Senior Systems Engineer

About Alveo

Alveo Technologies is the first company to make molecular detection and diagnostics universally accessible – on the farm, in the field, in the clinic, or in the manufacturing plant – helping prevent or significantly limit the destructive impact of viruses, fungi, bacteria, and other pathogens by detecting earlier at the Point of Need™. Alveo’s rugged and portable, multiplex-capable diagnostic platform employs IntelliSense™, its patented method of direct electrical sensing of nucleic acid amplification to provide affordable, rapid, and accurate results. By enabling early pathogen detection, Alveo helps manage global health, food security, and supply chain resiliency by providing actionable insights at lightspeed. Know Sooner, Act Faster™ with Alveo. For more, visit: https://www.alveotechnologies.com/ 

Alveo Technologies is looking for a systems V&V 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. The successful candidate will have experience to integrate consumables,

software, hardware, and assays into a fully functional platform for IVD applications.

Responsibilities:

· 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.

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 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.

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.