Sunnyvale, CATo support its product development activities, Fluxus Inc. is seeking a highly motivated, interdisciplinary product development engineer with relevant, hands‑on experience. She/He will be part of the product development team and will play a vital role in product prototyping, design, testing and the implementation of manufacturing.She/He will work closely with the other Fluxus teams and will integrate assays/reagents, consumables, instruments, and software. Activities will involve amongst others the development, optimization and manufacturing of functional biochips, fluidic cartridges and analytical instruments. The successful applicant will work within a multidisciplinary team of engineers, scientists and manufacturing personnel. Part of the activities might be conducted in a BSL2 laboratory area and could involve the handling of human patient fluid samples. Other activities might be conducted in a cleanroom setting.Fluxus, Inc. is an innovator in single‑molecule detection and ultra‑high sensitivity platforms based on its expertise in optofluidics, assay development, system integration and microsystem technologies. The Fluxus product development infrastructure and suite of proprietary technologies are ideally suited for the robust development of advanced diagnostic products.Principal duties and responsibilitiesMechanical and Systems Engineering support of diverse aspects related to product development of bio‑chip based, optofluidic, diagnostics platforms and instruments. Applies intensive and diversified knowledge of design principles, practices and implementation in complex systems and assignmentsDevelopment, optimization, testing, sourcing and scale‑up of biochips, cartridges and instruments, in collaboration with other groups and external suppliersSupport all aspects of technology transfer to and from development partnersInterface with internal resources and external vendors to design, test and validate equipment.Support in preparing documentation for-, and managing external suppliers and engineering partners as well as for regulatory submissionsUse Good Documentation Practices (GDP) while authoring DOPs, SOPs, batch records (BRs) and forms (FRs) for various unit operationsProcess development and optimization related to biomolecular sensing.Develop, test and execute QC proceduresWorking knowledge of cGMPs, quality requirements for various regulatory agencies like FDA. Certification is preferredProcess troubleshooting to determine root cause and possible engineering solutionsRequirementsB.S. Degree in mechanical or bioengineering, or related, technical discipline, with 3+ years hands‑on R&D or engineering or product development experienceInterdisciplinary mindsetExtensive, hands‑on experience in mechanical design and in building and operating electro‑mechanic systemsProficiency in CAD design, with statistical analysis software as well as with instrument‑oriented programming language(s) (e.g. Python; LabView)Excellent organizational as well as English verbal and written communication skillsExperienced in using diverse, analytical instruments such as – or similar to – e.g. oscilloscopes, DAQ interfaces, spectrometers, scanning electron microscope (SEM).Ability to develop custom equipment by collaborating with external vendors or internal engineering resourcesExperienced in verification and validation of instruments and processesGood knowledge of data analysis methods including good knowledge of statisticsSelf‑starter, detail‑oriented, motivated, thoughtful, and with a strong work ethicAbility and willingness to quickly learn and apply new skills, procedures and approachesProven ability to work collaboratively in a team‑based environmentProven ability to handle multiple competing priorities in a fast‑paced work environmentOther beneficial skill setsExperience within an industrial product development environment.Hands‑on experience with standard biotech laboratory and/or manufacturing equipment and working with biological or biochemical systems (e.g., proteins, nucleic acids, cells and/or bio‑organic molecules)Experienced in cGMPs and in authoring DOPs, BRs, FRsWorking knowledge of medical device and quality system regulations and standards (i.e. FDA QSR, ISO13485)Experience in building and operating automated and robotic systemsExperience in industrial process FDA QSR, ISO13485.Experience in surface analytical methods and surface modificationAbout Fluxus Inc.Fluxus is a leader in optofluidics that provides systems and solutions to advance the detection, diagnosis, monitoring, and treatment of disease. Our expertise lies at the interface of advanced photonics, MEMS, engineering, assay development, and reagent manufacturing excellence.We seek to close a major gap in clinical research and diagnostics by bringing our groundbreaking ultrasensitive detection technologies and assay solutions to researchers, clinicians, patients, and key industry players through strong partnerships and a future‑proof portfolio of innovative products.Fluxus was founded in 2016 and acquired in 2022 by Fujirebio Holdings, Inc., an R&D‑driven company developing novel IVD technologies and biomarkers with high clinical value.Today, as a wholly owned subsidiary of Fujirebio, Fluxus represents a unique blend of Silicon Valley startup ingenuity with the stability and reach of an established multinational corporation. Our experienced, multidisciplinary team draws on deep and varied expertise to continuously innovate and drive towards our goal of becoming the gold standard in single molecule counting and ultrasensitive biomolecular testing.#J-18808-Ljbffr