Additional Location(s): N/A
We are seeking an experienced Senior Systems Test Engineer to join a dynamic, cross-functional team that provides technical leadership across mechanical, electrical, software and catheter engineering disciplines. In this role, you will collaborate with interdisciplinary partners in Marketing, Regulatory Affairs and Quality to support the development and commercialization of innovative electrophysiology technologies.
This position will focus on Design Verification (DV) activities associated with new product development projects from concept through commercialization, as well as support for commercially released products. The successful candidate will partner with project teams to define test strategies, develop and validate test methods, and ensure the successful execution of design verification activities. This role will primarily support the Opal HDX Mapping System and its integrated components.
Your responsibilities will include:
• Plan and execute Design Verification activities for electrophysiology projects and programs.
• Develop and communicate testing schedules, including updates and changes, to cross-functional teams.
• Design, develop, validate and execute test methods to inform design decisions and verify system functionality.
• Author and maintain test procedures, test reports and design verification plans to support regulatory submissions.
• Design and assemble new test fixtures to support verification activities.
• Partner with New Product Development and Quality teams to investigate issues, troubleshoot defects and determine root causes.
• Collaborate with cross-functional engineering teams to support product development from concept through commercialization.
• Support verification activities for the Opal HDX Mapping System and associated integrated technologies.
Qualifications:
Required qualifications:
• Bachelor's degree in electrical engineering, mechanical engineering, computer science, biomedical engineering or a related engineering discipline.
• Minimum of 5 years' experience within the medical device industry with a bachelor's degree, or minimum of 3 years' experience with a master's degree or doctorate.
• Experience leading engineering projects and driving technical tasks to completion.
• Experience conducting simulations, mathematical analyses and/or system interaction analyses.
• Experience working with mixed hardware and software systems.
• Technical experience with digital and analog low-noise systems.
• Experience using Minitab, Linux, MATLAB and Python.
• Strong communication, collaboration and time management skills.
• Demonstrated ability to work independently and apply a solution-oriented approach to problem-solving.
Preferred qualifications:
• Experience supporting electrophysiology, cardiac mapping or related medical device technologies.
• Experience developing and validating test methods in a regulated environment.
• Experience supporting Design Verification activities for complex medical systems.
• Experience preparing technical documentation for regulatory submissions.
• Knowledge of FDA, ISO 13485 and design control requirements.
Work model, sponsorship, relocation:
This position follows an on-site work model and requires employees to work from the designated Boston Scientific office location. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.
Requisition ID: 630521
Minimum Salary: $ 89200
Maximum Salary: $ 169500
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
