Process Engineer II

Position Overview Process Engineer II – responsible for owning and investigating manufacturing related non‑conformances, ensuring timely resolution to maintain on‑time product delivery, and supporting the piloting team in creating small‑scale batches that support R&D and manufacturing efforts. Reports to the Manager, NPI and OEM; part of the Manufacturing Technical Operations team located in West Sacramento; on‑site role. Responsibilities Support Internal Quality KPI Leads and resolve internal non‑conformance investigations (assessment of non‑conforming product, root cause investigations, corrective and preventative actions). Provide technical support for Operations (design of experiments, technical writing, analytical testing – HPLC, UV‑Vis spectroscopy, and bioassay). Support Factory OTD and schedule attainment of finished products. Lead and resolve customer manufacturing related CAPA and PLRA (post‑launch risk assessment). Support manufacturing of pilot runs and troubleshoot associated deviations. Qualifications Bachelor’s degree in Microbiology, Biomedical Engineering, or a science‑related field with 3+ years’ experience OR Master’s degree in the field with 0+ years’ experience. Experience working in medical device manufacturing, pharmaceutical, or other regulated environments. Demonstrated skills in root cause investigation, problem solving, and implementing corrective actions. Excellent written and oral communication of technical data and ability to lead productive team meetings. Ability to work with cross‑functional teams to investigate manufacturing defects, perform data analysis, and write informed, risk‑based technical justifications for product release. Preferred Experience Hands‑on laboratory experience in Microbiology or other biological sciences, including exposure to biological sample preparation, cell culture, and analytical assays such as HPLC and UV‑VIS spectrophotometry. Experience with Danaher Business System (visual project management, value stream mapping, standard work), Lean, Kaizen, Six Sigma, Problem Solving Process (PSP), risk management, process validation, design of experiments, and design change. Salary and Benefits Salary range: $74,000 – $90,000. Eligible for bonus/incentive pay. Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k) for eligible employees. Equal Opportunity and Inclusion Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. Applicable federal and state disability laws are complied with, and reasonable accommodations are made for applicants and employees with disabilities. #J-18808-Ljbffr Radiometer