Sr. Manufacturing Engineer (NPI) - Shockwave

Johnson & Johnson • Santa Clara, CA

2d • $105,400 - $142,600

About The Position

Johnson & Johnson is hiring for a Sr. Manufacturing Engineer (NPI) to join our team located in Santa Clara, CA. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Senior Manufacturing Engineer is responsible for designing, developing, testing, documenting, and implementing processes, tooling, and fixtures throughout the product lifecycle, from design to production. The Senior Manufacturing Engineer will work closely with production, quality, and R&D teams to support the company’s manufacturing operations and product launch timelines.

Requirements

• Bachelor’s degree in Engineering.
• Minimum five (5) years of experience in a medical device environment or 3 years of experience with a master's degree.
• Knowledge of and compliance with applicable Quality System requirements (e.g., traceability QSRs, ISO and MDD requirements)
• Experience implementing Lean and Lean Sigma concepts.
• Experience with Validation of Medical Devices (IQ-OQ-PQ).
• Ability to use special software such as: Solidworks, Minitab or related.
• Ability to work in a fast-paced environment while managing multiple priorities
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• May be required to occasionally lift objects up to 25lbs.

Nice To Haves

• Proficiency in Statistics (Cpk, Hypothesis Testing, DOE, Gage R&R) a plus.

Responsibilities

• Work collaboratively with R&D, QA and Production departments to design, develop, test, document and implement processes, tooling, and fixtures.
• Support and work with Quality to address and resolve non-conformances.
• Collect data and analyze process performance and capabilities for company products, including new products and products already in production.
• Identify process requirements, advise and support operations management, and implement equipment and fixtures needed for process development and manufacturing efforts.
• Develop and maintain documentation for design control, product configurations, manufacturing procedures, lot history records, (e.g., bills-of-materials, MPI’s, LHR’s), and other Quality System requirements.
• Lead and/or actively participate in product/process engineering problem solving using DMAIC methodology.
• Lead and/or actively participate in process/product continuous improvement projects (in cooperation with development engineers and technicians).
• Apply Lean manufacturing principles in production processes to reduce/eliminate waste and increase productivity
• Assist Procurement and R&D departments with supplier selection and technical development.
• Perform productivity and costing analyses (e.g., calculate direct labor & materials costs for new products, identify and implement cost reduction plans for existing products).
• Other duties as assigned.

Benefits

• 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
• Work, Personal and Family Time - up to 40 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees