Configuration Administrator

Skills

1. Work with project teams to facilitate creation and driving of engineering Change Orders (CO’s) through the sign-off process. 2. Work with Agile Product Lifecycle Management (PLM) system and Quality configuration managers to release change orders and drive process improvement. 3. Interact with cross-functional team members as required to process CO’s. 4. Monitor the status of ongoing change orders and notify team members of required approvals or document updates. 5. Review submitted documents for all applicable regulations standards best practices and company procedures. 6. Follows process closely to ensure proper change order type document type BOM structure signature requirements alignment with product model numbers GTINs and UPNs and alignment with other enterprise systems. 7. Construct plans in spreadsheet or other format and communicate status to project team. 8. Other possible assignments include supplier check-ins creating and maintaining compliance records for applicable hazardous substance regulations compose & maintain compliance documentation.

Description

Medtronic is a global leader in medical technology, services, and solutions that take on the healthcare industry's greatest challenges. Join the Cardiac Surgery team and help us bring the next generation of life-changing medical technology to patients worldwide. At Medtronic, we push the limits of what technology 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. Come for a job, stay for a career.
This position acts as a specialist in change order management assisting engineers and technicians with release of documentation, specifications, bills-of-material (BOM) and other design artifacts into a formal life cycle management system. This position is within a product development team and may support multiple development teams in concurrence. The successful candidate will have strong organization and communication skills, excellent attention to detail and the ability to follow procedures closely.

Responsibilities

• 1. Working knowledge of PLM systems and Change Management basics.
• 2. Quality Systems and Quality Records knowledge.
• 3. Basic knowledge of Medical Device manufacturing requirements.
• 4. Experience in Medical, Pharma or high reliability product industry.
• 5. Experience managing change orders using Agile tools for Product Lifecycle Management.
• 6. Experience managing Bills of Materials in pre- and post-production settings.
• 7. Excellent attention to detail.
• 8. Strong technical writing, communication skills.
• 9. Solid organizational and time-management skills.
• 10. Exposure to blood management, cardiac ablation or perfusion medical devices.
• Familiarity with Product Development Process, Regulatory Submission Process, Quality Management Systems, FDA, EU Regulations to ensure changes to process/product, quality system documents follow procedures and remain compliant to regulations and standards