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Senior Manufacturing Engineer

2 weeks ago


Gainesville, United States Exactech Full time
Senior Manufacturing Engineer

Department: Manufacturing Engineering

Employment Type: Full Time

Location: Gainesville, FL

Reporting To: Sr Manager Manufacturing Engineering

Description

Create and maintain manufacturing and machining processes, tooling and supporting documentation for all parts produced. Provide support and leadership for new products as well as in-sourcing products as identified by the manufacturing leadership. Assist in the development of manufacturing engineers and associate manufacturing engineers via mentoring and leadership.

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 • Develop tooling and processes for the machining of production items.
  • Implement total machining process and run Verification/Validation studies.
  • Develop Multiaxis CNC programs from Siemens NX solid models for prototypes and new products as required by approved engineering projects.
  • 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.
  • Troubleshoot machining processes and make CNC program adjustments when necessary.
  • Create and maintain controlled documentation for manufacturing processes.
  • Assist in the development of manufacturing machinists. Train machinists on new product processes and methods.
  • Mentor and /or Supervise the performance and development of junior level team members
  • Identify and execute manufacturing process improvements.
  • To provide shop floor support and interact with other departments such as Quality Assurance and Design Engineering to solve manufacturing problems.
  • Create and document machining work instructions, operations set up sheets and perform process verifications.
  • Develop schedules to ensure timely completion of projects and provide input in the development of product project schedules.
  • Use control processes within Exactech's Change Management System and Document Change Notifications to implement process changes.
  • Know and apply the Quality System regulations and any appropriate Federal and International standards.
  • Assist and support other project, tasks, responsibilities, employees, teams, and sales personnel as necessary.
  • 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 institution or equivalent relevant work experience required.
Experience:
  • Seven years experience creating machining processes from engineering CAD models and prints preferably in the medical device industry.
  • Strong experience in CNC machining and programming required.
  • Minimum of 7 years of CAD/CAM experience. Siemens NX experience preferred.
  • Must have successfully completed a minimum of two major project and three minor projects (e.g., line extensions) of sufficient complexity.
    • During the execution of these projects, must have been involved in all aspects of the manufacturing development process.
    • A minor project involves the modification, adaptation or extension of an existing product or product line.
  • Minimum of 5 years with Good Manufacturing Practices & Lean Manufacturing in the medical device industry preferred.
  • Ability to make data driven decisions and utilize Six Sigma and Lean tools.
  • Experience in the development and execution of IQ's/OQ's/PQ documents.
  • Experience in the writing of validation/verification plans.
  • Strong experience in CNC machining and programming is required. Knowledge of Siemens NX and Siemens Teamcenter a plus.
  • Thorough understanding of geometric dimensioning and tolerancing.
  • Experience with medical device materials i.e. titanium, cobalt chrome, stainless steel, and UHMWPE.
  • Strong background in the interpretation of engineering drawings / specifications and manufacturing processes.
Functional/Technical Knowledge, Skills and Abilities Required:
  • Exhibits behaviors that directly align with Exactech's culture and embodies the core values of Exactech.
  • Excellent verbal and written communication skills.
  • Ability to work both independently and within a team.
  • Knowledge of ISO / quality procedures.