CSG
Manufacturing Engineer Job at CSG in Gainesville
CSG, Gainesville, FL, United States, 32635
Job Title: Manufacturing Process Engineer
Job Highlights:
Job Highlights:
- Bachelor's degree from an accredited university or equivalent relevant work experience.
- 1-3 years of experience in manufacturing and/or operations.
- Familiarity with GMPs (Good Manufacturing Practices) and Lean Manufacturing principles.
- Experience in the development and execution of IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) documents.
- Knowledge of geometric tolerancing and dimensioning (GD&T).
- Ability to design and program tooling for component manufacturing based on prints or models.
- Experience with medical device materials.
- Demonstrates behaviors aligned with Exactech's core values: Integrity, Accountability, Innovation, and Passion.
- Experience in tool and fixture design or improvements.
- Experience working in a regulated manufacturing environment.
- Ability to make data-driven decisions using Six Sigma and Lean tools.
- Strong background in interpreting engineering drawings, specifications, and manufacturing processes.
- Knowledge of ISO and quality procedures.
- Excellent verbal and written communication skills.
- Develop and maintain the most cost-effective, high-quality machining and manufacturing processes, tooling, and supporting documentation for all parts produced.
- Collaborate with cross-functional teams, including Quality Assurance and Design Engineering, to solve manufacturing problems.
- Take ownership of production operations, ensuring safety, meeting production schedules, maintaining quality standards, and fostering team development.
- Provide support for method development and continuous improvement for both new and existing products.
- Identify and implement safe manufacturing processes that ensure the highest product quality while optimizing efficiency.
- Participate in the creation of mid- and long-term plans to support business objectives, with a focus on cost reduction, quality improvement, and cycle time optimization.
- Plan and implement engineering activities for new product development and existing product support.
- Research and apply new technologies to support site growth and operational improvements.
- Work closely with supervisors, team leads, and production employees to resolve manufacturing issues, ensuring root cause analysis and permanent corrective actions are applied.
- Co-lead efforts to maintain and improve shop floor quality controls and best practices.
- Drive continuous improvement efforts for quality and cost reduction in designated areas.
- Act as a change agent, helping the operation reach benchmarked, best-in-class performance.
- Implement manufacturing processes and lead equipment installation qualifications, as well as process verification/validation studies.
- Maintain controlled documentation for manufacturing processes and changes in accordance with Exactech's Change Management System.
- Develop and manage project schedules, ensuring timely completion of tasks and contributing to product project timelines.
- Understand and apply Quality System regulations and federal/international standards in manufacturing processes.
- Provide project management leadership in the development of new products and the integration of vendor-supplied products or processes into Exactech's manufacturing operations.