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Senior R&D Engineer
2 months ago
About the Role:
We are seeking a highly skilled Senior R&D Engineer to join our Electrophysiology Product Development team at Boston Scientific. As a key member of our team, you will be responsible for providing mechanical engineering support in the creation and development of new electrophysiology ablation catheter technologies with a systems engineering mindset.
Key Responsibilities:
- Define and analyze system requirements, clinical workflows, and input/output processes using current systems engineering methods and technologies.
- Apply a systems engineering mindset to articulate customer unmet needs and translate them into holistic technical solutions.
- Provide technical direction and system-level expertise across development teams working on the design and development of complex medical device systems.
- Research, develop, design, and evaluate mechanical and electro-mechanical materials, components, assemblies, processes, and/or equipment.
- Develop solutions to diverse engineering problems using ingenuity and creativity, leveraging internal/external partners as necessary to achieve project objectives.
- Drive technical project tasks within single-use device development, including requirements, design, implementation, test, integration, transfer to manufacturing, and verification/validation.
- Solve system problems by analyzing the situation and recommending corrective or alternative actions, leading technical workstreams through problem-solving and facilitating crisp decision-making around key technical issues.
- Independently plan and organize project tasks, prioritizing tasks, executing, and directing others.
- Ensure quality system compliance for medical device development, championing continuous improvement and adopting best practices.
- Participate in the development of others by providing coaching and guidance.
- Create a strong team culture around high expectations and high performance.
- Participate in writing and submission of intellectual property (patents).
- Maintain detailed documentation throughout all phases of research and development.
- Provide clear communication to Technical Leaders at key technical updates.
Requirements:
- 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.
Preferred Qualifications:
- 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).