Principal R&D Validation Engineer

We are building the next generation of smarter, less invasive, more personalized treatments in vision to empower eye care professionals and patients to protect, correct, and enhance healthy sight throughout life. We are searching for the best talent for a Principal R&D Validation Engineer based in Irvine, CA. Purpose: The Principal R&D Validation Engineer leads the technical strategy and execution for advanced consumable product qualifications specializing in injection molded components, 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 R&D Engineer sets engineering direction, ensures robust design and verification practices, manages technical risks, and mentors more junior engineers. Works with minimal oversight and routinely influences senior leaders and external partners. Responsibilities Own the technical qualification 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 for moldability/manufacturability, supplier engagement, 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 (simulation, multi‑physics modeling, DOE, advanced prototyping, tolerance analyses) to accelerate development and de‑risk designs. Lead and approve design control artifacts, risk management activities (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; escape risks appropriately and propose mitigation strategies. Required Qualifications Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related engineering discipline; Master’s or PhD strongly preferred. Prior experience with injection molding, tubing extrusion of consumables, tooling/fixtures, assembly processes, or contract manufacturing. 10+ years of relevant engineering experience in medical devices, consumables, or closely related industries. Demonstrated success managing supplier technical development and qualification IQ/OQ/PQ, DOE, GRR. Experience with advanced CAE tools (SolidWorks), rapid prototyping workflows, measurement systems, and project planning programs (MS Project). Demonstrated experience leading complex product development programs and delivering manufacturable products to market. 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 Qualifications Graduate degree in Mechanical Engineering, Biomedical Engineering, or related subject area. Hands‑on process development experience in extrusion and injection molding; material science background with experience in material selection. Six Sigma Black Belt. 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. Required Skills CAD Tools CAE Tools Critical Thinking Design Thinking Fact‑Based Decision Making Mechanical Engineering 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 Preferred Skills CAD Tools CAE Tools Critical Thinking Design Thinking Fact‑Based Decision Making Mechanical Engineering 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 Salary The anticipated base pay range for this position is: USD 117,000.00 – USD 201,250.00. Benefits Vacation – 120 hours per calendar year. Sick time – 40 hours per calendar year (48 hours for Colorado residents; 56 hours for Washington residents). 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. Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year. Caregiver Leave – 80 hours in a 52‑week rolling period. Volunteer Leave – 32 hours per calendar year. Military Spouse Time‑Off – 80 hours per calendar year. 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 #J-18808-Ljbffr