Norwood, United States
10 months ago
Using Systems Engineering procedures standard to research and development, carries out assignments associated with research, design, or development, and the manufacturing of specific parts and components of medical diagnostic systems.
Perform advanced system engineering tasks for an electromechanical point-of-care medical device, including systems architecture development, requirements, interfaces, systems engineering processes.
Provide input into medical device and future device iterations - develop concepts and requirements documents.
Enhance requirements communication between teams engaged in the engineering and acquisition functions. Develop and implement new processes as appropriate. Create and maintain major program documents, such as Systems Engineering Plans
Lead the development of new requirements for medical device systems, focusing on how medical systems are designed, manufactured, and tested.
Involved with program integration such as organizing integrated product team meetings, systems reviews, and interagency discussions and documentation creation.
Execute processes to ensure baseline control and provide leadership to the Configuration Management, Data Management, and Data Architecture teams.
Key Accountabilities: Leads and manages the Risk Management File for Blood Gas Systems
Leads FMECA, FTA, traceability activities, requirements refinement activities across Blood Gas Systems.
Provides input to metrics for each project within the program to monitor development time to aid in the creation of predictable schedules.
Participates in and/or challenges designs, tolerance studies, change requests, procedures, test methods, protocols and reports and assists in resolution of conflicting design requirements.
Authors and/or reviews project sub-plans, requirements, risk management.
Adheres to Systems Engineering and design control processes.
Skills & Capabilities:
Adapts to change quickly and is able to multi-task, managing several activities or projects simultaneously.
Demonstrates proficiency in performing root cause analysis and initiating and leading troubleshooting activities.
Demonstrates strong development, management and leadership skills with the ability to think independently.
Demonstrates technical confidence to interact with engineers of other disciplines, supports technical discussions, and demonstrates the ability to make technical decisions Ability to produce quality written work, such as, technical reports, protocol and plans. Ability to skillfully present work and communicate ideas effectively to a multi-disciplinary teams.
Ability to understand complex system interactions and the effect on analytical performance.
Qualifications Min Knowledge & Experience required for the position: B.A./B.S. with a minimum 8 years of experience or M.S. with 6 years of experience or equivalent combination of education and experience in Engineering, Science or related field, (Biology, Chemistry, Physics, Biotechnology, Biomedical, Electrical, Mechanical, Chemical Engineering). In-vitro medical device experience highly desired. Demonstrates strong knowledge of ISO 14971, ISO and FDA design control requirements
Experience with the following tools/methods higher desired: Six Sigma, DOE, Failure Analysis, FMEA, Minitab, Lab View, MathCAD, MathLAB, Word, Power Point, Excel, IBM DOORS.
Knowledge of Systems Engineering theories and practices with the ability to effectively incorporate these practices.