Senior Manager R&D Consumables - Johnson and Johnson

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/.

Johnson & Johnson MedTech focus on Vision is recruiting for a R&D Senior Manager (Consumables) located in Irvine, CA.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

We are seeking a highly skilled, experienced, and passionate leader to transform the future of ophthalmic surgery. In this role, you will lead a team of engineers and cross-functional partners in the design and development of innovative surgical instrumentation, consumables and accessories critical to cataract extraction and related procedures. Your leadership will be guided by the principles of Our Credo as you coach and develop your team and work hands-on together to solve complex problems and bring innovations to market that address unmet needs for our patients and customers.

Responsibilities:

• Recruit, train, motivate, review, and develop your high-performance staff in the design and development of advanced ophthalmic surgical instruments, consumables, and accessories from conceptualization to final product sales, to achieve short-term and long-term project milestones and business objectives

• Collaborate closely with surgeons and their staff, industry-leading scientists, product managers, global marketing, industrial designers, and engineers from such disciplines as systems integration, electrical, mechanical, reliability, test, and manufacturing to define project requirements, specifications, and objectives

• Coach your team to excellence in the use of design tools such as CAD software, modeling and simulation, GD&T, six sigma, CTQ flow down, tolerance analysis design for X, and other relevant tools & techniques to create high-performing designs, 3D models, engineering drawings, and specifications

• Architect systems, propose process improvements, and collaborate hands-on with engineering colleagues to solve challenging requirements and optimize for interoperability between consumables and capital equipment

• Drive innovation and research efforts to identify and incorporate new technologies, materials, and design concepts that enhance product performance and usability. Seek out new technology partners. Create and drive technology and product roadmaps. Submit invention disclosures and participate in patent drafting and review.

• Identify opportunities for process improvements, propose and implement design enhancements, and optimize product designs for manufacturability, cost-effectiveness, reliability, and quality.

• Create, contribute to, review, and/or approve change orders, technical reports, regulatory submissions, risk assessments, industry presentations, and promotional material - providing subject matter expertise, adhering to standard operating procedures and industry standards, and demonstrating exceptional attention to detail.

• Develop and manage capital, expense, project, and travel budgets.

• Manage the use of laboratory/facility space and equipment in a safe and compliant manner. Ensure group compliance with applicable corporate and divisional policies and procedures as well as global standards and regulatory requirements.• BS in Mechanical, Biomedical, Electrical, or a related engineering or science discipline is required.

• Advanced degree (MS, Ph.D) preferred.

Experience:

• 10 years of experience in R&D and new product/technology development is required.

• 5 years of direct, functional management/supervision, including leading principal/fellow-level engineers and front-line managers/supervisors, is required.

• Experience building/growing an organization, coaching/mentoring, and leading through change is required.

• Experience with project management is required.

• Experience in a regulated industry is required. Ophthalmology industry experience is preferred.

• Experience with FDA and global regulatory design controls, process development and control, risk management, verification and validation, statistical analysis, and new product development under ISO13485 and 14971 standards

• Experience with associated product and testing requirements is required.

• Experience with high-volume injection molding of low-cost plastic parts to tight tolerances, tubing, bonding, welding, adhesives, solvents, sterilization, and reprocessing is required.

• A record of successfully advancing innovation and bringing products to market, including leading design transfer, manufacturing bring-up, and manufacturing support / sustaining engineering is required.

• Experience with surgeons to gather voice-of-customer and by visiting operating rooms is preferred.

• A demonstrated, sound scientific and engineering approach to root-cause analysis, problem solving, and issue resolution, combined with a good understanding of relevant technologies at the theoretical level as well as their practical level, is required.

• Expertise with CAD (Solidworks preferred but other packages are acceptable), modelling and simulation, engineering change control, product lifecycle management (ePDM), driving compliance to engineering drawing standards such as Geometric Dimensioning and Tolerancing per ASME Y14.5, and a strong understanding of metrology is required.

• Mastery of the application of engineering fundamentals to achieve product design requirements is required.

• Strong executive communication skills are required, i.e. explaining complex technical concepts to higher-level stakeholders, transparent written and verbal communication, and creating presentations.

• Experience with business concepts such as profitability, operating expenses, capital expenses, net present value, and portfolio prioritization is required.

• This position may require up to 25% travel both domestically and internationally.

This job posting is anticipated to close on 1/10/2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

An internal candidate has been identified for the role however all applications will be considered.

The anticipated base salary for this position is $137,000 -$235,000 .

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits:
• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market."

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