Staff NPI Process Engineer

Johnson & Johnson MedTech is seeking a highly qualified and motivated individual to join our team as Sr. NPI Engineer based in Irvine, CA supporting Cardiovascular business units with focus on Structural Heart and Left Atrial Appendage LAA devices. We're committed to delivering innovative products, solutions, and programs to address unmet customer and patient needs worldwide.

The Sr. NPI Engineer will work closely with the cross functional team to bring new products from development through commercialization and life cycle management.

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/.

Key Responsibilities:

• Design For Manufacture/Assembly: Partner closely with Design Engineering teams to develop and optimize manufacturing processes for new designs. Drive design for manufacturing, automation, and commercialization (DFx) activities on new concepts and products.
• New Process Development: Support rapid process revision and development, addressing process design risks in both function and manufacturability through test to deliver scalable design packages to production. Conceive and develop tradeoff studies that explore, test, and validate new manufacturing processes.
• New Design Realization: Lead the implementation of new designs into manufacturing processes, translating design intent into scalable production solutions. Define and own all Failure Mode Effects and Analysis (FMEA), Measurement Systems Analysis (MSA/Gauge R&R), and Process Capabilities Study (CPK) activities required to deliver and validate production of new designs.
• Test integration: Refine new product qualification and acceptance test processes, pulling in external resources such as test, manufacturing, tooling, vendors, integration, and other design groups as required to deliver stable and scalable testing methods.
• Technology Transfer: establish plans and manage transfer of technology from pilot plant to production site
• Validation and Qualification: Establish and manage validation master plan (IQ, OQ, PQ) and execute in partnership with cross functional teams through commercialization
• Cross-Functional Collaboration: Collaborate closely with R&D, Procurement, and production teams, owning the handoff from development to production.

Qualifications

Required:

• Bachelor's degree in mechanical engineering, biomedical engineering, material science, or other related engineering discipline
• 5+ years of demonstrated experience in developing and integrating manufacturing processes
• 3+ years of experience with development, manufacturing, qualification of medical devices
• 3+ years of experience with new product introduction and validation within regulated industry
• Experience applying new product introduction (NPI) approach to complex product development
• Strong CAD experience (Solid Works), DFMEA/PFMEA experience, and GD&T knowledge
• Strong organizational, analytical, statistical (Minitab), root cause and problem-solving skills
• Experience supporting production development or bringing up new production sites
• Strong communication - comfortable communicating ideas and concerns clearly and persuasively, in both verbal and written forms
• Demonstrated ability to engage technology developers in the industry to apply emerging technologies to innovative solutions

Preferred:

• Experience in product introduction in regulated environments with FDA
• Experience with Nitinol medical devices
• Experience and certification in Project Management methodologies (PMP, Agile, SCRUM)
• Experience and certifications in continuous improvement methodologies (Lean, Six Sigma)

Other:

• Can work in Irvine, CA and Santa Rosa, CA
• Traveling 50% from Irvine to Santa Rosa, CA
• Willing to work onsite Monday- Friday

The anticipated base pay range for this position is 90000 to 144900. California Bay Area - The anticipated base pay range for this position is 105000 to 166635.

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."

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 based on disability.