• Product Engineer

    Posted Date 1 week ago(1 week ago)
    Job ID
    2018-2032
    Job Location
    US-TX-Austin
    # of Openings
    1
    Category
    Engineering
  • Introduction

    Is This The Role For You?

     

    We hire smart people with big hearts.  People who have a passion for their work and who strive every day to help others. Our work requires bold and innovative leaders; people who bring strong values and ethics to their role.

     

    If you’re ready for a career that allows you to grow and develop into the professional you want to be – today and in the future….CryoLife is the place for you.

    Position Overview

    Provide comprehensive engineering support for a range of products through all phases of product development and manufacturing; bring new products on-line insuring desired functionality, efficient manufacture, and regulatory compliance; refines existing product processing in order to increase efficiency while maintaining required quality requirements; and troubleshoot and resolve production problems for assigned products.

    Responsibilities

    Key Responsibilities:

    • Interface with Production, Product Development, and other appropriate functions to fully understand and suggest improvements to functionality, performance, and safety requirements of assigned products
    • Support new product introduction schedule and activities, and coordinate and manage cross-product issues throughout the product life cycle
    • Identify, evaluate, and coordinate the development and implementation of new product manufacturing processes
    • Work jointly with Production, Quality Control, Process Engineering, and Quality Assurance to assure that required manufacturing and inspection steps for successful & efficient production of assigned products are properly defined, integrated, implemented & verified/validated
    • Design, provide, or review needed engineering drawings, specifications, procedures, methods, tooling, fixturing, or gaging for processing and inspecting assigned products
    • Determine disposition of discrepant materials or components
    • Ensure acceptable raw materials and components required for supporting in-house production levels are received. This includes identifying new vendors and communicating engineering, quality, delivery, and regulatory requirements.
    • Analyze Manufacturing related problems of assigned products and propose and coordinate implementation of solutions
    • Develop, review and update risk assessment for assigned products
    • Suggest and implement production changes to reduce cycle times and enhance yields
    • Coordinate activities with manufacturing subcontractors to define and design processes and optimize results
    • Communicate technical product status to management, to include yield and quality issues
    • Develop and maintain in-depth knowledge of pertinent Manufacturing Technologies and disseminate this information as requested to various engineering and production groups.

    Additional Responsibilities:

    • Keep knowledge up to date regarding pertinent Manufacturing Systems and Processes; drawing standards; in house procedures, policies and specifications; GMP; ISO 9000 series and other appropriate regulatory requirements
    • Provide various product cost and implementation schedules
    • Design and optimize substrate designs for carbon coated components
    • Travel to vendors, trade shows and between CryoLife facilities, possibly overseas
    • Perform additional duties that may be assigned by Supervisor.
    • Relate to other people beyond giving and receiving instructions: (a) can get along with co-workers or peers without exhibiting behavioral extremes; (b) perform work activities requiring negotiating, instructing, persuading or speaking with others; and (c) respond appropriately to criticism from a supervisor
    • Manage time effectively; prioritize and make good business judgments and decisions in relationship to efficiency

    Qualifications

    • Minimum of a Bachelors degree, preferable of a technical or manufacturing nature
    • Minimum 4 years experience encompassing Engineering and/or Product Design, experience with Medical Devices or other closely regulated products preferred
    • Needs to be knowledgeable in A.N.S.I. drawing standards, CAD, mfg. processes, process control, engineering economics and project scheduling
    • Strong understanding of risk assessment and FMEA
    • Demonstrated ability to take various designs into production
    • Experience in label and IFU design, including coordinating translations, preferred
    • Green Belt in 5S/Lean Manufacturing preferred
    • Self-starter with strong leadership, communication skills and demonstrated problem solving ability
    • Ability to read, analyze, interpret and follow written instructions
    • Ability to interpret and follow oral instructions
    • Required to read, write and speak English with good command of the language, and use moderately complex math
    • Strong computer skills including at minimum, be adept in use of MS Office, internet, and electronic mail
    • Strong interpersonal and communication skills
    • Ability to define problems, collect data, establish facts, and draw valid conclusions
    • Must have a valid driver’s license and a good driving record. Employees in this classification must maintain insurability during the term of employment

    Company Info

    Who We Are.

     

    CryoLife is one of the world’s contemporary medical device companies providing preserved human cardiac and vascular tissues, surgical adhesives and sealants, cardiac lasers and implantable end-stage renal disease access grafts for the repair of complex cardiac and vascular reconstruction surgeries. Since the Company’s inception in 1984, it is estimated that its products and tissues have been implanted in about 900,000 patients worldwide.

     

    CryoLife technology and products bring restoration and hope to people all around the world. CryoLife headquarters are located in Kennesaw, Georgia, a suburb of Atlanta.

     

    CryoLife is an Equal Opportunity/Affirmative Action employer.

    CryoLife is committed to the philosophy of equal opportunity employment. We do not discriminate against any employee or applicant.  All qualified candidates will receive consideration for employment without regard to race, ethnicity, age, religion, sex, sexual orientation, national origin, citizenship, disability, veterans or other legally protected status.

     

    Reasonable Accommodations
    CryoLife is committed to providing reasonable accommodations both in the application and interview process, consistent with legal requirements. If you need a reasonable accommodation while seeking employment, please email ADA_Accommodation@CryoLife.com or call 770-429-5215. A Human Resources representative will return your call. Messages or emails for any reason other than accommodation requests will not be returned.

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