Manufacturing Engineer

Manufacturing Engineer – Contract (12+ months) Location: Mansfield, MA Pay Range: $50–$60 per hour (variable based on experience, education, and location) Position Responsibilities Generate and execute validation plans, protocols (IQ/OQ/PQ), and completion reports, focusing on sterilization and microbiology of medical devices. Provide statistical analysis of data to support reports; generate and implement change controls and engineering notices (ECO). Develop statistically based sampling plans for in‑process and final testing, inspections, and validations. Troubleshoot 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‑conformance incidents and protocol deviations. Complete assigned Non‑Conformance and CAPA investigations and prepare investigation reports. Maintain effective cross‑functional relationships with plant and corporate Manufacturing, Engineering, Regulatory, and QA personnel. Work on project teams with internal departments, external vendors, and customers as required. Ensure compliance with regulatory and international agencies such as FDA, ISO, OSHA, EPA, and others. Participate in the compilation and review of technical documentation for domestic and international regulatory submissions. Participate in external audits (FDA, Notified Body, corporate, etc.) and perform related duties as necessary. Qualifications Knowledge of FDA, OSHA, EPA, GMP, and ISO requirements. Knowledge in Organizational Excellence and Lean/Six Sigma. Ability to lead teams through complex projects and provide departmental technical leadership. Proven strategic thinking ability. Experience developing technical documentation such as Change Controls, Validation Plans, Protocols, Investigation Reports, SOPs, etc. Education and Experience B.S. in Engineering (Mechanical, Industrial, Electrical, Chemical, Biomedical, or related science) or Professional Engineer License; Lean/Six Sigma Green or Black Belt certification is a plus. Experience in validations of manufacturing equipment, processes, stability/aging. Minimum of 7+ years in the medical device and/or pharmaceutical manufacturing environment. Equal Opportunity Employer/Veterans/Disabled Benefit offerings for associates include medical, dental, vision, life insurance, short‑term disability, voluntary benefits, an EAP program, commuter benefits, and a 401(k) plan. Associates may be eligible for paid leave and holiday pay as applicable. Disclaimer: These benefit offerings do not apply to client‑recruited jobs and direct hires. If you are interested in this Manufacturing Engineer role, please click APPLY NOW . For other opportunities, visit Contact Sunny Kumar at View email address on click.appcast.io for questions. #J-18808-Ljbffr