Exactech
Exactech is hiring: Senior Manufacturing Engineer in Gainesville
Exactech, Gainesville, FL, United States
Job Description
Job Description
Description
Key Responsibilities
Skills Knowledge and Expertise
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.