At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

Johnson & Johnson is hiring for aStaff NPI Engineer - Shockwave Medicalto join our team located inSanta Clara CA.

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments. Ready to join a team thats 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 companys manufacturing operations and product launch timelines. This role is responsible for designing developing testing documenting and implementing processes tooling and fixtures throughout the product lifecyclefrom design through production.

Essential Job Functions

• 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 companys quality policy system and objectives.

• Maintain documentation for design control product configurations manufacturing procedures lot history records (e.g. bills-of-materials MPIs LHRs) 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 companys intellectual property portfolio through invention disclosures and patent applications.

• Supports company goals policies procedures quality sSystems and FDA regulations.

• Perform other duties as assigned. This job description is not intended to be an exhaustive list of all responsibilities duties and skills required.

Requirements

• Bachelors degree in Mechanical or Biomedical Engineering with 8 year of engineering experience or a Masters 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 DOEs 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.

Additional Information

• The anticipated base pay range for this position is $125000 to $201250 annually.

• 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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys 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 Companys 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

• Additional information can be found through the link below. 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.

  NOTE:This job description is not intended to be all-inclusive. Employee may perform other related duties as assigned or negotiated to meet the ongoing needs of the organization.

  Johnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

  Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

  Required Skills:

  Preferred Skills:

  Bioinformatics Biological Engineering Biostatistics Coaching Critical Thinking Design of Experiments (DOE) Healthcare Trends Industry Analysis Innovation Medicines and Device Development and Regulation Product Development Relationship Building Research and Development Researching SAP Product Lifecycle Management Standard Scientific Processes and Procedures Technologically Savvy

  The anticipated base pay range for this position is :

  $125000.00 - $201250.00

  Additional Description for Pay Transparency: