At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com

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About Surgery

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of MedTech surgery? Ready to join a team that’s reimagining how we heal? Our MedTech Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at https: //www.jnj.com/medtech.

We are searching for the best talent for a Senior Manager, Systems Engineering position, to be located in Cincinnati, OH.

Job Description:

The Sr. Manager, Systems Engineering will structure, recruit, develop and lead a team that will drive the definition, design, development, and verification & validation of complex capital systems. This individual will be a key member of the Capital Systems organization, making vital contributions to the New Product Development (NPD) pipeline and transform patient care through innovation.

With this mission in mind, we are looking for a collaborative and self-motivated Sr. Manager, Systems Engineering to lead the Systems Engineering efforts of complex capital products involving multiple subsystems, a wide range of cutting-edge technologies and solution partners.

You will be responsible for:

• Lead the requirements definition and architecture for software and electrical designs of highly complex medical capital products.
• Partner with marketing, product leadership, design. Manufacturing, quality, and verification teams to translate high-level customer needs into technical options while analyzing trade-offs and business impact
• Maximize reuse of requirements across family products in collaboration with global stakeholders.
• Orchestrate data and system architecture efforts in collaboration with subsystem leads and solution partners.
• Lead risk management activities to plan, analyze and control design and use related risks.
• Create and maintain traceability among design input, design output, verification and validation, and risk management artifacts to ensure completeness and fully traceable design history file.
• Lead integration of subsystems in accordance with program requirements and architecture.
• Lead initiatives to identify, prioritize, define, and implement improvements to systems engineering processes to achieve best-in-class quality and reliability.
• Plan and execute the department strategy to meet goals and expectations; gathers information, frames problems, devises/executes plans, tracks progress, and adjusts/measures success within scope of responsibility to improve development efforts as well as the organization.
• Applies an expert understanding of systems to serve as a subject matter expert for the development team regarding behaviors, implementation trade-offs, satisfaction of customer needs, clinical applications, and the applicable technologies required to solve problems and deliver upon business objectives.
• Develop Systems Engineering multi-site staff to serve on programs in line with departmental vision. Ensures their success by reviewing and advising on technical strategy, key system-level technical activities, work output and processes.
• Use Scaled Agile Framework for Systems Engineering activities.
• Foster collaboration with cross-functional teams and other leaders to drive work to completion and resolve issues. Successfully influences stakeholders. Communicates effectively with cross-functional teams and senior management.
• Establish and maintain internal and external partnerships to leverage specialized engineering support and maintain cross functional alignment.
  

Qualifications / Requirements:

Education:

• Bachelor’s degree in Engineering. Master’s degree in engineering, or MBA, preferred.
• 8+ years of practicing engineering experience with progressive responsibility to develop the competence required to meet the skills and responsibilities of the position (or 6 years’ experience with advanced degree).
  

Minimum Requirements:

• Broad and proven background in leading systems engineering teams focused on multiple and complex project design and development initiatives.
• Ability to motivate and lead a diverse staff to drive the execution of critical strategies and programs across a large organization.
• Ability to accurately evaluate and assess complex processes; identify possible solutions and drive to resolution.
• Demonstrated skills in developing and introducing innovative FDA regulated medical devices (Class 1, 2 or 3).
• Proficient with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls).
• Experience supporting definition of regulatory strategies and implementation in direct communication with internal stakeholders and regulatory bodies.
• Ability to moderate requirements engineering discussions and work as a bridge among different engineering departments and stakeholders, translating customer pain points into efficient technology based solutions.
• Experience architecting and allocating requirements across multiple subsystems.
• Experience with a wide range of medical device risk analysis techniques and risk management deliverables
• Experience writing verification plans, protocols and reports according to medical device regulations.
• Experience with safety-critical and electro-mechanical medical device technologies.
• Experience leading selection, deployment and use of enterprise requirements and test management systems.
• Ability to form and develop interpersonal, professional and collaborative relationships; displays socially and professionally appropriate behavior.
  

Preferred Skills & Experience:

• Experience writing Use cases, creating Storyboards and using Voice-of-Customer (VOC) techniques to facilitate requirements gathering efforts (Interviews, Surveys, KJ Analysis, CTQ, AHP, Kano Analysis and Critical Parameter management.
• Experience in Reliability Engineering practices such as reliability modeling, prediction, HALT and HASS.
• Demonstrated skills in developing and introducing innovative FDA regulated medical devices.
• Experience managing globally distributed teams, consultants and contractors.

Other Requirements:

• Ability to travel as necessary to meet organizational goals.
  

This job posting is anticipated to close on 6/26/25. The Company may however extend this time-period, in which case the posting will remain available on https: //www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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