Systems Verification & Validation Engineer
Alameda, CA, USA
Posted on Saturday, October 7, 2023
Alveo is leading a transformation and evolution in global pathogen detection and diagnostics with a proprietary platform that changes the way all manner of pathogens and infectious diseases are detected and managed. The company’s globally patented pathogen identification and diagnostic 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. Alveo’s agile and dynamic diagnostic platform can be adapted to detect a wide range of fungal, bacterial and viral pathogens that threaten people, animals, food supplies, and water which impact public health. Access to highly accurate, real-time, geo-located pathogen identification at the Point-of-Need (PoN) is transforming the way the world identifies, communicates, and addresses everything from livestock health and global pandemics, to crop yields and water quality. Alveo empowers the world to Know Sooner, Act Faster™. To learn more visit https://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.
· Lead 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
· Develop verification and validation test fixtures where required.
· GLP experience such as, pipetting, volumetric calculations, mixing and assay set up.
· Manage the integration of Alveo’s analyzer, software, consumables, and reagents 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, software development, and assay development.
Your Background Should Include:
· Bachelor’s degree (BS) or higher in a relevant field such as Mechanical
Engineering, Applied Physics, Microfluidics, Biomedical engineering with
mechanical emphasis or related field.
· 2- 5 years industry experience in systems verification and validation in IVD or
medical devices industry.
· Strong root-cause analysis skills to troubleshoot issues and solve
· 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 documentation practice - and knowledge of design control.
· Excellent communication skills in an efficient and effective manner.
· 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 $118,233 - $132,237 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.