Principal R&D Consumables Engineer

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

Job Function:
R&D Product Development

Job Sub Function:
Biomedical Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Irvine, California, United States of America

Job Description:

About Vision

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 on the possibilities of vision treatments? Ready to join a team that's reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs - from the pediatric to aging eye - in a patient's lifetime.

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 Principal R&D Consumables Engineer based in Irvine, CA.

Purpose: The Principal R&D Consumables Engineer leads the technical strategy and execution for advanced consumable products, driving high-impact product and process development from concept through transfer to manufacturing. This role combines deep hands-on technical leadership, cross-functional program leadership, and strategic vision to solve complex customer and patient needs. The Principal Engineer is responsible for setting engineering direction, ensuring robust design and verification practices, managing technical risks, and mentoring more junior engineers. Works with minimal oversight and routinely influences senior leaders and external partners.

You will be responsible for:

• Own the technical roadmap and architecture for major consumable products or portfolios; define technical strategy, key milestones, and success metrics.
• Lead complex, multi-discipline development programs from concept through design verification, validation, and transfer to manufacturing; manage technical tradeoffs and priorities.
• Provide advanced mechanical and system design leadership: define product architectures, systems interactions, requirements decomposition, and high-level design reviews.
• Lead root-cause and corrective actions
• Drive adoption of advanced engineering methods (e.g., simulation, multi-physics modeling, DOE, advanced prototyping) to accelerate development and de-risk designs.
• Lead and approve design control artifacts, risk management activities (e.g., dFMEA, pFMEA) verification/validation plans, and release decisions in accordance with regulatory and quality requirements.
• Collaborate closely with R&D, Quality, Regulatory Affairs, Manufacturing, Supply Chain, and Commercial to align on manufacturability, scalability, cost of goods, and launch readiness.
• Mentor and develop engineering staff: provide technical coaching, run design reviews, and cultivate engineering best practices across the team.
• Represent R&D engineering in senior-level program and governance meetings, providing clear, data-driven recommendations and status to stakeholders.
• Manage external technical partnerships and suppliers: set technical requirements, qualify vendors, and oversee supplier development when needed.
• Lead generation and protection of IP: identify patentable innovations, contribute to disclosures, and collaborate with legal.
• Provide input on project budgets, resource planning, and timing; escalate risks appropriately and propose mitigation strategies.

Qualifications:

Required Skills & Experience:

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or related engineering discipline; Master's or PhD strongly preferred
• Prior experience with injection molded consumables, tooling/fixtures, assembly processes, or contract manufacturing.
• 10+ years of relevant engineering experience in medical devices, consumables, or closely related industries.
• Experience with advanced CAE tools (SolidWorks), rapid prototyping workflows, and measurement systems.
• Demonstrated experience leading complex product development programs and delivering products to market.
• Demonstrated success managing supplier technical development and qualification.
• Deep knowledge of design controls, verification/validation processes, and applicable regulatory requirements.
• Strong analytical skills and experience using simulation, statistical analysis, and structured problem solving.
• Track record mentoring engineers and leading cross-functional teams.
• Experience leading root-cause and corrective actions utilizing the appropriate tools
• Excellent written and verbal communication; able to present technical content to senior management and external partners.

Preferred Skills & Experience

• Graduate degree in Mechanical Engineering, Biomedical Engineering, or related subject area.
• Patents or publications in relevant technical areas.

Competencies & Leadership Expectations

• Strategic thinking and systems-level perspective.
• Strong decision making under uncertainty; prioritizes high-impact technical work.
• Influencing and stakeholder management at senior levels.
• Coaching and talent development focus.
• Commitment to quality, patient safety, and regulatory compliance.

Working Conditions & Travel

• Office/lab environment with hands-on prototype work as required.
• May require travel to manufacturing or supplier sites (occasional).

Expectations

• Delivery of product programs on schedule, within budget, and meeting performance, quality, and regulatory requirements.
• Clear, maintainable architecture and design justification for assigned product(s).
• Demonstrated reduction in technical risk through application of modeling, testing, and structured verification.
• High performance and growth of direct and indirect engineering reports.
• Strong cross-functional alignment at design transfer and successful first-time manufacturing yields.

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, external applicants please contact us via https://www.jnj.com/contact-us/careers internal employees contact AskGS to be directed to your accommodation resource.

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Required Skills:

Preferred Skills:
CAD Tools, CAE Tools, Critical Thinking, Design Thinking, Fact-Based Decision Making, Feasibility Studies, Mechanical Engineering, Organizing, Process Oriented, Product Development, Project Management Methodology (PMM), Project Support, Research and Development, SAP Product Lifecycle Management, SolidWorks API, Solidworks CAD Design, Technical Credibility, Technical Writing, Vendor Management

The anticipated base pay range for this position is :
$115,000-$197,800

Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits