Sr. Manager, Systems and Simulation Engineering

Getinge; Wayne (NJ); On-site; USD 190,000 - 215,000; Full time

Benefits offered by this job

Health, Dental, and Vision insurance

401k plan with company match

Paid Time Off

Tuition Reimbursement

Parental and Caregiver Leave

Commuter Benefits

Job summary

Getinge is seeking a Senior leader to provide direction for Systems Engineering and Simulation Engineering within R&D, ensuring architecture, requirements, MBSE, simulation, and verification align with customer, clinical, and regulatory needs.

You will drive cross-functional collaboration to deliver safe, compliant products, lead risk management per ISO 14971, and advance digital engineering across the lifecycle.

Qualifications

• Bachelor's degree in engineering or related field.
• 5+ years in engineering leadership or people management.
• Experience in systems engineering, product development, and system integration in a regulated industry.
• Experience with MBSE, modeling, simulation, and verification/validation processes.

Responsibilities

• Lead Systems Engineering and Simulation Engineering teams for new product development and technology programs.
• Own system-level deliverables: requirements, architecture, modeling, simulation, verification, validation, and risk management.
• Drive MBSE methodologies and digital engineering across programs.

Skills

Systems Engineering

MBSE

Requirements management

Risk management

Modeling & simulation

Medical device development

FDA/ISO experience

Education

Bachelor's degree in Engineering or related field

Master's degree preferred

Tools

FEA tools

MBSE tools

Simulation software

Job description

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

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.

Job Responsibilities And Essential Duties

• 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.

Minimum 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.

Required Knowledge, Skills And Abilities

• 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.

Salary range: $190 - $215k; Target bonus: 25%

About Us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Benefits At Getinge

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.