Senior Manager Systems Engineering

About the position

This is a critical management role in BSC Neuromodulation R&D, within the Systems Engineering function. The Sr. Manager will lead a high performing team responsible for design, test and verification of connected systems including implantable medical devices, externalized HW, data transfer to/from servers, peripheral devices & the display of valuable information to customers. This role is highly cross-functional both inside and outside of R&D, and interfaces with a global team of R&D engineers. Team members work across the organization, often serving as a primary technical point of contact for program management, marketing, regulatory, technical services, reliability and clinical functions. Team members also support multiple programs in the Technology Development (TDP), Product Development (PDP) and Sustaining phases for the Neuromodulation business. 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.

Requirements

• Bachelor's degree or 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.

Nice-to-haves

• 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.

Benefits

• Base Salary Range Minimum Salary: $127900
• Base Salary Range Maximum Salary: $243000
• Variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).