The Role

• • A Principal NPI Production Engineer leads projects to establish or improve the manufacturing processes of a range of technically complex products (both medical and non-medical devices).
  • They strongly focus on Project management and client and internal stakeholder communication, as well as understanding the technical and regulatory background of both product and process to ensure informed decisions are made in an efficient manner.
  • Responsible for providing guidance to junior engineers on a broad range of manufacturing fundamentals.
  • This is an onsite position. 

• • • Manages and leads the establishment and maintenance of complex regulated
    • Manufactured products. Continuously improve the manufacturing process with a focus on quality, lean assembly and manufacturing processes for the business success
    • Develop and own of plans, schedules, improvements for review and approval by Management
    • Audits manufacturability of existing and new transfer products, and recommends modifications or adaptations to address quality, customer, product, or productivity constraints.
    • Creates and modifies manufacturing cell layouts to ensure most efficient and productive layout and equipment are available to support technicians.
    • Monitors and ensures mandatory modifications are incorporated as required by the customer and the applicable regulatory requirements, to ensure legal compliance and adherence to quality standards. 
    • Successful presentation of dashboards, reports of key metrics and communication with client and key stakeholder relationships at a peer technical level 
    • Supports other engineers in the resolution of product manufacturing issues
    • Support, mentor and guide production engineers in the DFM, establishment and implementation of new product introduction and design transfer
    • Provides hands on execution and coaching of the lean principles (Value Stream Mapping, Kaizen, 5S, Standard Work, Line/Cell Design, Material Flow, Visual Management, Root Cause Problem Solving, etc.) and tools to eliminate waste in all operations functions
    • Owns and leads PFMEAs and supports Control Plans and other lean manufacturing efforts.
    • Collaborate with Quality, Test Engineering, Manufacturing, Service and Product Compliance to define and document early in product development life cycle and continues to drive DFx improvements through Design reviews and product launch in MFG facilities.
    • Manage multiple projects in providing status, conflict resolution, reporting through dashboards in managing client’s expectations.
    • Technically responsible for product drawing reviews, process flow charts, design reviews and feasibility risk assessments including relevant engineering documentation such as risk assessments, process flow, part criticality, BOM management, supplier establishment, environmental specifications, assembly & test tool assessments etc., 
    • Manage and own IQ, OQ and PQ, line validations on transfer products
    • Assessment and qualification of suppliers, including low cost regions
    • Responsible for product and process change management in conformance with the PI QMS
    • Management of materials non-conformances and supplier improvements within the CAPA system 
    • Ensure compliance with ISO 13485 / ISO 9001 manufacturing process

  
  The Typical Experiences
  • • Bachelor’s degree in engineering or a related area of study and 8+ years of previous experience or the equivalent required
    • Demonstrated experience in transferring products from design to manufacturing through a systematic transfer criteria
    • Experience in new product DFx, establishment and introduction into manufacturing
    • Strong leadership skills, experience in organizing multiple teams
    • Excellent interpersonal, communication, and time management skills
    • Highly organized with acute attention to detail
    • Proven ability to work creatively and analytically in a problem-solving environment
    • Ability to meet deadlines and stay within budget
    • High level of proficiency in Excel, Word, Power point, and Outlook programs
    • Strong team orientation and cross functional attitude
    • Experience working to policies; procedures and international quality standards, including ISO13485, ISO9001, or in a highly regulated medical device industry
    • Ability to travel up to 10% is required