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Role Summary: This position has design responsibility to deliver customer workflow, feature functionality, product quality, reliability, serviceability, manufacturability, regulatory, compliance, and cost for our Anesthesia and Respiratory Care products. Activities include requirements development, traceability and flow down, architecture / system design and analysis, FMEA, developing/executing System Verification and Validation test procedures, and providing support to manufacturing and field issues.
Essential Responsibilities: Duties include (but are not limited to): • Execution of Risk Management procedures, leading to compliant and effective mitigation of product risks • Ensuring product designs are compliant to relevant international standards • Development and execution of requirements management strategies that minimize overhead while ensuring high-quality documentation • Owning development of product features from solicitation of customer input through design decomposition, verification, and validation • Development of product architecture and design decomposition (including subsystem interface definition) with an emphasis on platforming, re-use, and reliability • Managing systems integration strategy and execution throughout the program lifecycle • Overseeing and executing design verification, including verification planning, procedure writing and execution, and reporting of verification results • Oversight of Defect Management ensuring compliant DRB assessments and appropriate risk-based decisions on the resolution and classification of SPRs • Coordination of the implementation of product stewardship initiatives (such as ROHS, REACH, etc) • Implementation of system-level Design for Reliability practices • Development of Usability File including, but not limited to, user profiles, use environment, usability requirements, formative testing, and summative testing
Qualifications/Requirements: • Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, Computer), Computer Science or similar technical discipline OR Associate’s degree with 5 years of technical experience • Demonstrated competency in understanding functionality of complex systems including mechanical (pneumatic and structural), electrical, and software designs and their integrated interactions • Demonstrated experience working with a multi-discipline, global team • Demonstrated oral and written communication skills • Strong Microsoft Office skills (especially Excel)
Desired Characteristics: • Experience in risk management of medical devices including creation and maintenance of risk management files • Experience in medical device complaint handling and engineering investigation • Experience in design engineering for Anesthesia Systems, Critical Care Ventilators, or other life support devices • Experience in design verification of complex systems • Experience in medical device standards and regulations • Experience with requirements management tools such as DOORs • Experience with defect management tools such as ClearQuest • Experience in systems architecture and integration for complex systems • Experience in design engineering for medical devices • Master’s degree in a technical field • Excellent organizational skills • Ability to work in a high paced, dynamic, global environment • Six Sigma Green Belt, DMAIC and DFSS
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