Boston Scientific Principal Systems Engineer - Cardiac Diagnostics 

United States, Minnesota, Arden Hills 

255643402

Your responsibilities will include:

• Designs, defines, implements system requirements, system specifications, input/output processes and working parameters by using current systems engineering methods and technologies
• Documents system requirements by writing documents, reports, memos, change requests according to approved procedures and standards
• Solves system challenges/opportunities by considering inputs and collaborating with technical and cross-functional colleagues to find optimal solutions
• Coordinates, manages, and documents project goals/progress and recommends appropriate revisions
• Leads medical device hardware development in the context of a system, considering device firmware and other software components
• Continuously improves process and work methodologies by interfacing with peers/cross-functional groups and analyzing activities to improve workflow and work processes
• Works independently on highly specialized projects with long range objectives
• Directs project activities and provides guidance to other engineers on the team, leveraging rich domain knowledge

Required qualifications:

• Minimum of a bachelor’s degree or higher in engineering (Mechanical Engineering, Electrical Engineering, or Biomedical Engineering preferred)
• Minimum of 8 years of experience (6 years with Master’s degree) designing and documenting technical systems in a highly regulated industry (medical device preferred)
• Is acknowledged as a subject matter expert in a relevant technical field and influences broader team of technical experts
• Experience with supplier interaction / vendor management
• Strong technical writing skills to facilitate generation of project-related documentation
• Demonstrated project management experience
• In-depth knowledge of device Design History File and Risk Management content creation

Preferred qualifications:

• Advanced degree in Engineering
• Experience designing small battery-powered medical devices
• Experience coordinating regulatory standards pre-testing and formal testing with a test laboratory (for example, IEC 60601-1)
• Experience implementing improvements to and optimizing Quality System documentation workflow
• Boston Scientific experience

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement/ The foal of the drug testing is to increase workplace safety in compliance with the applicable law.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.