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We are looking for a seasoned engineer to join our Systems Engineering department within the Electrophysiology Division at Boston Scientific. The Principal Systems Engineer will be a Systems Engineering technical lead on complex product development projects for the OPAL Mapping System. This person will be responsible for leading the design and development of novel integrated solutions for Boston Scientific's rapidly growing and evolving EP product portfolio.
The Principal Systems Engineer will be a member of a cross-functional core team. Responsibilities of the Principal Systems Engineer include: leading the development of requirements in close collaboration with marketing and internal and external stakeholders, understanding and analyzing clinical workflows, interfacing with/presenting to medical key opinion leaders, generating systems architectural concepts in collaboration with the technical team, leading and providing guidance to an interdisciplinary team of SW/Electrical/Mechanical professionals, planning test method developments, analyzing data, implementing the solutions in hardware and software according to Boston Scientific's product development procedures.
Your responsibilities will include: - You will be responsible for completing system engineering activities, from early phase development to market release. Your key tasks will include:
- Designing or supporting the development of systems architecture aligned with business and customer needs.
- Executing multiple systems engineering activities throughout the product development life cycle.
- Applying critical thinking skills to solve complex systems interaction problems.
- Providing expertise in multiple roles in the product development life cycle, showcasing deep knowledge of system functionality.
- Advising the project management team on key product risk/benefit trade-offs.
- Influencing cross-functional peers to make timely decisions and recommendations for project success.
- Representing the Systems Engineering organization as the prime technical contact for assigned features, tools, or subject matters.
- Providing input for submissions to regulatory bodies and governmental agencies.
- Defining interface requirements between systems and maintaining traceability of requirements documentation.
- Managing changes to interfaces during development and throughout the product lifecycle.
- Ensuring configuration compatibility through the product lifecycle.
Qualifications:
- Bachelor's degree in Engineering and/or Science with 10+ years of experience in developing highly complex systems.
- 7+ years of experience as a Systems Engineer in the medical/diagnostics space, focusing on electromechanical systems.
- Demonstrated working knowledge of systems engineering principles, requirements management, and medical device regulations.
- Ability to lead teams through a structured approach to solving complex technical problems.
- Experience with requirement management, collaboration, and issue tracking tools.
- Experience in product concept development, customer interaction, verification of engineering requirements, and validation of customer needs/design requirements.
- Practical knowledge of project management concepts and experience with Agile concepts including scrums.
- Leadership skills with the capability to make trade-offs between risks, benefits, and performance.
- Understanding and experience in the design, development, and testing of software based medical devices.
- Familiarity with developing Test Methods and Test Equipment.
- Experience with industry-based standards, including testing for safety and EMC according to 60601-1
Preferred Qualifications - Experience with cyber security and IEC 62304.
- Usability engineering experience.
- Electrophysiology knowledge.
- Medical Device experience working with imaging and signal processing systems (EEG, Electrophysiology, etc.).
- Experience conducting simulations, mathematical analysis and/or system interaction analysis.
- At least 6 years of engineering experience in mixed HW/SW systems.
- Technical experience with digital and analog low noise systems.
- Strong written and verbal communication, judgment, decision-making, and critical thinking skills.
- Ability to build strong relationships across the organization and with external stakeholders.
Requisition ID: 630330Minimum Salary: $ 106800 Maximum Salary: $ 202900 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.
