R&D Systems Engineer III - Electrophysiology

R&D Systems Engineer III - Electrophysiology

Work mode: Onsite

Onsite Location(s): Arden Hills, MN, US, 55112

Additional Location(s): N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information, and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.

About the Role

The Ablation Catheter Development Team is growing and has an exciting opportunity for a Systems Engineer III role supporting Electrophysiology product development within the Cardiology division. Electrophysiology is an exciting growth driver for BSC. With the acquisition of FARAPULSE Inc., Boston Scientific will strengthen its leadership in Personalized EP Solutions, with a strong focus in Atrial Fibrillation.

This role will be a key team member in providing systems engineering support in the creation and development of new electrophysiology ablation catheter technologies and the integration of those products into the larger system. As a R&D Systems Engineer III, you will support new product development team solutions to multi-faceted customer issues.

You will be a part of a high-performance team responsible for the design, implementation, and test of medical devices within our electrophysiology pulsed field ablation device portfolio. This critical role will be a part of best-in-class development practices and rigorous, holistic product design in coordination with internal and external partners.

Your Responsibilities Will Include:

• Researches, develops, designs, and evaluates: mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment.
• Demonstrates a basic understanding of problem-solving processes and tools to assist in root cause analysis of complex engineering problems. Gathers and communicates information to help identify/solve problems.
• Approaches problems analytically, methodically, and systematically.
• Leverages internal/external partners as necessary to achieve project objectives.
• Demonstrates a basic understanding of technical aspects of complex device development including requirements, design, implementation, test, integration, transfer to manufacturing, and verification/validation.
• Translates user needs to create technical requirements aligned to design through the development cycle toward successful execution of usability and validation plans toward regulatory submission and approval.
• Understands, evaluates, and shares clinical practice and expectation that drive design and test to improve product integration and usability.
• Learns and performs the basics of data collection, organization, and preliminary analysis. Demonstrates basic knowledge of analytical techniques and tools.
• Understands basic test methods, work instructions, protocols, and executes accordingly.
• Solves system problems by analyzing the situation and recommending corrective or alternative actions. Facilitates crisp decision making around key technical issues.
• Plans and organizes project assignments of substantial variety and complexity. Provides clear communication to project leads or mentors.
• Ensures quality system compliance for medical device development, champion continuous improvement, and adopt best practices.
• Creates a strong team culture around high expectations and high performance.
• Maintains detailed documentation throughout all phases of research and development.

Required Qualifications:

• BS degree in Mechanical, Electrical, Biomedical, or Systems Engineering
• Required minimum work experience: 3+ Years with BS, 2+ Years with MS
• Experience with Design/Technical skills in complex electromechanical systems with the ability to demonstrate a good understanding of the fundamentals of Design.
• Experience working with Electrophysiology and/or Class II or Class III Medical Device products.
• Experience working within a quality system, IEC and ISO standards relevant to medical device lifecycle and risk management (i.e., ISO 13485).
• Passion for understanding and solving problems for end users
• Demonstrates strong cross-functional collaboration and project/task management enabling highly effective teams.

Preferred Qualifications:

• Takes initiative, has a motivation to learn and shows willingness to ask questions.
• Strong written and oral communication skills
• Passion for understanding and solving problems for end users.
• 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.
• 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.