Manufacturing / Industrial Engineer, Staff
Business Unit: Point of Care
Requisition Number: 224261
Primary Location: United States-Indiana-Mishawaka
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 10%
Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.
With 45,000 employees Siemens Healthineers is one of the world’s largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers’ needs. So that more people can have a life that is longer, richer, and more filled with happiness.
For more information, please visit: http://www.usa.siemens.com/healthineers
About Siemens Healthineers
Siemens’ Healthcare Sector is one of the world's largest suppliers to the healthcare industry and a leader in medical imaging, laboratory diagnostics, medical information technology and hearing aids. Siemens Healthcare offers its customers products and solutions for the entire lifecycle of patient care – from prevention and early detection, to diagnosis, treatment and aftercare. By optimizing clinical workflows for the most common diseases, Siemens also makes healthcare faster, better and more cost-effective. Siemens Healthineers employs over 50,000 employees worldwide. In fiscal year 2011, the Healthcare Sector posted revenue of 12.5 billion Euros. For more information on the Healthcare sector, visit: www.siemens.com/healthcare.
Siemens Healthcare Diagnostics is committed to the business of in vitro diagnostics worldwide. Our global presence and capabilities are strong. We have 4 billion Euros in sales and approximately 14,000 employees serving approximately 30,000 customers in more than 170 countries.
Our expertise continues to gain momentum with more than 160,000 instruments installed. Siemens Healthcare Diagnostics invested over 300 million euros in 2012 in R&D, representing approximately 8% of our global sales. This investment and focus in R&D continues to place us in a very strong position to provide unique and relevant customer-driven innovations.
This individual will support the plant manufacturing effort, with proven ability to identify problems and pursue plans toward their resolution in a highly fast paced automated medical device manufacturing environment.
- Plans and guides the development, implementation and maintenance of manufacturing methods, processes, and operations for new and existing products.
- Mentor engineers, technicians and skill trades to develop in house talent on current and new processes as well as trouble shooting chronic equipment issues.
- Develop URS and work with OEM vendors to write capital justification for purchase, installation and validation of new equipment and processes.
- Specific focus will be in areas of improving and resolving chronic issues that will lead to increase in overall equipment effectiveness (OEE).
- Technical work may be complex and difficult to relate to existing technologies, requiring broad application of knowledge and principles
- Demonstrated innovation, creativity and problem solving skills in a fast paced, global environment.
- Experience with multiple manufacturing processes (i.e. PLC Automated Equipment, Thermal Heat Sealing, Ultrasonic Welding, Dispense System, Robotics, Pick and place systems, Vision systems, web handling, packaging and labelling systems)
- Capable of creating designs of parts and mechanical subassemblies using in-depth knowledge of materials and processes to meet extremely challenging technical requirements.
- Responsible for the Environmental and Health & Safety effects of the work performed
- Keep up to date on new developments and technologies in assigned disciplines and present on new ‘Best Practice’methodologies, procedures, processes and equipment to the company in a proactive manner.
- Engage with the appropriate personnel in the identification and resolution of corrective/Preventative actions to address Quality, Technical, and Manufacturing issues (Audit Actions, NCR’s, CAPA’s, etc).
- Responsible for identification and implementation of equipment related continuous improvement activities to improve product quality and increase Overall Equipment Effectiveness.
- Responsible for all associated documentation, including but not limited to, the following: Validations, Standard Operating Procedures, Preventive Maintenance Schedules, Engineering Change Notifications, Spare Parts Listings, etc. in line with FDA regulations.
* BS degree in engineering or equivalent experience (i.e. Mechanical, Electrical, Automation, Manufacturing )
* 8 - 10 years of relevant experience
* Experience in installation, validation and troubleshooting of automated industrial production equipment.
* Previous work experience in IQ/OQ/PQ and Process Validation protocols for Quality System (QS) Regulation/Medical Device Good Manufacturing Practices within an FDA regulated environment that is ISO certified.
*Experience in New Product Launches to manufacturing and manufacturing transfer of product lines.
*Experience with multiple manufacturing processes (i.e. PLC Automated Equipment, Thermal Heat Sealing, Ultrasonic Welding, Dispense Systems, Robotics, Pick and place systems, Vision systems, packaging and labelling, Pneumatics etc.)
* Experience in TPM