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 (Ex. Laser Mark/Weld, Passivation, Cleaning, Component/Device Assembly, Packaging, Boxing) 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™.

First Shift - Monday- Friday, 8:00am-5:00pm 

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 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 inspectionand 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 Medial 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:

• B.S. in Engineering required
• Minimum of 12 Yrs. experience in Design and Development or Manufacturing Engineering required.
• Proven Experience leading process improvement projects.
• Proven Experience leading new equipment, capital projects.
• Experience leading/ supervising direct reports.
• Experience in medical device manufacturing or other health sciences industry preferred.
• SAP, miniTab, Solidworks experience preferred.
• Lean Six Sigma Green Belt / Black Belt certification preferred.
• Lean Six Sigma Green Belt / Black Belt certification preferred. 

Skills:

• Expert knowledge of Materials and relevant Machine design/function. ·
• Expert knowledge of emerging technologies and applies them to current and new processes.
• Proficiency in Industry Standard (ASTM) Test Methods.
• Proficiency in compliance with ISO regulations and FDA 21 CFR Part 820 with ability to assess and mitigate business and regulatory risks.
• Expert level proficiency using CAD/CAM software including revision control and file management.
• Demonstrated ability to Design for Six Sigma and Lean Six Sigma.
• Proficiency in developing and auditing Master Validation Strategies and Plans processes for compliance with industry, regulatory, and internal quality standards.
• Proficiency in drafting and executing complex engineering study protocols, DOE’s, analyzing data, managing and resolving deviations and writing reports.
• Proficiency in using project management tools (MS Project, Mindview, Workfront) to plan and track large capital projects.
• Expert in analyzing existing equipment and processes, identifying issues and implementing solutions. 
• Proficiency in preparing complex capital equipment proposals including cost analysis and justification (ROI).
• Assist in preparing annual CapEx and expense Budgets. · Ability to communicate ideas, results, recommendations, and status effectively in oral and written forms to executive management.
• Ability to directly and effectively supervise technicians, contractors, and engineers.
• Proficiency in innovating new design solutions to modify existing equipment or design new, fully custom equipment. · Proficiency in new or custom equipment design.
• Ability to identify new Information Systems requirements to improve business processes.
• Seek, identify, mitigate, and control through sound methods and techniques sources of process variation and process parameters that significantly influence process outcomes.
• Demonstrated ability of innovating and designing solutions to modify existing equipment or design new, fully custom equipment.

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.

Reasoning Ability:

Ability to define problems, collects data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

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.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear.

The employee is frequently required to stand for 8-10 hours per day wearing gowns, hairnets, and gloves; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must frequently lift and/or move up to 20 pounds. Must possess the dexterity to utilize writing utensils (pen/pencil), calculators, small hand-held tools, manual razors, and other mechanical/electrical equipment without assistance. Ability to work in close proximity to fellow teammates in cramped conditions.

Vision Requirements:

Visual acuity necessary to do the job safely and effectively.

Specific vision abilities required by this job include close vision using a microscope and light source

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The area that this job is performed in is a general office or open cubicle/workstation environment. The noise level in the work environment is usually moderate.

Arthrex Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)

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.