Integra LifeSciences

  • Sr. Engineer, Sustaining

    Vacancy ID
    2018-28140
    Location
    US-MA-Mansfield
    Position Type
    Regular Full-Time
    Category
    Engineering
  • Overview

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    Responsibilities

    • Participate on cross-functional project teams including R&D, Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and Manufacturing to maintain and improve surgical products
    • As a recognized manufacturing process technical expert who can provide engineering knowledge and oversight to resolve manufacturing- and quality-related problems with existing products.
    • Support and lead manufacturing process improvements for CSS products in both internal manufacturing facilities and in partnership with external suppliers.
    • Provide project leadership to improve existing products and associated manufacturing processes.
    • Design, specify, develop and procure manufacturing tooling, fixtures and equipment, and will lead the implementation and validation of such manufacturing processes and equipment.
    • Support the selection and validation of replacement materials, such as polymers, metals, and adhesives, for CSS applications.
    • Write and revise assembly procedures and work instructions for manufacturing, and provide the oversight to implement such procedures.
    • Identify and provide innovative new manufacturing technologies from industry best practices that can be applied to CSS products.
    • Represent the Manufacturing Engineering group on strategic projects in manufacturing and sourcing.

    Qualifications

    • Minimum of a Bachelor’s degree in Mechanical, Manufacturing, Materials or Biomedical Engineering with a minimum of 6 years of relevant experience or a Master’s degree in Engineering with 5 years of relevant engineering experience is required.
    • Medical device industry experience is preferred.
    • Knowledge of how to execute GMPs, ISO 13485 Design Control, and manufacturing process IQ, OQ, PQ qualifications as related to medical devices is required.
    • Knowledge of Six Sigma Process Excellence is preferred, Black Belt certification is preferred.
    • Knowledge in manufacturing processes such as polymer processing (molding, compounding, extrusion, fusing), metal processing (machining, laser cutting, polishing, welding), assembly, equipment & tool design is required.
    • Knowledge of Design for Manufacturability in plastics, metals and small scale assembly processes is preferred.
    • Knowledge of financial accounting and analysis methods to assess product standard costs, project values, cost improvements and capital purchases is preferred.
    • Leadership experience in managing technical relationships with external suppliers and OEMs is required.
    • Strong communication, team building, and cross-functional coordination skills are required.
    • This position is to be located in Mansfield, MA and may require up to 10% travel, including international.

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