Staff NPD Engineer

Johnson & Johnson•Irvine, CA

36d•$94,000 - $151,800

About The Position

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Biosense Webster, a Johnson and Johnson company, is recruiting for a Staff Engineer, Product Management, located in Irvine, CA. 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. The Staff Product Management Engineer will be supporting project teams in the development of electrophysiology catheters and systems at Biosense Webster and provides advice and mentorship to less experienced personnel. 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. 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. The candidate will also be involved in test method development and evaluation of the proposed design. The Staff Product Management 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.

Requirements

Bachelor's degree in an engineering discipline, preferably Mechanical or Electrical engineering is required.
Minimum 6 plus years of engineering experience with a BS, or 4 years with MS in engineering is required.
Minimum 6 years' experience in a Product Management 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 required.
Experience in Product Management Cost analysis
The ability to develop and utilize 3D CAD models, FMEA's, GD&T, tolerance analysis, FEA, DOE's, simulated use testing, and statistical analysis is preferred.
Experience working with an integrated cross-functional new product development team is required.
Project Management experience is required
Process Development- Development and Validating of Manufacturing Processes preferred
Experience with Geometric Dimensioning & Tolerancing (GD&T) is required
Experience with component process development 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
This position reports to the NPD Engineering manager, Principal Engineer, or Engineering Director
Staff Engineer may have NPD Engineers as subordinates

Responsibilities

This Staff Product Management Engineer will be responsible for collaborating with R&D, Quality engineers and External Manufacturers in developing new product designs within a cross-functional team environment; specifically, to develop innovative Product Management solutions for heart rhythm disorders.
He/she will be responsible for establishing the relationship between product design features and the selected methods required to manufacture the product.
The Staff Product Management 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 Staff Product Management 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.
He/she will be responsible for completing financial estimates of components and assembly Cost of Goods Sold.
The Staff Product Management 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 Staff Product Management Engineer will provide technical support to external manufacturers in process development, characterization, validation and stabilization.
The Staff Product Management Engineer will support ERP and Quality System assessments and deliverables (Functional Impact Assessments, Routers, Drawing Reviews, Product Quality Plan, process related NPI Non-conformances)
The Staff Product Management Engineer can mentor entry level engineers and technicians and will oversee suppliers to optimize designs for manufacturability and assembly to produce functioning prototypes and supporting production documentation.
Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.
Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.