•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
•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
Nice to Have
•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 TÜV requirements
•Knowledge of client engineering resources/groups and track record of collaboration.
“TAJ Technologies, Inc. is an EEO/AA Employer: women, minorities, the disabled and veterans are encouraged to apply”