Manufacturing Engineer II - Sutures Pilot - SC

Arthrex•Pendleton, SC

4d•Onsite

About The Position

Arthrex, Inc. is hiring a Manufacturing Engineer II for its Sutures Pilot operation at the Pendleton, South Carolina manufacturing campus. The role designs, develops, implements, and improves manufacturing processes for medical textiles to produce cost-effective, high-quality medical device products and systems. It also provides manufacturing engineering expertise to create, document, and implement required procedures and documents. The engineer works with project teams and cross-functional partners—including engineering, design engineering, quality engineering, and production—to identify issues and risks and support cost-effective product development and manufacturing introduction. The position supports daily braid and textile manufacturing, assembly, clean-room sterile packaging, and other production efforts; leads or supports process improvements; introduces equipment, products, and processes; and develops work instructions, validation protocols, and efficiency plans. It also contributes to equipment and workspace layout, workforce and workflow planning, preventive maintenance programs, vendor and purchasing decisions, production estimates, and manufacturing requirements analysis.

Requirements

Bachelor’s degree in Engineering, Science, Textile Management, or Mathematics, or equivalent Arthrex experience.
At least 2 years of experience in Manufacturing Engineering or a related field; alternatively, at least 1 year of Manufacturing Engineering experience with a relevant master’s degree, or a PhD in a relevant field.
Proven experience 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.
Strong communication skills and ability to communicate effectively with technical and non-technical staff.
Experienced user of MS Office Suite and CAD.
Experience planning and conducting tests to validate equipment and processes.
Experience completing technical documentation for engineering and manufacturing.
Knowledge of Statistical Process Control (SPC).
Understanding of bills of materials (BOMs) and routings.

Nice To Haves

Medical device manufacturing experience, particularly in textile production or manual assembly environments; suture assembly or other medical device assembly is preferred.
Recognized process-improvement training, such as Lean or Six Sigma.
Industrial Engineering experience.
Familiarity with clean-room practices.
Project management knowledge.

Responsibilities

Work with project teams to identify issues and risks and collaborate with engineering, design, quality, and production teams on product development and manufacturing introduction.
Develop a continuous-improvement culture, skills, and tools to enhance quality and operational excellence.
Lead or support process-improvement initiatives and serve as project leader for key improvement projects, identifying best practices.
Introduce new equipment, products, and processes, and present recommendations and implementation plans to the Leadership Team.
Understand existing manufacturing processes and identify opportunities to improve operational efficiency.
Develop manufacturing work instructions and maintain accurate information and documentation.
Provide process and equipment expertise and support for daily braid and textile manufacturing, assembly, clean-room sterile packaging, and production activities.
Develop action plans for short- and long-range efficiency goals, select production methods, design production fixtures, and establish methods to monitor efficiencies.
Lead or assist with implementing textile product specifications in manufacturing.
Monitor timelines and deliverables to ensure manufacturing process development follows approved project plans.
Develop protocols and coordinate equipment and process validation.
Stay current with methods and technologies used in the medical device industry.
Participate in defining preventive maintenance programs for production equipment.
Investigate and test reliability and quality improvements.
Analyze workforce utilization, space requirements, and workflow, and design equipment and workspace layouts for efficiency.
Confer with vendors about product specifications; arrange purchases of equipment, materials, or parts; and evaluate products against specifications and quality standards.
Estimate production times, staffing needs, and related costs to inform management decisions.
Apply statistical methods to estimate future manufacturing requirements and potential.
Identify issues and risks to support cost-effective new product development and introduction into manufacturing.