Staff Engineer, NPI & Transfers (Chemistry)

Job description

Location MV Aliso Viejo, California, USA: Department Name: 320-Indirect Manufacturing Qualifications: - Bachelor's degree in Mechanical/Manufacturing/Chemical/Industrial Engineering or related field - minimum of six (6) years of relevant manufacturing process development experience in the medical device and/or pharmaceutical industry - Strong written and verbal communication skills - Proficient computer skills including MS Word, Excel, Outlook, Teams, and CAD Desired Qualifications: - Advanced degree in Engineering or related field - A minimum of eight (8) years of relevant manufacturing process development experience in the medical device industry - Proven ability to design, develop, and validate manufacturing processes of medical devices and working knowledge of cGMP - Knowledge of statistical tools including Design of Experiments (DOE) and Cpk for process development, characterization, and optimization preferred - Knowledge of process design, optimization and validation (IQ, OQ, PQ) - Familiarity with statistical tools (e.g., Minitab) - Proven knowledge of Lean/Six Sigma techniques (Green or Black Belt a plus) - Ability to solve complex manufacturing problems - Demonstrated abil...