Manufacturing Process Engineer

4 weeks ago


Gainesville, United States CSG Talent Full time

Job Title: Manufacturing Process Engineer

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.

Responsibilities:

  • 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.
Desired Skills and Experience

xactech's manufacturing operations.


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