Staff NPI Engineer - Shockwave Medical

Johnson & Johnson-posted 3 days ago

Full-time • Mid Level

Onsite • Santa Clara, CA

5,001-10,000 employees

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Johnson & Johnson is hiring for a Staff NPI Engineer - 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 NPI Engineer will utilize technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The Staff NPI Engineer will serve as a subject matter expert for the process development team, provide oversight to pilot manufacturing/testing, and guide products as they transition from development into full production. This position will participate in multiple cross-functional development teams, focusing on design for manufacturability, process optimization, and sustaining activities. The Staff NPI Engineer will develop, validate, and implement various processes by working closely with R&D, Operations, Regulatory, and Quality teams to support the company’s manufacturing operations and product launch timelines. This role is responsible for designing, developing, testing, documenting, and implementing processes, tooling, and fixtures throughout the product lifecycle—from design through production.

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.
Evaluate and improve existing engineering processes.
Lead or participate in problem-solving initiatives using the DMAIC methodology.
Lead or support process/product improvement projects in collaboration with R&D engineers and technicians.
Assist Procurement and R&D in supplier selection and technical development
Recommend and implement new technologies to enhance system performance and reliability.
Conduct productivity and costing analyses (e.g., time studies, direct labor/materials costs assessments), proposing scalable solutions.
Identify and implement cost reduction strategies for existing products.
Support product line transfers and associated qualification/validation efforts.
Manage supplier relationships to ensure delivery of high-quality components and services.
Enhance the company’s intellectual property portfolio through invention disclosures and patent applications.
Supports company goals, policies, procedures, quality \sSystems, and FDA regulations.
Perform other duties as assigned.

Bachelor’s degree in Mechanical or Biomedical Engineering with 8+ year of engineering experience, or a Master’s degree with 5+ years of engineering experience.
Engineering experience in the medical device industry is strongly preferred.
Knowledge of and compliance with applicable Quality System regulations (QSRs, FDA, ISO, MDD, MDR, etc).
Understanding of Lean and Six Sigma principles.
Experience with medical device validation (IQ-OQ-PQ).
Basic understanding of statistical methods (e.g., Cpk, Hypothesis Testing, DOE’s, Gage R&R) is a plus.
Proficiency in SolidWorks for drawing creation and maintenance.
Experience with ERP and MES (Oracle preferred)
Knowledge of disposable peripheral and coronary device design, material selection, and testing preferred.
Experience in early-stage catheter-based cardiovascular devices project is a strong plus.
Effective communication skills across all levels of the organization.
Proficiency in Microsoft Office software (Excel, Word, PowerPoint).
Ability to work in a fast-paced environment and manage multiple priorities.
Ability to work independently and collaboratively, with adaptability to changing requirements.
Must be able to sit for prolonged periods (more than 2 consecutive hours in an 8-hour day).
Must be able to lift objects weighing up to 25lbs or more.

Engineering experience in the medical device industry is strongly preferred.
Basic understanding of statistical methods (e.g., Cpk, Hypothesis Testing, DOE’s, Gage R&R) is a plus.
Knowledge of disposable peripheral and coronary device design, material selection, and testing preferred.
Experience in early-stage catheter-based cardiovascular devices project is a strong plus.
Experience with ERP and MES (Oracle preferred)

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

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