Principal Advanced Manufacturing Engineer - Mechanical - Ave Maria, FL. (Packaging)

Principal Advanced Manufacturing Engineer - Mechanical - Ave Maria, FL. (Packaging)

Arthrex is seeking a Principal Advanced Manufacturing Engineer to provide process engineering support to AMI Packaging Operations (ex. Laser Mark / Weld, Passivation, Cleaning, Component / Device Assembly, Packaging, Boxing) and INC Product Design teams. The role leads the mechanical design and fabrication of custom semi-automated or fully automated manufacturing equipment, tooling and fixturing, and implements mechanical design solutions to improve safety, quality, and efficiency of manufacturing processes. This is a First Shift position (Monday–Friday, 8 : 00am–5 : 00pm).

Requisition ID : 63860

Title : Principal Advanced Manufacturing Engineer - Mechanical - Ave Maria, FL. (Packaging)

Division : Arthrex Manufacturing Inc (US02)

Location : Ave Maria, FL

Note : Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is currently seeking a Principal Advanced Manufacturing Engineer to provide process engineering support to AMI Packaging Operations and INC Product Design teams to achieve business goals. To lead the mechanical design and fabrication of custom semi-automated or fully automated manufacturing equipment, tooling and fixturing. To implement mechanical design solutions to improve safety, quality, and efficiency of manufacturing processes. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.

Essential Duties And Responsibilities

• Support a customer-focused culture by identifying key customer / user requirements and translating those into functional and design specifications during the design of custom equipment and fixturing.
• Support a continuous improvement culture to enhance safety, quality, delivery, and cost by employing Lean / Six Sigma continuous improvement tools in all projects.
• Support a highly innovative culture by identifying novel / first-of-a-kind solutions, and applying lessons learned through successes and failures.
• Support a fast-paced, accountable, teamwork culture by completing project tasks on-time, identifying potential roadblocks, and effectively communicating status and escalating issues.
• Support new product development, design transfer, and continuous improvement (Kaizen) projects as the subject matter expert for equipment mechanical design and fabrication.
• Maintain compliance with Safety requirements related to ergonomics (human-to-machine interface) and guarding.
• Maintain compliance with Medical Device Quality System requirements related to equipment validation.
• Design and develop mechanical design solutions for custom automation or semi-automated equipment or fixturing.
• Design and develop custom poka yoke, Go / No-Go, and inspection gauges / fixtures as well as mechanical design of automated, inline inspection and test systems for electro-mechanical medical devices.
• Identify and evaluate the optimum mechanical design solutions and equipment components based on the latest available technology and industry best practices.
• Develop capital equipment project scope, budget, milestones, and follow a structured Management of Change process.
• Provide requirements to equipment vendors (OEMs) and review design and specification packages during equipment quotation.
• Create and execute validation protocols and reports compliant with Medical Device requirements (IQ, OQ, PQ).
• Create Equipment maintenance manuals, recommend Preventive Maintenance Plans, and spare parts.
• Create operator work instructions and troubleshooting guides.
• Lead Root Cause Investigations or equipment troubleshooting using structured problem-solving tools (Lean A3, Six Sigma DMAIC) and Statistical Analysis.
• Lead process development or process improvement work using process Failure Mode Analysis (pFMEA) and structured Design of Experiments (DOE's).
• Ensure data and documentation are consistently accurate and complete and in compliance with Good Documentation Practices (GDP).
• May supervise Technician, Engineering, Prototype or Programming personnel.

Education / Experience

Skills

Knowledge

Regularly contributes to the development of new concepts, techniques, and standards. Full knowledge of industry practices and regulations. Considered expert in field within the organization.

Reasoning Ability

Develops design solutions to complex problems at system level, which require the regular use of analysis, ingenuity and innovation. Establishes new precedents and policies. Ensures solutions are consistent with organization objectives.

Discretion / Latitude

Work is performed autonomously. Develops project objectives based on high level department goals. Plans, schedules, and arranges own activities, direct reports and team resources to accomplish objectives. Exercises considerable latitude in determining approaches to assignment and deliverables. Proposals are reviewed by leadership for alignment with corporate objectives.

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

Language And Communication Skills

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.

Work Environment

The work environment is a general office or open cubicle / workstation environment with reasonable accommodations as needed. The area is typically moderate in noise level.

Benefits

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

Seniority level

Employment type

Job function

Referrals increase your chances of interviewing at Arthrex by 2x.

J-18808-Ljbffr