Sr Manufacturing Engineer I

Arthrex

7d•Onsite

About The Position

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Senior Manufacturing Engineer I for our Pendleton, SC manufacturing location. Successful candidates must possess a Bachelor’s degree in an Engineering or Engineering Technology discipline with at least 5 years of relevant experience. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™. Main Objective: Responsible for supporting Engineering Manager with all support for the life cycle development of Class I, II and III medical devices, including new product development and maintenance of released products. This includes design, develop, implement and improve manufacturing processes to produce cost effective quality medical device products and systems. Provide manufacturing engineering expertise to create, document and implement required procedures and documents.

Requirements

Bachelor’s degree in Engineering or Engineering Technology required.
5 years of manufacturing process improvement experience required.
Experienced in leading process improvement projects.
Ability to work independently and effectively with cross functional teams.
Thorough understanding of manufacturing processes.
Detail oriented with strong analytical skills.
SPC (Statistical Process Control) knowledge.
Strong communication skills and ability to communicate effectively with technical and non-technical staff.
Experienced user of MS Office Suite and CAD.
Experience with planning and conducting tests to validate equipment and processes.
Experience in completing technical documentation for engineering and manufacturing.

Nice To Haves

Medical device manufacturing environment preferred.
Experience in workflow optimization, work measurement, efficiencies.
Recognized process improvement training (Lean, Six Sigma) preferred.
Familiarity with clean room practices preferred.
Project management skills preferred.
Solidworks experience preferred.
CAM experience preferred.

Responsibilities

Work with project teams to identify issues and risks. During new product development integrate with Engineers, Design Engineers, Quality Engineers and the Packaging Department/and or Production Department to ensure cost effective new product development and introduction into manufacturing.
Develop a continuous improvement culture, skills sets and tools to enhance quality and operational excellence.
Support process improvement initiative.
Introduce new equipment, products, and processes. Utilizing industry standard project management tools and techniques.
Present process and equipment recommendations to Leadership Team with regular and timely reviews that will define team roles, responsibilities, and accountability to project plans for implementation.
Initiate new projects and be the Project Leader for key improvement initiatives, identifying best practices.
Develop an understanding of the current manufacturing processes and identify targets for improvement in transactional and operational efficiencies.
Develop manufacturing Work Instructions.
Provide process support on manufacturing technical issues.
Develop action plans to achieve short and long-range efficiency goals, selection of new production methods, designs of production fixtures, and methods to monitor efficiencies.
Lead and/or assist with implementation of packaging design/and or production specifications into manufacturing.
Monitor timelines and project deliverables to ensure adherence with approved project plans for manufacturing process development.
Develop protocols and coordinate validation of equipment and processes.
Stay current with methods used in the medical device industry to advance technologies.
Investigates and test in time reliability and quality improvements
Drives automation to replace the manual process as much as possible
Ensure Information and documentation is consistently accurate
Analyzes and plans workforce utilization, space requirements, and workflow, and designs layout of equipment and workspace for maximum efficiency.
Confers with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluates products according to specifications and quality standards.
Estimates production times, staffing requirements, and related costs to provide information for management decisions.
Applies statistical methods to estimate future manufacturing requirements and potential.
Provide process and equipment support.
Identify issues and risks to ensure cost effective new product development and introduction into manufacturing.
May supervise other Engineering, Prototype or Programming personnel.