Senior Bioprocess Engineer

ARK Diagnostics, Inc.•Fremont, CA

3d•$128,000 - $155,000•Onsite

About The Position

At ARK Diagnostics, Inc., we develop high-performance immunoassays that enable clinicians to make critical treatment decisions. As we expand our manufacturing capabilities, we are seeking an Senior Bioprocess Engineer (IVD) to support the development, scale-up, and commercialization of our assay technologies. In this role, you will work at the interface of R&D and Manufacturing, translating lab-scale products into robust, scalable production processes. You will collaborate with cross-functional teams to support new product introductions, optimize reagent manufacturing, and ensure processes meet the performance, quality, and regulatory standards required in clinical diagnostics. This position is well suited for an engineer or scientist who enjoys solving complex process challenges and improving manufacturing performance in a regulated IVD environment.

Requirements

Bachelor’s or Master’s degree in Chemical Engineering, Bioengineering, Biotechnology, or related field.
5+ years of relevant industry experience; IVD or medical device sector preferred.
Strong knowledge of IVD regulatory frameworks, including IVDD/IVDR, FDA QSR, and ISO 13485 standards.
Hands-on experience with bioprocessing systems, diafiltration/ultrafiltration, and protein purification.
Strong analytical, troubleshooting, and cross-functional collaboration skills in regulated manufacturing environments.

Nice To Haves

Experience with Design of Experiments (DoE) methodologies preferred.
Experience with or understanding of Six Sigma methodologies preferred.

Responsibilities

Design and optimize manufacturing processes for IVD reagents, including antibodies, enzymes, and specialized assay components, ensuring robust performance and reproducibility.
Lead scale-up activities, transferring lab-scale products into high-volume commercial production while maintaining analytical sensitivity, specificity, and quality standards.
Support sustaining engineering efforts by troubleshooting process deviations, investigating non-conformances, and implementing continuous improvement and cost-reduction initiatives.
Drive New Product Introduction (NPI), by partnering with R&D and Quality to transfer new and existing products and technologies into validated manufacturing environments.
Author and execute validation protocols (IQ/OQ/PQ) for equipment and processes to ensure compliance with regulatory and clinical requirements.