Staff NPI Engineer — Cardio Medical Devices

Biopharma Asia; Santa Clara (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Johnson & Johnson in Santa Clara, CA is seeking a Staff NPI Engineer to advance innovative cardiovascular devices, focusing on peripheral and coronary applications.

You will act as a subject matter expert for process development, oversee pilot manufacturing and testing, and guide products from development into full production, collaborating with R&D, Operations, Regulatory and Quality to ensure robust design and compliant documentation.

Responsibilities

• Collaborate with R&D, QA, and Production departments to design, develop, test, document, and implement processes, tooling, and fixtures.
• Develop, validate, and maintain test methods.
• Develop new catheter manufacturing processes based on design intent and DFM principles.
• Develop and maintain technical documentation such as drawings for equipment, fixtures, components, and assemblies used in manufacturing processes.
• Performs testing, analyzes results and provides recommendations for design selection.
• Analyze, evaluate, source, and coordinate procurement of new materials to support prototyping pilot operations, and design verification and validation activities.
• Develop protocols/reports and perform product in-vitro, in-vivo as well as verification and validation testing.
• Participates in technical design reviews to ensure all design inputs and user needs are met.
• Collect data and analyze process performance and capabilities for both new and existing products.
• Perform tolerance analysis for components, manufacturing materials, packaging, and supplies used for in-house processing.
• Lead efforts to develop and maintain Process Failure Modes and Effects Analyses (pFMEAs).
• Prepare user requirements, technical specifications, and design documentation.
• Identify process requirements, support operations management, and implement necessary equipment and fixtures needed for process development and manufacturing efforts.
• Support product development teams in executing projects from concept to commercialization.
• Contribute to base business and continuous improvement initiatives.
• Support pilot manufacturing and serve as a subject matter expert on design-related inquiries, including regulatory submissions.
• Ensure proper documentation and compliance with the company’s quality policy, system, and objectives.
• 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.

Job description

Johnson & Johnson in Santa Clara, CA is seeking a Staff NPI Engineer to advance innovative cardiovascular devices, focusing on peripheral and coronary applications.

You will act as a subject matter expert for process development, oversee pilot manufacturing and testing, and guide products from development into full production, collaborating with R&D, Operations, Regulatory and Quality to ensure robust design and compliant documentation.