• Product Engineer, truFreeze

    June 7, 2017 • Careers

    Product Engineer, truFreeze – Engineering – Systems Department

    Location: CSA Medical Headquarters, Lexington, MA

     

    Job Description

    The Product Engineer coordinates all engineering and production activities for new and existing products with the Contract Manufacturer (CM). The individual also identifies and oversees execution of sustaining engineering projects to improve device performance and reliability. 

    Duties and Responsibilities

    This may include but is not limited to the following:

    • Acts as manufacturing/operations representative on product development teams.
    • Maintains ownership of contract manufacturing process for capital equipment and disposables.
    • Assists Contract Manufacturer in the investigation and troubleshooting of manufacturing or design issues. Assists with test method development and validation (MSA/Gage R&R).
    • Leads weekly meetings with Contract Manufacturer to track progress and identify key issues related to CSAM products.
    • Leads monthly production forecast and inventory reviews. Reconciles CSA and CM production records and gathers updates from all stakeholders.
    • Responsible for design and verification activities relating to component obsolescence, high failure items, and evaluation of design changes requested by suppliers.
    • Monitors and addresses product complaints. Provides technical expertise to CAPA teams, leading when appropriate. Coordinates engineering activities in the event of product malfunctions or recall.
    • Drives sustaining engineering efforts including the following: Identifies and implements required changes to product specifications. Outlines and performs verification and validation activities, utilizing design of experiments to determine sampling plans. Identifies and leads design and/or procurement and qualification efforts when test fixtures are required.
    • Manages external consultants or vendors to supplement internal engineering capacity when required.
    • Evaluates and approves deviation and non-conforming material reports from Contract Manufacturer with the appropriate CSA Medical personnel.
    • Reviews and approves Contract Manufacturer invoices.
    • Documentation and report writing (Medical Device Regulatory Standards).

    Skills & Competencies

    Position requirements, qualifications and experiences:

      • B.S. Degree in engineering required, M.S. preferred
      • Minimum of 4 years’ engineering experience in medical device, manufacturing, or related field.
      • Some travel required.
      • Excellent teamwork and communication skills
      • Strong SolidWorks experience required, PDM vault experience preferred.
      • Experience maintaining and updating product BOMs and drawings.
      • Experience with Minitab or equivalent statistical analysis tools.
      • Strong commitment to customer service and order fulfillment.
      • Strong experience with investigations and troubleshooting of technical issues.
      • Flexibility and adaptability to change, including the ability to multi-task in a fast paced environment
      • Self-motivated and organized.
      • Experience with FDA / QSR and ISO 13485 or equivalent quality systems.

    How to Apply:

    Submit your resume and cover letter to careers@csamedical.com

    CSA Medical, Inc. is an equal opportunity employer.

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