Packaging Process Engineer - Medical Products

Description

Gore is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork. Through our product leadership, we've been changing lives and changing industries, including medical devices, fabrics, electronics, and manufacturing, for more than 50 years. What can you change by joining Gore? Visit gore.com/change-life to find out.

 

Job Description

Gore Medical Products has provided creative therapeutic solutions to complex medical problems for 35 years, saving and improving the quality of lives worldwide. As a leading manufacturer of vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, and sutures, we are looking for an Engineer with an interest in process engineering and Packaging System Development to join the Packaging and Sterilization team in Elkton, MD.

 

If you are searching for a company where you can make a difference, we're looking for you. In this role, you will work closely with Manufacturing, New Product Development, Sterilization Engineering, Quality Assurance, and Purchasing. You will provide support for day-to-day operations and drive project based work focused on process improvement and new packaging systems. In this role, you will incorporate the fitness-for-use requirements of the products and their packaging into your projects.

 

The ideal candidate will:

 

• Be passionate about developing, commercializing, and supporting products that are the highest quality in their class.
• Be energized by working for a world-class manufacturer and collaborating on cross-functional teams.
• Recognize the importance of building and maintaining strong interpersonal relationships.

 

Responsibilities include:

• Supporting packaging processes related to existing device manufacturing and the development and transition of new products into manufacturing
• Managing non-conforming raw materials and products
• Creating procedures and providing training and coaching to other technical and manufacturing associates
• Working with vendors to identify proper packaging materials and components as well as troubleshooting raw material issues 
• Working as an extended team member with New Product Development teams to understand customer needs and leading package development efforts 
• Creating, executing, and analyzing experiments using statistical methods
• Writing and performing validations of product, processes, and equipment in accordance with FDA and ISO guidelines
• Developing specifications for packaging related materials

Qualifications

Required Qualifications:

• A bachelor's degree in Engineering or Science
• Minimum of 3 years of Engineering experience in a manufacturing environment
• Solid knowledge of engineering fundamentals and the proven ability to apply this knowledge to process support and/or package development
• Demonstrated ability to
• • Prioritize, plan, and drive projects to completion
  • Concurrently manage multiple products and projects
  • Work effectively in team situations as well as independently
  • Effectively interface and influence associates in manufacturing, quality assurance, regulatory, product specialists, technical and plant leadership as well as external suppliers
• Ability to work effectively within a regulated environment quality system
• Demonstrated problem solving and trouble shooting skills
• Excellent oral and written communication and interpersonal skills
• Hands-on involvement with all phases of your projects
• Knowledge of the fundamentals of statistics
• Must be able to periodically work in a clean room environment wearing clean room garments
• Willingness to travel domestically (<10%)

Desirable Qualifications:

• A working knowledge of manufacturing/quality assurance systems (such as Good Manufacturing Practices (GMPs) and ISO9000)
• Experience with:
  • Applying lean manufacturing tools and concepts
  • Applying design for manufacture techniques to product development
  • Packaging design, materials, and manufacturing in medical device or other regulated industry
  • Designing and validating packaging systems in accordance with the ISO 11607 part 1 and part 2 standards
  • Using SolidWorks

Gore is committed to a drug-free workplace.  All employment is contingent upon successful completion of drug and background screening.

EEO/AA Employer (applies to all positions located in the U.S.)

 

 Keywords: Gore, job, Baltimore, Philadelphia, Wilmington, DE, MD, PA, Elkton, engineer, engineering, packaging, packages, material, process, implantable, medical, device, manufacturing, industrial, new, product, development, statistical, statistics, data, analysis, design, development, validation, implementation, qualification, troubleshooting, improvement, procedures, experiments, standards, requirements, control, quality, clean, room, supplier, project, environmental, monitoring, regulated, GMP, ISO, 9000, 13485, SolidWorks, CAD, CPP, fitness for use, plan, planning, projects

 

Job Number: 131445
Job Type: Experienced Professional
Job Function: Engineer/Scientist
Primary Location: North America, United States, Maryland, Elkton


Travel: Yes, 10 % of the Time
Shift: Day (1st shift)

Apply