Manufacturing Engineer - Medical Device

Position : Manufacturing Engineer – Validation and Change ManagementLocation: Avon, IN 46123 -Onsite Duration: 12 MonthsWork Schedule: Monday–Friday, 8:00 AM–4:30 PMClient : Medical Device Equpiment PayRate : $43/Hr on w2

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Position SummaryWe are seeking a hands-on Quality & Manufacturing Engineer to support quality management systems (QMS), engineering change orders, technical documentation, equipment and process validation, and manufacturing operations. The ideal candidate will have experience authoring change orders, leading installation qualifications and protocols, managing controlled documents, and troubleshooting equipment and process issues in a regulated manufacturing environment.This role requires strong technical writing, project management, communication, and leadership skills, with the ability to collaborate across Engineering, Quality, Maintenance, Operations, and external vendors.Key ResponsibilitiesManage QMS activities, including document control, change management, and quality system effectiveness.Manage Windchill work instruction change management, including updates, revisions, and document control.Author and manage engineering change orders, work instructions, and technical documentation using Windchill or similar document management systems.Lead installation qualifications and develop, execute, and evaluate equipment, process, and non-product software qualification protocols.Support temperature mapping, equipment validation, and process validation activities.Review and update work instructions to ensure documentation accurately reflects current manufacturing processes.Provide hands-on troubleshooting and operational support for manufacturing equipment, robotics, printers, and other production systems.Support material setup, repack operations, packaging setup, and manufacturing master data maintenance.Coordinate equipment maintenance, calibration, and preventive maintenance activities.Prepare technical reports, monthly business review metrics, validation documentation, and project updates.Collaborate with internal teams, external customers, vendors, and project stakeholders to resolve technical and operational issues.Lead and support projects, establish objectives, track progress, and drive deliverables through completion.Coach, mentor, and provide technical guidance to peers and Operations personnel.Ensure timely and accurate documentation in accordance with company policies, procedures, and applicable quality requirements.Identify process improvement opportunities and apply engineering principles to solve technical problems.Required QualificationsBachelor’s degree in Science, Electrical Engineering, Software Engineering, Mechanical Engineering, or a related discipline.3–5 years of relevant engineering, quality, manufacturing, validation, or process engineering experience.Hands-on experience with Quality Management Systems (QMS).Experience authoring engineering change orders and managing controlled documentation.Strong technical writing skills, including preparation of protocols, work instructions, reports, and validation documents.Experience leading installation qualifications and developing installation qualification protocols.Experience with equipment, process, or non-product software validation.Strong troubleshooting, problem-solving, project coordination, and communication skills.Ability to work hands-on in a manufacturing or operations environment and manage multiple priorities.Preferred QualificationsLean Six Sigma Green Belt or Black Belt certification is preferred but not required.Experience with Windchill or a similar product lifecycle or document management system.Familiarity with temperature mapping, calibration, preventive maintenance, and manufacturing equipment qualification.Experience supporting robotics, packaging systems, production printers, and operational equipment.Experience with master data management, vendor coordination, and manufacturing process improvements.

Benefits Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.Retirement Benefits: A 401(k) retirement savings plan is available. xzbcwsv No employer matching or other employer contributions are provided.Paid Time Off (PTO): No PTO other than that required by applicable state and local laws