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Spotlight call: Tuesday, October 17th at 10am Central
Call in number:1-415-655-0003 US Toll
Access code: 921 538 889
SUMMARY OF POSITION:
To provide engineering leadership in the design and development of innovative products for Renal Care Solutions through system level evaluation, verification and validation; and provide engineering expertise on cross-functional development project teams and collaborate with other Healthcare and external engineering groups.
• Assess RCS products for the risks of hazardous substances to meet MDR requirements.
• Ensure RCS 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.
• Maintain a BU Hazardous Material database
• 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
• Establish and advocate for best practices and continuous improvement of the Systems Engineering knowledge and processes (CoE)
• 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
• Collaborate with quality and regulatory colleagues to ensure compliance
• Participate in the identification and resolution of complex system issues through interfacing with engineers representing other components
• Collect, analyze, and model design inputs (voice of the customer, voice of the business, etc.) and transform them into high quality stakeholder and system requirements
• Provide engineering review on current research projects, device concepts and data.
• Propose and champion new device concepts
Education / Experience required:
• 6+ years of experience with a Bachelor’s Degree in a technical/engineering discipline; or
• 4+ years of experience with a Master’s Degree in a technical/engineering discipline; or
• 3+ years of experience with a PhD in a technical/engineering discipline
• Conversion of product concepts in product requirements
• Solid understanding of the risk management process
Preferred Skills/ Qualifications:
• Material sciences degree
• Significant breadth of knowledge in Quality, technical expertise, and all areas of product development.
• Knowledge of dialysis device operation
• Knowledge of FDA regulations and TU ¨V requirements
• Knowledge of Healthcare engineering resources/groups and track record of collaboration.
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