Sr Process Engineer II

Sr Process Engineer Location: Ann Arbor, Michigan Key Responsibilities Demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Leading the design, build, and commissioning of custom manufacturing equipment and automation systems for medical device production. Collaborating with R&D, Quality, and Operations to translate product requirements into scalable manufacturing solutions. Developing and optimizing process flows, equipment specifications, and validation protocols (IQ/OQ/PQ). Driving continuous improvement initiatives using Lean, Six Sigma, and other methodologies to enhance throughput, yield, and reliability. Managing capital projects, including vendor selection and coordination, budget control, and timeline adherence. Ensuring all equipment and processes comply with FDA, ISO 13485, and other applicable regulatory standards. Supporting root cause analysis and corrective actions for process deviations and equipment failures. Maintaining documentation and traceability for all engineering activities, including design history files and risk assessments. Utilizing the systems and processes in place to attract, develop, engage, train, and retain talented Associates; creating a work environment where Associates can realize their full potential. Performing other duties as assigned. Qualifications Bachelor’s or Master’s degree in Mechanical, Electrical or Industrial Engineering. Minimum of 8 years of experience in equipment design and process engineering within a regulated manufacturing environment. Strong technical expertise in electromechanical systems, process validation, and equipment development. Proven experience with validation protocols (IQ/OQ/PQ), root cause analysis, and CAPA processes. Proficiency in Lean, Six Sigma, or other continuous improvement methodologies. In-depth understanding of FDA, ISO 13485, and other relevant regulatory standards. Prior experience in the medical device industry, especially cardiac devices or implantables. Familiarity with process characterization, tooling, fixture development, and automation systems. Experience working with low-volume, high-precision manufacturing environments. Knowledge of soldering, plastics, metals, or packaging processes within regulated industries. NO C2C CANDIDATES JBL is an Equal Opportunity Employer and E-Verify Company #J-18808-Ljbffr