Boston Scientific Senior Manager Systems Engineering 

United States, California, Santa Clarita 

40413373

Neuromodulation Division

Valencia, CA

The Systems Engineering team’s primary activities are to help define innovative & high valued products for the business, create system requirements & design, partner with various R&D functions to develop these products, and perform system evaluation activities (test development & verification) to ensure high quality. Throughout this process, the Senior Systems Engineering Manager oversees the efficient, high-quality design and evaluation of these products. This manager also devotes a significant portion of time to managerial, leadership & staff development activities and balances this with program accountability.

Responsibilities

• Directly manages a team of full-time employees spanning a broad range of engineering levels as well as non-exempt employees.
• Provides direction & guidance to team members who exercise significant latitude & independence in assignments.
• Builds strategic internal & external partnerships to further departmental & business goals.
• Works collaboratively with Quality & Regulatory functions to ensure product approval & compliance with company & regulatory body policies (Ex. FDA, MDR, etc.).
• Ensures robust system engineering processes, organizational policies & operational plans to achieve department goals.
• Drives functional & technical excellence in Systems for Technology & Product Development.
• Recruits, coaches, trains & develops Systems organizational talent.
• Fosters a diverse workplace so all participants contribute to their full potential in pursuit of organizational objectives.
• Responsible for developing, monitoring & adjusting resource allocations, budgets & schedules across multiple programs for the department.
• Collaborates with other managers/groups to assign tasks & schedule work to achieve project deliverables on time.
• Provides estimates, metrics, reports & updates on projects to Program Management & R&D.
• Helps manage/oversee systems requirements, architecture, tracing, characterizations, algorithm implementations, test architecture, test infrastructure & development, test eqp, system verification, security and risk assessments for software & hardware systems.
• Oversees development of verification strategies, test plans & provides guidance to test engineers in their implementation.
• Ensures deep understanding of customer needs during the design & evaluation process.
• Participates in & presents at department level meetings.

Minimum Required Qualifications

• Bachelor’s degreeor more from an accredited school in Electrical Engineering, Computer Engineering, Electromechanical Engineering, Systems Engineering, Computer Science or related field
• 12+ years in Engineering. MS with 10+ years preferred.
• 10+ years of experience developing complex systems.
• 4+ years of experience managing engineering teams in the development of medical device hardware & software systems.

Preferred Qualifications

• Successful history of launching & sustaining medical product systems spanning HW & SW technologies.
• Experience managing, collaborating with & leading global cross-functional teams.
• Demonstrated ability to direct & control the activities, budget & headcount of an engineering function across multiple competing programs.
• Demonstrated ability to succeed in a fast-paced environment while managing multiple programs simultaneously.
• Understanding of Systems deliverables in the Technology & Product Development phases.
• Experience with Design Controls (user needs, requirements, architecture & traceability).
• Experience with test development (protocols, scripting, infrastructure, automation & eqp).
• Experience with data privacy & cybersecurity for connected product systems.
• Knowledge of industry standard systems engineering methods & tools.
• Knowledge of the medical SW lifecycle process following IEC 62304 as well as SaMD & SiMD.
• Experience with data analysis & advanced statistics including T-Test, ANOVA, Design of Experiments (DOEs), population analysis techniques, probability, 6 Sigma, etc.
• Expertise with test method development, Gage R&R and establishing performance metrics.
• Experience with Lean/Agile concepts including scrum, burndown, backlog & minimizing WIP.
• Black Belt Certification in Lean Sigma, Six Sigma, DRM, Design for X (DFM, DFR, DfSS, etc.).
• Experience supporting HW/SW System regulatory submissions including FDA 510(k) & PMA.
• Project Management training and/or direct experience.
• Experience leading change management initiatives.
• Strong communication skills, including technical discussions at all levels.

Base Salary Range

Minimum Salary: $ 127900

Maximum Salary: $ 243000

Compensation for
exempt rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

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.

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