Staff Manufacturing Engineer (NPI) - Shockwave

Johnson & Johnson • Santa Clara, CA

36d

About The Position

Johnson & Johnson is hiring for a Staff Manufacturing Engineer (NPI) - Shockwave Medical 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 Staff Manufacturing Engineer is responsible for designing, developing, testing, documenting, and implementing processes, tooling, and fixtures throughout the product lifecycle - from design through production. The role works closely with the R&D Process Engineer (the Subject Matter Expert) to obtain critical information for product process development. The Staff Manufacturing Engineer also collaborates with Production, Quality, and R&D teams to support manufacturing operations and product launch timelines.

Requirements

• Bachelor's degree in Mechanical or Biomedical Engineering with 8+ years' experience, or a Master's degree in Mechanical or Biomedical Engineering with 5+ years' experience.
• Minimum of eight (8) years of experience in a medical device environment or equivalent experience in regulated industries such as pharmaceutical or automotive.
• Strong understanding of engineering materials, component selection, and design for reliability and manufacturability.
• Knowledge of and compliance with applicable Quality System requirements including QSRs, FDA, ISO, MDD and other relevant regulations.
• Experience with process validations (IQ, OQ, PQ), 6S, Lean Manufacturing principles.
• Proficiency in applying statistics and using statistical software, including conducting capability studies (Cpk's), and analyzing design of experiences (DOE).
• Strong written and verbal communication skills, including the ability to create and deliver presentations.
• Experience with software such as: Solidworks, Minitab or similar tools.
• Ability to work in a fast-paced environment. managing multiple priorities effectively.
• Capable of working independently or part of a team, with flexibility to adapt to changing requirements.
• Ability to occasionally lift objects up to 25 lbs.

Nice To Haves

• Accelerating
• Coaching
• Critical Thinking
• Facility Management
• Good Manufacturing Practices (GMP)
• Lean Manufacturing Principles
• Lean Supply Chain Management
• Manufacturing Engineering
• Performance Measurement
• Product Design
• Program Management
• Project Engineering
• Project Scheduling
• Risk Compliance
• Robotic Automation
• Safety-Oriented
• Science, Technology, Engineering, and Math (STEM) Application
• Technologically Savvy

Responsibilities

• Collaborative with R&D, QA and Production departments to design, develop, test, document, and implement manufacturing processes, tooling, and fixtures.
• Design and develop manufacturing processes in compliance with the company's Design Control and applicable regulatory requirements.
• Collect and analyze data on process performance and capabilities for both new and existing products.
• Prototype and develop proof-of-concept designs and bench models to test concepts in simulated environments.
• Develop, validate, and maintain test methods.
• Perform tolerance analysis for components, materials, packaging, and supplies used in-house processing.
• Lead the development and maintenance of process Failure Modes and Effects Analyses (pFMEAs).
• Prepare user requirements, technical specifications, and design specifications.
• Identify process needs, support operations management, and implement required equipment and fixturing development and manufacturing.
• Develop and maintain documentation in support of design control, product configurations, manufacturing procedures, lot history records, (e.g., bills of materials, MPI's, LHR's), and other Quality System requirements.
• Evaluate existing engineering processes and implements process improvements.
• Lead or actively participate in product/process engineering problem-solving using DMAIC methodology.
• Lead or support process and product improvement projects in collaboration with production, R&D engineers and technicians.
• Assist Procurement and R&D departments with supplier selection and technical development.
• Recommend and evaluate new technologies to improve system performance and reliability.
• Conduct productivity and cost analyses, including direct labor, time studies& materials cost estimates, offering solutions to improve efficiency and scalability.
• Create a stability matrix in Phase 4 to assess the sustainability of product transfer. Sustaining Engineering will maintain sustainability, with support from the Staff Manufacturing Engineer.
• Identify cost-reduction opportunities and implement savings strategies for existing products.
• Support the product line transfers and qualification/validation efforts.
• Perform other duties as assigned. These responsibilities are not intended to be an exhaustive list of all duties and skills required.

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
• Industry: Chemical Manufacturing
• Number of Employees: 5,001-10,000 employees