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Job DescriptionJob DescriptionDescriptionCreate 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
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