Sr. Engineer

Defines and analyzes system requirements, clinical workflows, and input/output processes by using current systems engineering methods and technologies. Systems engineering mindset, able to articulate customer unmet needs and translate into holistic technical solutions. Providing technical direction and system-level expertise across development teams working on the design and development of complex medical device systems. Researches, develops, designs, and evaluates: mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment. Develops solutions to diverse engineering problems using ingenuity and creativity. Leverages internal/external partners as necessary to achieve project objectives. Drives technical project tasks within single use device development including requirements, design, implementation, test, integration, transfer to manufacturing, and verification/validation. Solves system problems by analyzing the situation and recommending corrective or alternative actions. Leads technical workstreams through problem solving. Facilitates crisp decision making around key technical issues. Independently plans and organizes project tasks with showing the ability to prioritize tasks, execute, and direct others. Ensure quality system compliance for medical device development, champion continuous improvement, and adopt best practices. Participates in the development of others by providing coaching and guidance. Creates a strong team culture around high expectations and high performance Participates in writing and submission of intellectual property (patents). Maintains detailed documentation throughout all phases of research and development. Provides clear communication to Technical Leaders at key technical updates. BS degree in Mechanical Engineering Required minimum years of work experience (primarily in medical device or related field): 5+ Years with BS, 3+ Years with MS Experience managing technical aspects of projects as a member of a cross-functional core team Demonstrated strong cross-functional collaboration and project/task management enabling highly effective teams Passion for understanding and solving problems for end users Strong written and oral communication skills Proven self-starter who runs towards critical issues, ambiguous requirements, or loosely defined challenges with a demonstrated ability to rally teams to achieve business results. Experience with electrophysiology and/or Class II or Class III Medical Device product development experience. Demonstrated product development leadership and communication skills. Demonstrated ability to provide technical leadership within a large-scale development program Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources. Medical Device experience working with imaging and signal processing systems (EEG, Electrophysiology, etc.). Experience conducting simulations, mathematical analysis and/or system interaction analysis. Engineering experience in mixed HW/SW systems. Technical experience with digital and analog low noise systems. Usability engineering experience. Understanding of working within a quality system, IEC and ISO standards relevant to medical device lifecycle and risk management (i.e., ISO 13485).