Principal R&D Validation Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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 were 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 thats 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 patients lifetime.

Your unique talents will help patients on their journey to wellness. Learn more at 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 handson technical leadership crossfunctional 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.

You will be responsible for:

• Own the technical qualification roadmap and architecture for major consumable products or portfolios; define technical strategy key milestones and success metrics.
• Lead complex multidiscipline 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 highlevel design reviews.

• Lead root-cause and corrective actions
• Drive adoption of advanced engineering methods (e.g. simulation multiphysics modeling DOE advanced prototyping tolerance analyses) to accelerate development and derisk 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 seniorlevel program and governance meetings providing clear datadriven 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 Qualifications

• Bachelors degree in Mechanical Engineering Biomedical Engineering or related engineering discipline; Masters 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 crossfunctional 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 experience in material selection
• Six Sigma Black Belt
• Patents or publications in relevant technical areas.

Competencies & Leadership Expectations

• Strategic thinking and systemslevel perspective.
• Strong decision making under uncertainty; prioritizes highimpact 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 handson 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 crossfunctional alignment at design transfer and successful firsttime 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 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 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

The anticipated base pay range for this position is :

$117000.00 - $201250.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

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 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 period10 days

Volunteer Leave 32 hours per calendar year

Military Spouse Time-Off 80 hours per calendar year

For additional general information on Company benefits please go to: - Experience:

Staff IC