• Engineering Team Lead

    Posting Date 1 week ago(8/7/2018 3:48 PM)
    Requisition ID
    2018-4953
    Job Location(s)
    Bloomington IN United States
    Shift Type
    First
    Position Type
    Full Time
    Company
    Cook Medical Holdings
    Category
    Engineering
  • Overview

    The Process Development Team Leader is responsible for leading the engineering team designing and optimizing of processes required to manufacture new medical devices. Provide technical direction and leadership for project teams focused on design, development, and implementation of new processes (internally and externally) required for the manufacture of new device designs.

    Responsibilities


    • Ensure that a risk based approach is applied during the development implementation and validation of all processes.
    • Ensuring that the principles of Design for Manufacture, and Lean manufacturing are central to the R&D process and designs.
    • Teach/mentor team members about the methods needed for efficient and effective process development (design for manufacturing, process validation, process capability, lean manufacturing, equipment selection and specification development).
    • Collaborate with other R&D teams, Operations, and Production engineering to ensure the effective completion of all activities associated with an R&D Engineering project / objective.
    • Monitor and report project progress, delays, and completions.
    • Identify and communicate to management on areas for improvement from a systems and personnel (training and developmental needs) standpoint.
    • Compare costs and benefits when choosing product in-house or supplier selection. 
    • Provide direct and frequent positive and constructive feedback on performance and improvement areas for team members.
    • Review and approve team member documentation (PFMEA’s, Production Instructions, Drawings etc.) and expense reports.
    • Design and optimize process and process equipment for large and small scale manufacturing.
    • Ability to work in collaborative and independent work situations and environments with minimal supervision.
    • Ability to complete projects within specific time lines and meeting performance expectations.
    • Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
    • Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
    • Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
    • Must strictly adhere to safety requirements.
    • Maintain regular and punctual attendance.
    • Must maintain company quality and quantity standards.
    • Must have effective communication skills, which may include oral or written
    • Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal
    supervision.
    • Ability to remain calm and receptive in fast paced situations.

    Qualifications

    • Bachelor's degree in Engineering, or related field is required.

    • Minimum 5 years experience in in a medical manufacturing environment. 

    • Strong knowledge of process validation, design for manufacturing, statistics and lean manufacturing principles

    • Strong knowledge of medical device quality standards ISO13485/FDA practices,GMP and similar regulated industry standards.

    • Project and team management experience, is preferred.

    • Proficient in Microsoft Word/Excel/Outlook

    Physical Requirements:

    • Frequently required to sit, stand, walk, and communicate.

    • Occasionally lifting with minimal exertion during shift.

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