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MDR - Quality Engineer
Ref No.: 18-23251
Location: Plymouth, Minnesota

Actual title: Design Quality Engineer
Interventional Lung Solutions
Plymouth, MN

To provide design quality and reliability support for European Medical Device Regulation (EU MDR) assessment of design history file deliverables and risk management remediation / state of the art for Interventional Lung Solutions (ILS) products, provide engineering expertise on cross-functional teams and collaborate with other Healthcare and external engineering groups.

• Strong working knowledge of medical device risk management in compliance with 14971:2012 and Design Controls.
• Strong working knowledge of EU Medical Device Regulations, FDA Guidance Documents and Industry Standards.
• Assess ILS products for the risks of hazardous substances to meet MDR requirements.
• Ensure ILS products meet the environment, packaging, and RoHS regulations. Assess alternative substances, materials or designs and analyze their availability and feasibility to meet the EU regulations.
• Ensure EHS&S requirements are met during Product Development Process and Sustaining Engineering updates
• Ensure through analysis or physical testing the EHS&S requirements are met
• Capability of interrupting regulatory requirements to meet EHS&S international requirements
• Ensure that device concepts meet targeted geographies EHS&S through systematic evaluation of product requirements of the system that acknowledge technical, schedule, and cost constraints.
• Lead, coordinate, execute, and document system analysis and design activities, including but not limited to security, safety, reliability, risk, usability and interface management
• This candidate will have a strong Quality background and must be able to work in a team environment and be able to communicate clearly across all disciplines including Research & Development, Regulatory Affairs, Manufacturing, Marketing and Outside Partners and Regulatory Agencies.
• Generate and approve requirements and specifications for all aspects of product concept; ensure that all systems are developed in harmony and support each other.
• Establish verification and validation plan(s) to ensure EHS&S requirements are met
• Apply established SOP's, and/or develop new processes as needed, to ensure that newly developed devices meet established requirements and, where necessary, are approvable under applicable regulatory requirements
• Assess system performance during the development process and provide feedback to these teams
• Strong collaboration and influence skills (build relationships, leverage others, align and work towards shared outcome-based goals, understand others' needs, negotiate for win-win)

Education required:
Bachelor's Degree or Master's degree in a technical/engineering discipline

• 3+ years of experience with a Bachelor's Degree in a technical/engineering discipline; or
• 1+ years of experience with a Master's Degree in a technical/engineering discipline; or
• Solid understanding of the risk management process

Preferred Skills/ Qualifications:
• Material sciences degree
• 1+ years of experience with a PhD in a technical/engineering discipline
• Significant breadth of knowledge in Quality, technical expertise, and all areas of product development.
• Strong working knowledge of risk management, CAPA, and Design Controls.
• Strong working knowledge of Medical Device Regulations, FDA Guidance Documents and Industry Standards
• Knowledge of Electromagnetic Navigation Bronchoscopy (ENB) device operation or other endobronchial procedures/devices
• Knowledge of FDA regulations and BSI requirements
• Knowledge of Healthcare engineering resources/groups and track record of collaboration.