Career Opportunities

Senior Packaging Engineer

Posted on: Friday, October 26, 2018
Organization: CONMED Corporation
Location: Utica, NY
Description:

At CONMED, Packaging Engineers work to ensure that our diverse offering of medical device products are packaged in a way that maintains safety, quality and sterilization. The work of our Packaging Engineers directly contributes to the accessibility and reliability of our products for our health care customers around the world. We are seeking a talented and driven Senior Packaging Engineer to join the our Utica, NY based Advanced Engineering team. This engineer will have immediate opportunities to lead ongoing sustaining and new product packaging initiatives by implementing innovative and cost effective technical solutions in order to support the organization throughout the product lifecycle, including full scale production.

As a Senior Packaging Engineer, you will define innovative and high valued products for the business, create and develop novel concepts and designs, lead the verification and validation testing of these designs, and fully transfer new devices to manufacturing. Additionally, you will also be responsible for the support of current products in manufacturing. Throughout this process, you will support the efficient, high quality design and development of medical device systems, working cross-functionally with manufacturing, project management, R&D, procurement, regulatory, marketing, quality and operations team members, as well as external suppliers.

At CONMED, Packaging Engineers work to ensure that our diverse offering of medical device products are packaged in a way that maintains safety, quality and sterilization. The work of our Packaging Engineers directly contributes to the accessibility and reliability of our products for our health care customers around the world. We are seeking a talented and driven Senior Packaging Engineer to join the our Utica, NY based Advanced Engineering team. This engineer will have immediate opportunities to lead ongoing sustaining and new product packaging initiatives by implementing innovative and cost effective technical solutions in order to support the organization throughout the product lifecycle, including full scale production.

As a Senior Packaging Engineer, you will define innovative and high valued products for the business, create and develop novel concepts and designs, lead the verification and validation testing of these designs, and fully transfer new devices to manufacturing. Additionally, you will also be responsible for the support of current products in manufacturing. Throughout this process, you will support the efficient, high quality design and development of medical device systems, working cross-functionally with manufacturing, project management, R&D, procurement, regulatory, marketing, quality and operations team members, as well as external suppliers.

Duties and responsibilities include:

  • Design:
    • Develop packaging specifications and associated engineering documents
    • Develop packaging testing methods, perform or direct test method validations and train others to use these methods as required
    • Perform validation of new or modified packaging designs to appropriate and current regulatory standards
    • Work directly with outside suppliers to develop optimal package designs and/or components
    • Coordinate and communicate packaging technology and designs with project teams and management staff as part of project management and design control activities
    • Identify, review and evaluate new packaging technology for application to current and future product designs
    • Participate in development of risk analysis associated with packaging design and associated processes
    • Document all packaging and labeling design, development, and testing to comply with FDA design control regulations and industry standards for sterile barrier packaging systems and processes
    • Identify and assess new medical packaging material and perform selection and analysis
  • Process:
    • Collaborate with manufacturing engineering and manufacturing staff to design, specify, implement and validate equipment and processes required to support the packaging process
    • Collaborate with and/or support supplier quality engineering and manage packaging process validations with external packaging and packaging component suppliers
    • Collaborate with packaging vendors to evaluate and select optimal packaging technology to meet customer needs
    • Develop/implement production/processing methods and controls to meet quality standards in most cost efficient manner
    • Identify opportunities to improve packaging processes by Designing/Developing/Implementing new packaging technologies
    • Prepare equipment (IQ,OQ, PQ) and process performance validation (PQ) protocols and reports
    • Prepare operating procedures for new equipment and processes
    • Identify, initiate and implement projects to improve productivity and reduce scrap/reject rates through process enhancements and effective training of production personnel, and address any compliance related packaging issues
    • Translate end user requirements to packaging functional specifications
    • Develop URS/FAT, design verification, DOE/SPC process optimization and validation (IQ, OQ, PQ) and MiniTab, TOPS
  • Quality:
    • Investigate and resolve work-in-process problems in order to maintain and improve equipment availability for the production operation
    • Maintain and improve product quality by performing and documenting robust root cause investigations and implementing effective corrective and preventive actions as part of the CAPA process.
Requirements:

This role requires a driven and responsible team player who can think creatively while keeping business objectives front of mind. If you enjoy working in a cross-functional, fast paced, LEAN environment with tangible machines, processes and medical device products, we invite you to apply for consideration!

Candidates will be evaluated based on the following criteria:

  • Bachelor of Science degree required. Major in Packaging Engineering, Packaging Science or a related field strongly preferred
  • Bachelor's degree with 5+ years packaging related professional work experience, or Master's degree with 3+ years packaging related professional work experience required
    • Solid strong business and financial acumen and ability to digest and synthesize data quickly
    • Ability to lead with influence and develop trusting business relationships across functions and site locations
    • Ability to use problem solving skills to improve line efficiencies on a day to day basis
    • Knowledge of standards, Corrective and Preventative Actions (CAPA) and test methods used in the medical device industry
    • Knowledge of statistical analysis tools
    • Highly proficient with Microsoft Office Programs (Word, Outlook, Excel, etc.)

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