NPI/LCM Senior Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at ;br>
Job Function:
Supply Chain Engineering

Job Sub Function:
Project Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Irvine, California, United States of America

Job Description:

Biosense Webster, a part of J&J MedTech, is recruiting for an NPI/LCM Senior Engineer located in Irvine, CA.

Atrial fibrillation (AFIB) is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications. 20 million people around the world suffer from AFIB each year.

Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders. The company established its leadership in electrophysiology with the development of the first real-time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter. The introduction of the company's CARTO 3 System in 2009 revolutionized 3D mapping technology by increasing the accuracy, speed, and efficiency of the cardiac ablation procedure.

About the Role:

The successful candidate will be working within a cross-functional project team through all phases of the product development process, planning and executing projects through the product launch and support of product after launch. The candidate will work closely with members of the project core team (R&D, Quality Engineering, Marketing, Finance, Sourcing, Plan, External Manufacturers etc.,) to define user needs, generate design concepts and prototypes, perform design evaluations (such as tolerance analysis, FEA, DOE's, simulated use testing, etc.), and support development of product and process validation plans and testing during the development and full life cycle of the product. The candidate will also be involved in test method development and evaluation of the proposed design.

The NPI/LCM Senior Engineer will work with cross functional team and suppliers to optimize designs for manufacturability and produce prototypes. The candidate should demonstrate an understanding in the application of design controls and development processes. The candidate should have the ability to prioritize tasks and manage a varied workload, exhibit strong written and verbal communication skills and interface effectively with others in the project team.

The NPI/LCM Senior Engineer will be responsible for:

• This NPI/LCM Senior Engineer will be responsible for collaborating with R&D, Quality engineers and External Manufacturers in developing new product designs and supporting the life cycle of existing products within a cross-functional team environment; specifically, to develop and support innovative Product Management solutions for heart rhythm disorders.
• Responsible for establishing the relationship between product design features and the selected methods required to manufacture the product.
• The NPI/LCM Senior Engineer will provide detailed assessments and critical Design for Product Management review of engineering designs/drawings of components and assemblies. He/she will participate in design reviews to assess the design intent, manufacturability, proper dimensioning and tolerancing of components and assemblies to allow product to transition into the Product Management environment.
• The NPI/LCM Senior Engineer will manage the Product Management of prototypes used in new product development, including selecting the most appropriate prototype methods and executing prototype development to support new product design trials.
• Responsible for completing financial estimates of components and assembly Cost of Goods Sold.
• The NPI/LCM Senior Engineer will also provide analysis and recommendations for feature and Product Management cost tradeoffs, during the design phase of new products. He/she will develop comprehensive, cost effective Product Management strategies, including supplier selection, to drive product team decisions on sourcing to achieve cost and time targets.
• The NPI/LCM Senior Engineer will provide technical support to external manufacturers in process development, characterization, validation and stabilization. He/she will lead technical teams to support launched products through the life cycle of the product. Resolving issues around yield, capacity, cost savings, and other supply chain challenges.
• The NPI/LCM Senior Engineer will support ERP and Quality System assessments and deliverables (Functional Impact Assessments, Routers, Drawing Reviews, Product Quality Plan, process related NPI Non-conformances)
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance

Qualifications

• Bachelor's degree in an engineering discipline is required.
• Minimum 6 years of engineering experience with a BS, or 4years with MS in engineering is required.
• Minimum 3 years' experience in a Product Management, product development, or manufacturing environment is required (i.e. for process development, cycle time, yield and cost improvements)
• Experience working in highly regulated industry is required: Working in medical device industry is preferred.
• Knowledge in the application of Design for Product Management (DFM), including industry best practices and experience in applying DFM to new product designs is preferred.
• Experience in Product Management Cost analysis
• Experience in Root Cause Analysis
• Experience working with an integrated cross-functional new product development team is preferred.
• Process Development- Development and Validating of Manufacturing Processes preferred
• Experience with Geometric Dimensioning & Tolerancing (GD&T) is preferred
• A Green/Black Belt Certification is preferred
• Experience managing outside vendors and suppliers is preferred
• The ability to create designs for production and fabrication is preferred
• Experience solving technical manufacturing issues is preferred
• A broad knowledge of medical device Product Management processes and applications (broad understanding of available Product Management technologies, assembly and inspection techniques and automation is preferred).
• Proficient knowledge of Process Excellence / Six Sigma statistical analysis techniques and its application in Product Management processes is preferred.
• Demonstrated ability to manage design and Product Management-related activities within the requirements of 13485 Design Control requirements is required.
• Strong technical communication and negotiation skills and demonstrated ability to work independently with external suppliers is required.
• Ability to travel up to 20% domestic and international is required

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 & 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, external applicants please contact us via , internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:
Manufacturing, Product Management, Supplier Management

Preferred Skills:
Analytical Reasoning, Budgeting, Collaborating, Communication, Consulting, Customer Centricity, Feasibility Studies, Issue Escalation, Lean Supply Chain Management, Organizational Project Management, Product Reliability, Project Engineering, Quality Assurance (QA), Science, Technology, Engineering, and Math (STEM) Application, Scientific Research, Technologically Savvy

The anticipated base pay range for this position is :
79,000-127,650.00

Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below.