Careers that Change Lives
A Day in the Life
MITG
The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.
RESPIRATORY INTERVENTIONS
Respiratory Interventions (RI) offers technologies to support patients in need of respiratory assistance through ventilation, airway access, and airway support accessories.
Develop and deliver the medical device breakthroughs that make a difference in the lives of millions of patients.
Does this work inspire you?
Work with design and manufacturing teams to make product and process changes to medical device equipment. Use quality engineering concepts, including but not limited to design control, process control, risk management, supplier quality, and continuous improvement.
Ensure desired design and product performance levels are met in compliance with all applicable regulatory requirements and Medtronic Policies and Procedures.
What is the work you will be doing?
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Learn the medical device industry requirements and guidance including the Quality System Regulation, ISO 13485, Medical Device Directive, Medical Device Regulation, ISO 14971, IEC 60601 and other standards.
Support the development of medical devices in conformance with these requirements.
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Assist in compiling trending and post market vigilance data for monthly meetings
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Ensure internal Design Control and Process Control policies and procedures are implemented on design and process change projects.
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Provide guidance on the application of internal procedures, including Design Control and Process Control, to the development teams, within the framework of regulatory requirements.
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Serve as project core team member representing Design Quality.
Interact and form constructive working relationships with development and manufacturing team members.
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As a core team member on change development projects, perform or contribute to the development of the following:
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Product Risk Assessments and Process Failure Mode Effects Analyses
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Design Updates
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Design Verification and Validation strategies and acceptance criteria
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Risk based sampling plans
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Process Capability Analyses
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Post Market Surveillance Reports
Must Have: Minimum Requirements
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