NPI/LCM Senior Engineer

Johnson & Johnson•Irvine, CA

29d

About The Position

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.

Requirements

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.
Experience in Product Management Cost analysis
Experience in Root Cause Analysis
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

Nice To Haves

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 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.

Responsibilities

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.
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.
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.
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.
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.
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

Benefits

medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
consolidated retirement plan (pension)
savings plan (401(k))
long-term incentive program
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
Pay Transparency