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Sr. Manufacturing Engineer - Packaging/Final Visual Engineer

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Engineering
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190003VZ Requisition #
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Careers that Change Lives
Medtronic’s Tempe, Arizona Microelectronic Solutions location is looking for a Senior Manufacturing Engineer who will provide support for the 24x7 Hybrid Manufacturing. The ideal candidate will have a passion for the patients we serve and an unrelenting desire to improve our business.

Medtronic is intensely focused on creating a workplace environment which reflects our standing as the world’s top medical device company. The person that takes this role will be expected to play an active role in supporting the sustaining and continuous improvement activities within the Hybrid Manufacturing Process Engineering organization.

The candidate will have a general working knowledge of Printed Circuit Board micro-electronics packaging manufacturing technologies and demonstrate an ability to apply problem solving skills and pragmatic thinking while working in a high paced team-oriented environment.

A Day in the Life
The focus of this role will be for production support for the packaging and final visual operations while serving as a focal point for handling all mechanical related questions/issues/returns from the internal customer factories. The selected candidate will have general/broad understanding of FDA compliance requirements and exposure to audits from regulated agencies.

In this role, you will lead and/or support
• All final pack and final visual inspection process steps; Lead all change control and regulatory documentation submissions for key process changes
• Act as focal contact point for all mechanical related questions/issues/ returns for analysis from our internal customer factories; work cross functionally with process owners to answer and close related product investigations
• Medical device packaging manufacturing support. Projects scope could include ideation, design, development, validation and manufacturing support.
• Evaluate various material and design options for device packaging to meet overall product life cycle needs: product handling/shipping needs, environmental, distribution and storage requirements. Research, procures and validate packaging process equipment/tooling/fixtures and related documentation to support manufacturing.
• Design, develop, source and specify packaging components based on product characteristics, cost limitations, and in accordance with EPA, FDA and DOT regulatory requirements. Package design and material selection will take into consideration such variables as moisture, chemical compatibility, temperature degradation and distribution performance
• Performs troubleshooting on new packages/products/process problems as related to design, material, or process
• Develop package testing protocols, test acceptance criteria, and analyzes results
• Create packaging component specifications and drawings for procurement and inspection of packaging components
• Train manufacturing on packaging assembly and use of machinery and label printers.
• Evaluate final visual process steps for optimization, workstation layout, ergonomic improvements and other process improvements; team with other process owners to provide real-time feedback on key process indicators impacting final visual yield

Must Have – Minimum Requirements
• Minimum of a Bachelor’s degree in Engineering
• 4+ years of experience with Bachelor’s degree, 2+ years with advanced degree

Nice to Have
• Degree in Mechanical Engineering or Packaging Engineering desired
• 3+ year experience in packaging engineering, medical device related preferred
• Experience in performing/leading IQ/OQ/PQ & Gage R&R /MSA studies
• Process characterization and optimization using DOE methodology; FMEA experience required; Set up the control charts and make control plan; utilize FMEA risk assessment to design/improve the process to reduce risks
• Working knowledge of computer aided drafting (CAD, SolidWorks) and label design software (Bartender).
• Working knowledge of FDA and international regulations such as ISO, ASTM and ISTA test standards and methods related to packaging and labeling.
• Experience with use of statistical process control and data analysis tools.
• Experience with Lean Sigma/DFSS/DRM/DMAIC methodology
• Experience with IPC-A-610 Acceptability of Electronics Assemblies Class 1/2/3
• Minimum of 2 years of relevant microfabrication/ SMT experience
• Knowledge of micro-electronic packaging manufacturing technologies and equipment and processes including Die Attach, Wirebond, Transfer Mold, Direct Chip Attach, solder paste and reflow processes, PWB final sizing technologies including mechanical Rout/De-panel, Wet Saw Singulation and Excise, and dimensional verification using optical metrologies for packaging assembly.

About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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