Principal R&D Consumables Engineer

Johnson & Johnson•Irvine, CA

4d•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 https://www.jnj.com 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.

Requirements

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.

Nice To Haves

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

Responsibilities

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.

Benefits

medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
Company’s consolidated retirement plan (pension)
savings plan (401(k))
Company’s long-term incentive program
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