Job Details

Manufacturing Engineer

Department: Manufacturing Engineering

Employment Type: Full Time

Location: Gainesville, FL

Reporting To: Senior Manager Manufacturing Engineering

Description

Create and maintain the lowest cost, highest quality machining & manufacturing processes, tooling and supporting documentation for all parts produced.

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
• Exhibit ownership and take responsibility in attaining all aspects of production operation including safety, scheduling, quality, and team development in assigned areas
• 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
• Plan and implement process-engineering activities for new product development and current product support
• Investigate and apply new technology in support of site growth plans
• Assist supervisors, team leads, and production employees in resolving manufacturing process problems through a drive to root cause and permanent corrective action
• Co-lead efforts to maintain and improve shop floor quality controls and best practices with area team leaders
• Pursue continuous improvement for quality and cost reductions in designated area
• Act as change agent, understanding and moving the operation toward benchmarked, best of class performance
• Implement manufacturing processes and execute equipment installation qualifications and process Verification/Validation studies
• Create and maintain controlled documentation for manufacturing processes
• Use control processes within Exactech's Change Management System and Document Change Notifications to implement process changes
• Develop schedules to ensure timely completion of projects and provide input in the development of product project schedules
• Know and apply the Quality System regulations and any appropriate Federal and International standards
• Provides project management leadership for the development of new products, & current vendor supplied product or processes into Exactech manufacturing operation

• Bachelor's degree from an accredited university or college or equivalent relevant work experience required.

• 1-3 years of Manufacturing and/or operations experience. Medical Device Industry a plus.
• Familiar with GMP's, and Lean Manufacturing. FDA Part 820 Quality Systems Regulations experience is a plus preferably in the medical device industry
• Experience in the development and execution of IQ's/OQ's/PQ documents.
• Knowledge of Siemens NX and Siemen Teamcenter is a plus.
• Understanding of geometric tolerancing and dimensioning (GD&T)
• Ability to create programs and design tooling for the manufacture of components from a print or model.
• Experience with medical device materials i.e. titanium, cobalt chrome, stainless steel, UHMWPE

• Exhibits behaviors that directly align with Exactech's culture and embodies the core values of Exactech.
  • Integrity: Exhibits honesty and demonstrates strong moral principles
  • Accountable: Supports teammates and delivers on actions, commitments, and projects
  • Innovative: Introduces new technology and listens to unsolved challenges to better develop solutions that make a real difference to processes and products
  • Passionate: Driven to help teammates, improve processes, and ensure product quality; help surgeons help patients
• Experience with tool and fixture designs or improvement
• Experience in manufacturing in a regulated environment
• Ability to make data driven decisions and utilize Six Sigma and Lean tools
• Strong background in the interpretation of engineering drawings / specifications and manufacturing processes
• Knowledge of ISO / quality procedures
• Excellent verbal and written communication skills