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

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Job Function:

R&D Product Development

Job Sub Function:

Biomedical Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

We are searching for the best talent to join our DePuy Synthes Orthopaedics team as a Principal Engineer, Process Improvement, based in West Chester, PA; Raynham, MA; Warsaw, IN; or Palm Beach Gardens, FL.

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 Orthopedics? Ready to join a team that’s reimagining how we heal? Our Orthopedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. 

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Summary: This senior individual contributor drives cross-functional process improvements across product development and adjacent medical device business processes (R&D, quality, regulatory, manufacturing, supply chain, and post-market) at platform scale. Leads multiple concurrent, medium-to-high complexity projects from problem definition through implementation and sustainment, focused on increasing speed-to-market, quality, and compliance within a globally distributed organization. Works collaboratively and influences matrixed stakeholders across business units without direct supervisory authority. Demonstrates knowledge of a broad set of complex functional processes and how they interrelate to support innovation objectives.

You will:

• Lead and deliver multiple process improvement projects (Lean Six Sigma, DMAIC, Kaizen) that reduce cycle time, rework, and handoffs across product families and global sites.
• Map, analyze, redesign, and standardize end-to-end workflows for critical processes (requirements management, design control, V&V, change control, stage-gate, or other business processes) with attention to detail needed to enable effective execution.
• Establish pragmatic KPIs and dashboards, measure ROI for initiatives, and present results to functional leaders to secure sustained adoption.
• Integrate risk-based thinking into process design to ensure compliance with 21 CFR 820, ISO 13485, ISO 14971 and other applicable regional regulations.
• Use root-cause analysis (5 Whys, Fishbone, FMEAC), statistical analysis, and experiments to validate solutions; partner with data/BI resources to operationalize metrics.
• Develop and deliver training, SOPs, and change management tactics for global rollouts; support local process adoption across sites and suppliers.
• Coach cross-functional project teams and subject matter experts in structured problem solving without direct line management.

Qualifications: 

Required

• Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree preferred.
• 8+ years experience in a regulated industry environment. Experience in a global/growing enterprise preferred.
• 5+ years experience in medical device product development, quality systems, manufacturing, or process improvement;
• Demonstrated experience leading multiple projects in a matrixed organization and influencing stakeholders at the director level.
• Deep knowledge of medical device regulations (21 CFR 820, ISO 13485, ISO 14971).
• Familiarity with Lean/Six Sigma methods; Green Belt or better preferred.
• Strong data analysis and visualization skills (Excel, Power BI/Tableau); familiarity with PLM/QMS systems.
• Excellent communication skills for cross-regional collaboration and geographically displaced teamwork.

Preferred

• Familiarity with software development and/or lifecycle processes

• Experience in cost-of-quality improvement initiatives in a multi-product company.
• 10% Domestic and/or international travel required. 
• Excels at Cross-functional and global virtual collaboration

#LI-AM2

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

Required Skills:

 

 

Preferred Skills:

Clinical Trials Operations, Coaching, Communication, Critical Thinking, Healthcare Trends, Medical Affairs, Organizing, Product Development, Project Reporting, Research and Development, Researching, Resource Planning

 

 

The anticipated base pay range for this position is :

$117,000.00 - $201,250.00

Additional Description for Pay Transparency: