Senior Systems Engineer - Electrophysiology

at  Boston Scientific Corporation

Job Description

REQUIRED QUALIFICATIONS:

• Bachelor or Masters of Electrical, Biomedical, Mechanical or Firmware Engineering, or equivalent.
• 4+ years of experience with product development activities in a regulated industry.
• Experience in Systems Engineering and Systems Verification activities.
• Experience with authoring and analyzing requirements.
• Experience in troubleshooting test failures.
• Strong problem-solving skills in a team environment.
• Excellent organizational, communication and collaboration skills.
• Understanding of hardware design and trade-offs, embedded (real-time) software tradeoffs, performance, and redundancy issues.

PREFERRED QUALIFICATIONS:

• At least 4 years of experience leading product development teams in a Medical Regulated Environment.
• Experience in performing FDA Medical Device Submissions
• Experience in performing EU MDR Medical Device Submissions
• Experience in performing Japan Medical Device Submissions
• Understanding of signal processing.
• Experience in working on medical devices used in electrophysiology such as therapy or diagnostic devices (ablation and mapping systems).
• Strong knowledge of ISO 13485 and FDA 21 CFR Part 820.
• Knowledge of ISO 14971.
• Demonstrated ability to interact with and influence key stakeholders both internal and external to the organization.

ABOUT THE ROLE

The Senior R&D Systems Engineer will work alongside the R&D team to iterate on existing commercial products and perform new product development activities. The Senior R&D Systems Engineer will develop system architectures and translate user needs into detailed sub-system requirements throughout the product development lifecycle. You will contribute to process improvements (customer experience, manufacturing and servicing), conduct risk assessments, and support regulatory submissions, ensuring compliance with industry standards. This role involves close collaboration with cross-functional teams to evaluate and validate systems, drawing on your deep understanding of hardware, software/firmware, and systems engineering.

YOUR RESPONSIBILITIES WILL INCLUDE:

• Participate in developing system architectures for existing and new product developments.
• Assess feasibility of new technologies prior to a new product development project through research, bench studies and pre-clinical evaluation.
• Participates on project teams to translate user needs into design requirements (e.g. system, hardware, software, firmware, mechanical, electrical, interface, etc.) consisting of system/sub-system specifications.
• Manage system/sub-system requirements and generate requirements traceability.
• Contributes to product risk assessment activities and perform Design FMEA’s activities.
• Assists Regulatory with product submissions.
• Provides expertise and helps evaluate the required validation and verification activities in a given project.
• Performs systems engineering in compliance with Basic Safety & Electromagnetic Compatibility according to 60601-1 (Basic Safety for Medical Devices)
• Works with a cross-functional team and serves as an R&D representative on cross-functional deliverables.
• Continuously improve processes and work methodologies (using agile/lean principles to eliminate waste) to help solve complex, interdisciplinary problems by interfacing with peers/cross-functional groups.