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Process Improvement Engineer

2 months ago


Gainesville, Florida, United States Exactech Full time
Job Overview

The Manufacturing Engineer is responsible for developing and sustaining cost-effective, high-quality machining and manufacturing processes, along with the necessary tooling and documentation for all produced components.

Key Responsibilities
  • Support the production floor to achieve business objectives while fostering input from personnel in a self-directed work environment. Collaborate cross-functionally with departments such as Quality Assurance and Design Engineering to address manufacturing challenges.
  • Demonstrate ownership and accountability for all facets of production operations, including safety, scheduling, quality, and team development within assigned areas.
  • Drive the development and enhancement of manufacturing methods for both existing and new products.
  • Identify safe manufacturing processes that yield high-quality products in the most efficient manner.
  • Engage in the formulation of mid and long-term strategies outlining projects that align with business goals, focusing on cost, product quality, and cycle time.
  • Plan and execute process-engineering initiatives for new product development and ongoing product support.
  • Research and implement new technologies to support site growth objectives.
  • Assist supervisors, team leads, and production staff in troubleshooting manufacturing process issues through a thorough root cause analysis and permanent corrective actions.
  • Co-lead initiatives to uphold and enhance shop floor quality controls and best practices alongside area team leaders.
  • Pursue continuous improvement efforts aimed at quality enhancement and cost reduction in designated areas.
  • Act as a change agent, guiding operations towards benchmarked, best-in-class performance.
  • Implement manufacturing processes and conduct equipment installation qualifications and process verification/validation studies.
  • Develop and maintain controlled documentation for manufacturing processes.
  • Utilize control processes within Exactech's Change Management System and Document Change Notifications to enact process modifications.
  • Create schedules to ensure timely project completion and contribute to the development of product project timelines.
  • Understand and apply Quality System regulations and relevant Federal and International standards.
  • Provide project management leadership for the development of new products and current vendor-supplied products or processes integrated into Exactech's manufacturing operations.
Skills, Knowledge, and ExpertiseEducation:
  • Bachelor's degree from an accredited institution or equivalent relevant work experience is required.
Experience:
  • 1-3 years of experience in manufacturing and/or operations, preferably in the medical device sector.
  • Familiarity with Good Manufacturing Practices (GMP) and Lean Manufacturing principles. Experience with FDA Part 820 Quality Systems Regulations is advantageous, particularly in the medical device field.
  • Experience in the development and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation.
  • Knowledge of Siemens NX and Siemens Teamcenter is beneficial.
  • Understanding of geometric tolerancing and dimensioning (GD&T).
  • Ability to create programs and design tooling for component manufacturing from prints or models.
  • Experience with medical device materials such as titanium, cobalt chrome, stainless steel, and UHMWPE.
Functional/Technical Knowledge, Skills, and Abilities Required:
  • Exhibit behaviors that align with Exactech's culture and core values, including integrity, accountability, innovation, and passion.
  • Experience with tool and fixture design or improvement.
  • Experience in manufacturing within a regulated environment.
  • Ability to make data-driven decisions and utilize Six Sigma and Lean methodologies.
  • Strong background in interpreting engineering drawings/specifications and manufacturing processes.
  • Knowledge of ISO and quality procedures.
  • Excellent verbal and written communication skills.