Process Engineer - Combination Drug Delivery Devices

Job Title: Process Engineer - Combination Drug Delivery Devices*Need local to WIJob Description:Genentech is seeking a Process Engineer to support the commercialization of combination drug delivery devices for parenteral therapeutics. This role focuses on advancing high-volume manufacturing processes, supporting clinical and commercial scale-up, and ensuring product quality through robust engineering practices.Key Responsibilities:Lead process development activities, including DFM/DFA assessments, equipment procurement, and method development.Develop and validate manufacturing processes using tools such as DOE, FMEA, tolerance analysis, and statistical modeling.Support device assembly, testing, and quality control in alignment with design control and regulatory standards (ISO 13485, GMP).Collaborate cross-functionally with internal teams and external partners to translate design requirements into scalable production processes.Author and review technical documentation including SOPs, protocols (FAT, IOQ, PQ), validation reports, and DHF records.Drive root cause analysis, CAPAs, and process improvements within a compliant quality system. Qualifications:B.S./M.S. in Mechanical Engineering or related field.3+ years of experience in high-volume manufacturing, especially in plastic molding and mechanical assembly.Proficiency with statistical tools (JMP, Minitab), Six Sigma (Green/Black Belt preferred), and process validation.Familiarity with GMP, ISO 13485, FMEA, and risk management practices.Experience in design transfer, equipment qualification, and working with control systems and production automation. Preferred Skills:Expertise in assembly and test equipment (e.g., heat staking, laser welding, leak/flow testing).Strong documentation, communication, and cross-functional collaboration skills.Experience with external manufacturing partners and regulated environments.