Senior Engineer - Sutures Manufacturing

Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. We are actively seeking a Senior Manufacturing Engineer to join our engineering team. Excellent communications and analytical skills, strong manufacturing background along with an Engineering Bachelor’s degree will be essential for this position. The position will be located at our site in Ave Maria, FL. 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 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.

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. 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 expertise and support.
• Identify issues and risks to ensure cost effective new product development and introduction into manufacturing.
• May supervise other engineering personnel.

Education and Experience:

• Bachelor’s degree in Engineering or Engineering Technology.
• 7+ years of manufacturing process improvement experience required.
• Proven experience in leading process improvement projects.
• Medical device manufacturing environment preferred.
• Experience in workflow optimization, work measurement, efficiencies.
• Recognized process improvement training (Lean, Six Sigma) preferred.

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

• 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.
• Familiarity with clean room practices preferred.
• Project management skills preferred.
• Solidworks experience preferred

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock. The noise level in the work environment is usually moderate.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.