Principal R&D Consumables Engineer

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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 Med Tech, 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.

R&D Product Development

Biomedical Engineering

Scientific/Technology

Irvine, California, United States of America

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. We solve 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.

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.

• 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 trade‑offs 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; elevate risks appropriately and propose mitigation strategies.

• 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 (Solid Works), 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,…