Manufacturing Engineer
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 ExpertiseEducation:
- 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