Principal R&D Validation Engineer

Johnson & Johnson Innovative Medicine • Irvine, CA

2d • $117,000 - $201,250 • Hybrid

About The Position

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 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 Mechanical Engineering, Biomedical Engineering, or related engineering discipline; Master’s or PhD strongly preferred
• Prior experience with injection molding, tubing extrusion of consumables and consumable components, 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.

Nice To Haves

• Graduate degree in Mechanical Engineering, Biomedical Engineering, or related subject area.
• Hands on process development experience in extrusion and injection molding
• Material science background, experience in material selection
• Six Sigma Black Belt
• Patents or publications in relevant technical areas.

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 (e.g., 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 (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

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 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
• 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
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Principal