Principal Engineer Continuous Improvement

2162-Janssen Ortho Legal Entity•Guaynabo, PR

5d•Onsite

About The Position

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 jnj.com. 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. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. 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 Principal Engineer Continuous Improvement to be located in Guaynabo, PR. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. The MedTech Supply Chain Quality Excellence Principal Engineer, Continuous Improvement will lead the implementation of Quality Excellence programs and transformation initiatives across MedTech Quality to drive growth, delivery, quality, and cost improvements. This role is responsible for developing and executing integrated transformation roadmaps aligned to the MedTech transformation framework and playbook, including process simplification, procedures optimization, introduction of new capabilities and tools, and adoption of new ways of working across multiple sites, franchises, and functions. The role interfaces with cross-functional stakeholders to coordinate and execute internal and external improvement opportunities, translating customer and stakeholder insights into scalable solutions through internal/external benchmarking and best-practice adoption. The role leads end-to-end execution to achieve target outcomes, including chartering, metrics identification, detailed planning and milestones, risk identification and mitigation, and change management and communications. The Principal Engineer manages all aspects of successful global program and portfolio delivery, including identification and de-risking of commitments, issue resolution, governance, and performance management (deliverables, efficiency, and financials). In addition to leading transformation initiatives leveraging Process Excellence (PEx) methodologies, the role drives simplification, incoming, micro & chemical testing optimization, technology enablement, own equipment lifecycle, equipment digital readiness of the laboratory areas, test method validation process, digitalization and capability enablement efforts, builds business cases and investment proposals, and coach local teams to adopt new practices and develop skills that sustain improvements over time. This role will foster a Continuous Improvement Culture in the Med Tech Organization.

Requirements

A minimum of a bachelor’s degree in engineering or relevant scientific/technical field and 6+ years of proven experience in engineering, quality, transformation programs, and/or operational excellence in a regulated industry.
Experience leading process optimization, simplification, and/or technology enablement initiatives (including roadmap development, value identification, and execution) with cross-functional, diverse, global teams using PEx methodologies.
Experience with equipment and/or software validation, quality engineering, and/or technology-enabled process changes in the regulated healthcare industry (or similarly regulated environment).
Demonstrated experience in effective project/program management, including business case development and investment/portfolio management.
Strong communication, stakeholder management, and change management skills, with the ability to zoom-in and zoom-out between strategic and tactical activities in a fast-paced global environment.
Proficient technical writing and documentation skills.
Thorough understanding of technology enablement, technology planning processes, software methodologies, and tools (preferred), and ability to translate requirements into fit-for-purpose solutions.
Demonstrated program/project management capability; FPX or PMP certification highly desirable; Agile experience/certification highly desirable.
Process Excellence capability (e.g., PEx certification; Black Belt highly desirable) and a track record of delivering outcome-based/value-driven improvements.
Ability to work autonomously with some ambiguity, manage multiple priorities, and influence stakeholders across segments and regions.
Strong negotiation, communication, and change management skills; proven success building partnerships and leading cross-functional teams.
Equipment and/or software validation experience preferred; fluent verbal and written English communication skills (additional languages advantageous).

Nice To Haves

FPX or PMP certification highly desirable
Agile experience/certification highly desirable
PEx certification; Black Belt highly desirable
Equipment and/or software validation experience preferred
additional languages advantageous

Responsibilities

Led multiple global cross site, cross business unit continuous improvement projects to drive simplification, complexity removal across Med Tech.
Develops integrated transformation roadmaps aligned with the MedTech transformation framework and playbook for Continuous Improvement & Automation and Digitalization.
Identifies process optimization, simplification, and technology opportunities that advance transformation maturity and deliver measurable business value.
Leads current-state assessments (e.g., mapping workshops) and benchmarking to surface efficiencies and best practices, translating insights into scalable solutions.
Builds business cases and investment proposals for transformation initiatives, including process and technology enablement solutions.
Leads cross-functional alignment on prioritization and execution plans for transformation initiatives, including process simplification, automation/digital and capability enablement.
Leads & coordinates all aspects of workstream roadmaps across sites, including scope, schedule, milestones, and delivery management, until the road map closure for Continuous Improvement & Automation and Digitalization.
Manages global portfolios to track and monitor performance measures (deliverables, efficiency, and financials) and to drive transparency and accountability.
Leads budget and planning cycles (LRFP, JU, BP, NU) to align investments with business needs and priorities.
Stablish governance process for testing optimization (RM, In-process, Finish good)
Stablish Ownership process for testing, sampling and AQL optimization (RM, In-process, Finish good)
Led, drive the implementation of global CI projects from the chartering until implementation across different sites, and business units.
Led governance process for Performance Portfolio to ensure delivery of performance KPIs related to simplification, automation & digital across multiple sites and stakeholders.
Led Financial Investment (LRFP, JU, BP, NU) governance Portfolio to ensure delivery of target investment, per business, sites and CARs.
Establishes and participates in program governance, providing regular updates on progress, risks, decisions, and communications.
Develops and executes stakeholder change management and communication plans to enable adoption and sustainment.
Develops, drive and execute Continuous Improvement & Automation and Digitalization maturity roadmaps in alignment with MedTech Strategies for Sites under scope, from the workshop #1 completion until completion and hyper care process of the Site road map.
Identifies next gen and digital solutions that will advance digital transformation maturity and enable target business value
Identifies efficiencies through automation and digital solution projects including creating business cases
Develops, drive and execute process improvement projects and roadmaps in alignment with MedTech transformation strategies, framework and playbook.
Identifies process optimization opportunities that help deliver target transformation maturity and value
Develop & Operationalize strategies to foster a Continuous Improvement Culture thru training Framework development, provide Courses, and Mentor & Certify resources.
Led Training Strategy to develop Calendar, Training Materials, and Coordinates Sessions related to development of Target organizational Capabilities.
Deploys and utilizes effective project and program risk management tools; proactively identifies, mitigates, and escalates issues as needed.
Guides and coaches core team members and local site teams on execution, adoption of new practices, and capability building to sustain results.
Ensures personal and organizational compliance with Company guidelines and applicable Health, Safety & Environmental practices and all Federal, State, local, and Company regulations, policies, and procedures; performs other duties as assigned.