Senior Manufacturing Engineer – Sterile Packaging

Senior Manufacturing Engineer – Sterile Packaging

Requirements

• Bachelors degree required and a minimum of 4 years of relevant experience OR an advanced degree with a minimum of 2 years relevant experience

Responsibilities

• Be responsible for the development of all metal finishing, assembly and packaging methods for assigned product lines.
• Partner with Project Engineer and determine Make vs. Buy decisions.
• Participate during print review, partner with Quality Engineering on determining gages and measurement procedures.
• Creates conceptual designs for new fixtures, gages and special cutting tools. Conducts tool design reviews with Tooling Team personnel, purchasing personnel and outside tool suppliers.
• May determine appropriate machine platform for product and review any necessary capital equipment requirements.
• May represent Warsaw on new product launch activities and transfer of product.
• Completes activities of the change control policy and Corrective and Preventive Action (CAPA) system in accordance with Medtronic Corporate CAPA system.
• Completes activities of Lean Sigma projects and process improvements
• Review product drawings for manufacturability. Initiate drawing changes with the product design engineer to improve manufacturing quality and reduce costs.
• Provide periodic updates of assigned projects to senior management, maintain project documentation, project plans, action item registers and actively manage risks related to cost, quality and schedule.
• Partner with Quality during risk management activities. May lead and/or actively participate in design reviews, i.e.: DFMEA & pFMEA
• Provide technical support to purchasing personnel and suppliers by interpreting product drawings, initiating the development of manufacturing drawings and resolving technical production problems.
• Develop the manufacturing plan for new products and coordinates the entry of Manufacturing Process Planning information into the MRP system.
• Proactively execute and support development of validation/qualifications studies. Determine strategy with appropriate teams and ensure that groups are involved early on in the needs of the engineering group.
• Develop manufacturing setup/process sheets for all assembly, and finishing operations for new products.
• Review engineering drawing changes and make/initiate appropriate changes in manufacturing tools, fixtures, processes, programs, bills of material or routings. Documents all changes through the Manufacturing Engineering process control system.
• Resolve technical production problems on assigned product lines in finishing and assembly and packaging operations working with shop employees and quality personnel.
• Conduct technical manufacturing reviews of suppliers to support purchasing personnel certifying suppliers.
• May make recommendations to management on plant layout.
• May recommend and implement plant equipment acquisitions. Work with equipment suppliers on equipment specifications, quoting of specified equipment and delivery schedules.
• Initiate and direct improvements in current manufacturing methods and processes to improve past quality schedule performance and to reduce manufacturing costs.
• May lead in the training of new Team personnel.
• Train shop employees on new manufacturing methods, products and new production equipment.
• Travel as required for company business transactions.
• Support product launch and core business initiatives by utilizing project management tools. Seek resources, track and communicate status of product launch, provide solutions to launch issues and opportunities. Collaborate with key stakeholders to ensure smooth transition of design from concept to delivery.
• Ensure processes and procedures are in compliance with regulations (21 CFR 820).
• Performs other duties as assigned.

Preferred Qualifications

• Clean room monitoring and control experience
• RO/DI water system support and troubleshooting experience
• Sterile packaging experience
• 5+ years of Manufacturing Engineering experience
• GDP/GMP
• Validation planning and execution experience
• Process mapping/Control plan Generation
• Ability to review and update drawings
• Experience with creation of FMEAs
• Statistical analysis using (e.g.) Minitab
• CAD experience such as Creo, NX, Autocad etc
• Working Knowledge of Agile Map
• Experience using SAP
• Experienced in Supplier Engagement and support
• Experience working in Medical Device Industry and with 13485/FDA requirements