Requisition ID: 53659 Title: Manufacturing Process Engineer I Division: Arthrex Manufacturing Inc (US02) Location: Ave Maria, FL

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex Manufacturing is looking for a Manufacturing Process Engineer I to join our team at our facility in Ave Maria, FL. This Engineer will provide process engineering support to AMI Packaging Operations and INC Product Design teams to achieve business goals. To lead projects involving: rapid commercialization of new products; commercialization of new laser, passivation, cleaning, assembly, and mechanized equipment; improvements to equipment; data collection; process performance improvements; increases in productivity and production capacity; and ongoing reduction of costs. Candidates with experience in programming equipment and electromechanical - motors, sensors, and equipment controls is a plus. Documentation and writing validation protocols preferred. Statistical analysis is highly desired. This position will be at our manufacturing facility in Ave Maria, FL. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• Support new product development/design transfer by leading process development and validation.


• Develop and support a continuous improvement culture to enhance quality, operational excellence, and cost.


• Develop and maintain Master Validation Strategies and Master Validation Plans for component manufacturing, device assembly, packaging, data collection, and process efficiency.


• Draft and execute validation protocols and reports (IQ/OQ/PQ) for manual assembly and mechanized processes.


• Lead the design, development, and commercialization of new equipment including gathering user requirements, designing equipment mechanical and electrical systems, developing equipment specifications, coordinating quotes and procurement of new equipment with vendors, validation, work instruction development, BOM and Router management, and training of operations.


• Confers with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluates products according to specifications and quality standards.


• Design, develop, and manage tooling and fixtures. Coordinate quotes and procurement of new tooling with vendors. Assess and execute validation requirements accordingly.


• Support the maintenance of equipment and tooling once released to production through troubleshooting, repair tracking, and analysis of impact to the validated state.


• Introduce and support new equipment, products, and processes utilizing industry standard project management tools and techniques.


• Develop an understanding of current manufacturing processes and identify targets for improvement in data collection/trending, work order transaction processes, and operational efficiencies.


• Lead process improvement projects through Designed Experiments (DOE's), structured problem solving (Lean A3, Six Sigma DMAIC), and Statistical Analysis.


• Ensure data and documentation are consistently accurate and complete.


• Applies statistical methods to estimate future manufacturing requirements and potential.


• Analyzes and plans workforce utilization, space requirements, and workflow, and designs layout of equipment and workspace for maximum efficiency utilizing lean techniques when feasible.


• Estimates production times, staffing requirements, and related costs to provide information for management decisions.


• Develop sampling procedures, forms, and instructions for recording, evaluating, and reporting quality and reliability data.


• Remain current with ISO/FDA/ASTM standards and internal quality assurance policies. Support Audits as the process subject matter expert.

Education/Experience:

Bachelor's degree in Engineering required; preferably in Mechanical, Electrical, Chemical, or Computer Engineering.

Packaging Co-Op or internship experience preferred.

Experience in medical device manufacturing or other health sciences industry preferred.

SAP, Minitab, SolidWorks experience preferred.

Skills:

Basic knowledge of Materials and Machine design/function.

Basic understanding of select manufacturing processes.

Basic knowledge of Industry Standard (ASTM) Test Methods

Basic knowledge of using CAD and MS Office Suite software.

Ability to update PLC programs Ability to execute process validations, analyze data, and write reports.

SPC (Statistical Process Control) knowledge preferred.

Ability to draft and execute engineering study protocols, analyze data, and write reports.

Detail oriented with strong analytical and communication skills.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.