Principal R&D Systems Engineer - Electrophysiology at Boston Scientific Corporation Malaysia

Arden Hills, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Mar, 26

Salary

0.0

Posted On

06 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Electrophysiology, Mechanical Engineering, Electromechanical Systems, Project Management, Cross-Functional Collaboration, Quality System Compliance, Regulatory Submission, Problem Solving, Technical Leadership, Usability Testing, Design Requirements, Documentation, Continuous Improvement, Training and Development, Risk Management, Systems Engineering

Industry

Medical Equipment Manufacturing

Description

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 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 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, Electrical, Biomedical, or Systems Engineering Required minimum years of work experience (primarily in medical device or related field): 7+ Years with BS, 5+ 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 managing technical aspects of projects as a member of a cross-functional core team Demonstrated strong cross-functional collaboration, influence without authority, and project/task management enabling highly effective teams 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 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. 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.

Responsibilities

The Principal R&D Systems Engineer will research, develop, design, and evaluate mechanical and electro-mechanical systems, driving technical aspects of complex device development. They will lead technical teams, ensure compliance with quality systems, and maintain detailed documentation throughout the R&D phases.