Manufacturing Engineer

4 months ago

Gainesville, United States Exactech Full time
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
Skills Knowledge and Expertise

Education:
  • Bachelor's degree from an accredited university or college or equivalent relevant work experience required.
Experience:
  • 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
Functional/Technical Knowledge, Skills and Abilities Required:
  • 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

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