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Quality Engineer
Ref No.: 18-11245
Location: Plymouth, Minnesota
Start Date / End Date: 09/24/2018 to 09/24/2019
Need local candidates to sit on site in Plymouth, MN.

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

SUMMARY OF POSITION:
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.
ESSENTIAL FUNCTIONS:

• 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


Experience:
• 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.