1. Provides project management leadership for the development of new products processes into Exactech manufacturing operation.
2. Create and maintain additive manufacturing files for all parts produced.
3. Develop tooling and processes for the creation of production items.
4. Implement additive manufacturing process and run Verification/Validation studies.
5. Develop additive manufacturing programs from Unigraphics solid models for prototypes and new products as required by approved engineering projects.
6. Troubleshoot additive manufacturing processes and make program adjustments when necessary.
7. Define maintenance plan to maintain additive manufacturing equipment, materials, consumables and supporting equipment to meet quality and safety standards (including powders, powder recycling equipment, hand tooling, build plates, filters, etc). Perform routine maintenance as needed. Mentor/supervisor technical services staff as needed.
8. Create additive manufacturing work instructions.
9. Assist in the development of additive manufacturing machinists. Train machinists on new product, processes and methods resulting from additive manufacturing.
10. Mentor and /or supervise the performance and development of operators and/or additive manufacturing application engineers.
11. Identify and execute additive manufacturing process improvements.
12. To provide additive manufacturing operator support and interact with other departments such as Quality Assurance and Design Engineering to solve additive manufacturing problems.
13. Use control processes such as Document Change Notifications to implement process changes.
14. Create and document additive machining work instructions, operations set up sheets and perform process verifications.
15. Develop schedules to ensure timely completion of projects and provide input in the development of product project schedules.
16. Provides project management leadership for the development of new products, & current vendor supplied product or processes into Exactech additive manufacturing operation.
17. Know and apply the Quality System regulations and any appropriate Federal and International standards.
18. Assist and support other project, tasks, responsibilities, employees, teams, and sales personnel as necessary.
Bachelor’s Degree from an accredited institution or equivalent relevant work experiencerequired.
• Seven years experience in manufacturing and machining process development. Medical Device Industry a plus.
• Seven years experience creating machining processes from engineering CAD models and prints preferably in the medical device industry. MAGICS CAD software highly preferred.
• Experience with Laser or Electron Beam additive 3D printing systems is highly preferred.
• Familiar with GMP’s, and Lean Manufacturing. FDA Part 820 Quality Systems Regulations experience is required preferably in the medical device industry.
• Experience in the development and execution of IQ’s/OQ’s/PQ documents.
• Strong experience in additive manufacturing is required.
• Thorough understanding of geometric tolerancing.
• Ability to create programs, Magics experiencepreferred, and design tooling for the manufacture of components from a print or model.
• Experience writing IQ/OQ/PQ documents.
• Experience writing Validation/Verification plans.
• Experience with medical device materials i.e. titanium, cobalt chrome, stainless steel, UHMWPE.
• Excellent verbal and written communication skills.
• Effective team player.
Functional/Technical Knowledge, Skills and Abilities Required:
• Ability to work independently.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
Bachelors or better.