Sr. Manufacturing Engineer

Department: Manufacturing Engineering

Employment Type: Full Time

Location: Gainesville, FL

Reporting To: Sr Manager Manufacturing Engineering

Description

Create and maintain manufacturing and machining processes, tooling and supporting documentation for all parts produced. Provide support and leadership for new products as well as in-sourcing products as identified by the manufacturing leadership. Assist in the development of manufacturing engineers and associate manufacturing engineers via mentoring and leadership. 

Key Responsibilities

• Support shop floor to deliver business results while encouraging input from area personnel working within a self-directed workforce environment. Interact cross-functionally with other departments such as Quality Assurance and Design Engineering to solve manufacturing problems • Develop tooling and processes for the machining of production items.
• Implement total machining process and run Verification/Validation studies. 
• Develop Multiaxis CNC programs from Siemens NX solid models for prototypes and new products as required by approved engineering projects.
• Provide manufacturing method development and improvement for current and new products.
• Determine safe manufacturing processes that produce a quality product in the most efficient method of manufacturing.
• Participate in the development of mid and long term plans outlining projects to support the business in meeting its objectives with a strong focus on cost, part quality and cycle time.
• Troubleshoot machining processes and make CNC program adjustments when necessary.
• Create and maintain controlled documentation for manufacturing processes.
• Assist in the development of manufacturing machinists. Train machinists on new product processes and methods.
• Mentor and /or Supervise the performance and development of junior level team members
• Identify and execute manufacturing process improvements.
• To provide shop floor support and interact with other departments such as Quality Assurance and Design Engineering to solve manufacturing problems.
• Create and document machining work instructions, operations set up sheets and perform process verifications.
• Develop schedules to ensure timely completion of projects and provide input in the development of product project schedules.
• Use control processes within Exactech’s Change Management System and Document Change Notifications to implement process changes.
• Know and apply the Quality System regulations and any appropriate Federal and International standards.
• Assist and support other project, tasks, responsibilities, employees, teams, and sales personnel as necessary.
• Provides project management leadership for the development of new products, & current vendor supplied product or processes into Exactech manufacturing operation. 

Skills Knowledge and Expertise

Education:

• Bachelor’s Degree from an accredited institution or equivalent relevant work experience required. 

 Experience:

•  Seven years experience creating machining processes from engineering CAD models and prints preferably in the medical device industry.
• Strong experience in CNC machining and programming required.
• Minimum of 7 years of CAD/CAM experience. Siemens NX experience preferred.
• Must have successfully completed a minimum of two major project and three minor projects (e.g., line extensions) of sufficient complexity.
  • During the execution of these projects, must have been involved in all aspects of the manufacturing development process. 
  • A minor project involves the modification, adaptation or extension of an existing product or product line.
• Minimum of 5 years with Good Manufacturing Practices & Lean Manufacturing in the medical device industry preferred.
• Ability to make data driven decisions and utilize Six Sigma and Lean tools.
• Experience in the development and execution of IQ’s/OQ’s/PQ documents.
• Experience in the writing of validation/verification plans.
• Strong experience in CNC machining and programming is required. Knowledge of Siemens NX and Siemens Teamcenter a plus.
• Thorough understanding of geometric dimensioning and tolerancing.
• Experience with medical device materials i.e. titanium, cobalt chrome, stainless steel, and UHMWPE.
• Strong background in the interpretation of engineering drawings / specifications and manufacturing processes. 

Functional/Technical Knowledge, Skills and Abilities Required:

• Exhibits behaviors that directly align with Exactech’s culture and