Sr. Manager, Systems and Simulation Engineering

Getinge•Wayne, NJ

1d•$190,000 - $215,000•Hybrid

About The Position

Provides leadership and direction for the Systems Engineering and Simulation Engineering functions within R&D. Responsible for system architecture, requirements management, model-based systems engineering (MBSE), system integration, simulation-driven design, verification, validation, and risk management activities supporting the development of innovative medical devices. Leads multidisciplinary teams to ensure the delivery of safe, effective, and compliant products that meet customer, clinical, regulatory, and business requirements. Drives the adoption of simulation technologies, digital engineering practices, and systems-based methodologies to improve product quality, development efficiency, and technical decision-making throughout the product lifecycle.

Requirements

Bachelor's degree in Engineering, Systems Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Computer Engineering, or a related technical field; Master's degree preferred.
10+ years of progressive engineering experience, including at least 5 years of engineering leadership or people management experience.
Demonstrated experience in systems engineering, product development, and system integration within a regulated industry.
Experience applying systems engineering methodologies, requirements management, risk management, and verification/validation processes.
Experience with computational modeling, simulation, digital engineering, or model-based development tools.
Medical device development experience is strongly preferred, particularly in cardiovascular, critical care, or life-support technologies.
Experience working within FDA, ISO 13485, CE Mark, and other regulated product development environments.
Strong expertise in Systems Engineering principles and product development processes.
Knowledge of Model-Based Systems Engineering (MBSE) methodologies, FEA and requirements management tools.
Experience with engineering simulation techniques, including multiphysics, fluid dynamics, thermal, structural, control systems, or related analytical methods.
Strong understanding of system architecture, integration, verification, validation, and risk management practices.
Knowledge of applicable standards, including FDA regulations, ISO 13485, IEC 60601, IEC 62304, and ISO 14971.
Demonstrated leadership, talent development, project management, and organizational capabilities.
Strong analytical and problem-solving skills with the ability to influence technical decision-making across disciplines.
Excellent communication, negotiation, presentation, and stakeholder management skills.
Ability to effectively manage multiple priorities in a fast-paced environment

Nice To Haves

Master's degree preferred.

Responsibilities

Lead Systems Engineering and Simulation Engineering teams supporting new product development and technology development programs.
Accountable for system-level engineering deliverables including requirements, architecture, modeling, simulation, integration, Human Factors, pre-clinical, verification, and validation activities.
Establish and maintain system architectures, functional decompositions, and interface definitions for complex medical device platforms.
Drive requirements engineering processes, ensuring complete traceability between user needs, design inputs, subsystem requirements, and verification evidence.
Lead the application of model-based systems engineering (MBSE) methodologies and digital engineering practices across development programs.
Oversee the development and validation of computational models and simulations used for system performance prediction, design optimization, and risk reduction.
Direct system integration activities and resolve complex cross-functional technical issues involving mechanical, electrical, software, controls, and disposables engineering disciplines.
Lead system-level risk management activities in accordance with ISO 14971 and company procedures.
Ensure simulation tools, methodologies, and models are appropriately validated and applied to support engineering and regulatory decision-making.
Drive system verification and validation strategies to demonstrate compliance with customer, clinical, regulatory, and quality requirements.
Serve as technical leader and subject matter expert for systems engineering and simulation-related activities across R&D programs.
Collaborate with clinical, regulatory, quality, manufacturing, marketing, and service organizations to ensure successful product development and commercialization.
Support regulatory submissions, technical reviews, audits, and inspections by providing systems engineering and simulation-related documentation and rationale.
Recruit, develop, mentor, and retain high-performing engineering talent while fostering a culture of innovation, collaboration, and continuous improvement.
Identify and execute opportunities to improve engineering processes, tools, methodologies, and organizational capabilities.
Support Human Factors Engineering activities across the product development cycle.