Associate Manufacturing Engineer - Sutures

Arthrex, Inc. Immokalee, FL
Job Description

Requisition ID:



Associate Manufacturing Engineer - Sutures


Arthrex Manufacturing Inc


AMI East- AMI- Ave Maria, FL

This position is for the Sutures Department at the Arthrex manufacturing facility in Ave Maria, FL. Prior sutures experience is strongly preferred.

Main Objective:

Design, develop, implement and improve manufacturing process to produce cost effective quality medical device products and systems. Provide manufacturing engineering expertise to create, document and implement required procedures and documents.

Essential Duties and 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.

* Lead/support process improvement initiative.

* Introduce new equipment, products, and processes. Present process and equipment recommendations to Leadership Team with equipment reviews and 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 operation efficiencies.

* Develop manufacturing Work Instructions.

* Provide process support on manufacturing technical issues.

* Provide process and equipment expertise and support for daily clean-room sterile packaging efforts/and or production efforts.

* 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.

* Participate in defining Preventive Maintenance programs for clean room equipment/ and or production equipment associated with packaging or production activities.

* 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 expertise and support.

* Identify issues and risks to ensure cost effective new product development and introduction into manufacturing.

Incidental Duties:

The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Education and Experience:

Bachelor's Degree in Engineering, Science or Mathematics is required.

Knowledge of suture assembly processes and techniques preferred.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

Ability to work independently and effectively with cross functional teams.

Basic 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.

SPC (Statistical Process Control) knowledge preferred

Machine, Tools, and/or Equipment Skills:

Working knowledge of machining and manufacturing.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills:

Ability to comprehend and