manufacturability.

• Flexibility to work in a rapidly developing environment
• Strong attention to detail required
• Good document generation and familiar with design control
• Demonstrated ability to understand FDA regulations and other compliances
• Excellent communication skills Preferred Qualifications
• Experience in development and commercialization of complex IVD molecular devices under FDA regulations
• Knowledge of a broad range of principles of physics, electrical chemistry, nucleic acid amplification methods, fluidics dynamics, bio-sample preparation, assay development, and biostatistics We are an equal opportunity employer and value diversity at our company.

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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