Principal R&D Engineer - Electrophysiology

Researches, develops, designs, and evaluates: mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment. Develops solutions to diverse engineering problems of high complexity which require the regular use of ingenuity and creativity. Leverages internal/external partners as necessary to achieve project objectives. Drives technical aspects of complex 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 teams through problem solving. Facilitates crisp decision making around key technical issues. Plans and organizes project assignments of substantial variety and complexity. Directs support personnel and project activities. Ensure quality system compliance for medical device development, champion continuous improvement, and adopt best practices. Participates in the development of others by facilitating training and providing feedback and guidance. Creates a strong team culture around high expectations and high performance Writes and submits intellectual property (patents). Maintains detailed documentation throughout all phases of research and development. Provides clear communication to stakeholders at key technical updates. BS degree in Mechanical Engineering Required minimum years of work experience (primarily in medical device or related field): 7+ Years with BS, 5+ Years with Experience managing technical aspects of projects as a member of a cross-functional core team 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 on a large-scale development program Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources. Systems engineering mindset, able to articulate customer unmet needs and translate into holistic technical solutions. Understanding of working within a quality system, IEC and ISO standards relevant to medical device lifecycle and risk management (i.e., ISO 13485).