Director, Systems Engineering

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About Surgery

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

Are you passionate about improving and expanding the possibilities of surgery Ready to join a team thats reimagining how we heal Our 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 worlds 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 are searching for the best talent for a Director Systems Engineering . This role will be based in Cincinnati OH and will work a Flex/Hybrid schedule. Relocation assistance may be available on a case-by-case basis and if approved by the business.

This leader is responsible for all Lead Systems Engineers owning New Product Development (NPD) and Lifecycle Engineering programs ensuring robust technical solutions multi-functional alignment and delivery of safe effective and innovative medical devices. The role serves as the primary steward of systems engineering best practices driving technical excellence requirements rigor risk management verification and validation and design integration across the full product lifecycle.

Key Responsibilities:

Leadership & Strategy

• Provide strategic direction for systems engineering across product lines ensuring alignment with business goals product roadmaps and platform strategies.
• Lead mentor and develop team of high-performing Lead Systems Engineers. The Lead Systems engineers are responsible for delivering overall technical strategy high-level architecture and integration of complex electromechanical and energy-based medical products. They will collaborate with Functional Engineers from the Hardware Engineering group and Managers from the Product and Portfolio Management group to ensure the product value proposition is delivered per business expectations.
• Shape and execute strategy across the Endomechanical and Energy portfolio
• Establish and champion systems engineering methodologies including model-based systems engineering (MBSE) requirements management design integration and verification strategies.
• Serve as a key technical leader within the R&D organization collaborating with Product and Portfolio Management Hardware and Development Engineering Supply Chain Regulatory Quality and Pre-Clinical leaders to ensure on-time/on-budget delivery of products.
• Drive alignment between R&D and Supply Chain to ensure product scalability and robust design transfer.

Systems Architecture & Technical Ownership

• Accountable for system-level architecture of complex electromechanical and energy-based medical devices ensuring cohesive and scalable design solutions.
• Partner with upstream marketing clinical engineering and Front-End R&D to translate user needs and clinical insights into system requirements.
• Oversee the development and flow-down of system requirements interface specifications risk analyses and verification/validation plans.
• Provide expert technical guidance to resolve system-level tradeoffs integration challenges and design risks.
• Ensure technical consistency and design traceability across subsystems including mechanical electrical firmware software energy delivery and human factors.

Program Execution & Governance

• Own systems engineering support for New Product Development (NPD) programs from concept through commercialization.
• Guide lifecycle engineering efforts including cost-reduction reliability improvement sustaining engineering and post-market design changes.
• DRI for building capabilities talent development and succession planning within the department.
• Own key functional responsibilities of budget management and resource planning for the department.

Continuous Improvement & Innovation

• Establish and maintain best-in-class systems engineering tools processes and templates.
• Drive innovation in system design architecture modularity and platform development.
• Promote a culture of technical and design excellence and data-driven decision-making across the R&D organization.

Qualifications

Education:

• Bachelors degree in Mechanical Engineering Electrical Engineering Systems Engineering Biomedical Engineering or related field.

Experience and Skills:

Required:

• 12 years of R&D experience in medical devices or other high-regulation complex system environments.
• Strong background in electromechanical systems energy-delivery technologies surgical devices or related domains.
• 5 year of direct people leadership.
• Consistent track record to lead a team of individual leaders to achieve business goals.
• Deep expertise in systems engineering principles including requirements development design integration risk management and design controls.
• Experience leading NPD programs from concept through launch and Life Cycle Engineering teams.
• Thorough knowledge of systems engineering practices for electromechanical products.
• Demonstrated willingness to proactively take on technical leadership and own ambiguous and challenging issues.
• Demonstrated ability to think analytically solve problems and influence decision makers across the organization.
• Thrive in a fast-paced constantly evolving environment with multiple priorities.
• Outstanding written oral and presentation communications skills for use within the team and for communicating with partners and leadership.
• Ability to work effectively in a large complex team with members of varied backgrounds and levels of experience.

Preferred:

• Experience developing medical devices within FDA ISO and IEC requirements and guidelines including risk analysis and quality assurance.
• Demonstrated success improving engineering processes and organizational capability.
• Certifications: Project Management (e.g. PMP or equivalent)/ Lean Six Sigma Green Belt or Black Belt/ Systems Engineering certification (e.g. INCOSE ASEP CSEP or ESEP).

Other:

• Travel less than 25 % domestic and international.

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 & 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 contact us via or contact AskGS to be directed to your accommodation resource.

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