Intellectt Inc is hiring: Manufacturing Engineer II in Mansfield

Role: Manufacturing Engineer II Location: Mansfield, MA - 2048 Duration: 8 Months Job Description: Primary responsibilities are to: • Create, update, and maintain equipment service work instructions. • Organize and write validation protocols associated with the manufacturing process • Lead and support troubleshooting activities to minimize process downtime or re-occurrence • Identify key process indicators and collect data to drive manufacturing and yield improvements Responsibilities: • Generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports, with a major focus on sterilization and microbiology of medical devices. • Generation and implementation of change controls and engineering notices (ECO). • Develop statistically based sampling plans for in-process and final testing and inspections, and validations. • Troubleshooting equipment/processes that do not perform as intended during validation runs. • Recommend process/quality improvements as part of validation runs. • Evaluate, investigate and document non-conformances incidents and/or protocol deviations. • Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports. • Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel. • Work on project teams with other internal departments, external vendors, and customers as required. • Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others. • Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions. . • Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others. Performs other related duties as necessary. • Qualifications: Knowledge of FDA, OSHA, EPA, and GMP and ISO requirements. Knowledge in Organizational Excellence and Lean/Six Sigma. Strong Project • Management skills. • Ability to lead teams through complex projects and provide departmental technical leadership. • Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others. Teamwork oriented and self-starter. Education and/or experience: BS in Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical (Professional Engineer License.) or sciences related field. • Lean/Six Sigma Green or Black Belt Certification is a plus. • Experience in validations such as: manufacturing equipment, manufacturing processes, stability or aging, required.