Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. To provide Manufacturing Engineering support to ACT Production Operations, Quality Engineering, Supply Chain and Product Design teams to achieve business goals.  Provide Sustaining Manufacturing Engineering support and to lead projects: involving commercialization of new products; defining assembly and mechanized equipment; improvements to equipment; process performance improvements and data collection; increases in productivity and production capacity; ongoing yield improvements and reduction of costs. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• Define and release manufacturing Work Instructions to guide the assembly operations.
• Provide production process support on manufacturing technical issues daily.
• Partner with Quality Engineering in support of Quality Management System (QMS) requirements involving medical device manufacturing and ISO-13485.
• Develop procedures, forms, and instructions for recording, evaluating, and reporting quality and reliability data and perform Root Cause / Corrective Actions.
• Support new product development /design transfer by leading process development and validations by participating in DFx, including Design for Manufacturing, Assembly & Test.
• Drive automation to replace manual processes where economically feasible.
• Support new product development & project management for mechanical and electrical designs thru all phases of the design process.
• Develop and support a continuous improvement culture by utilizing lean principles to enhance quality, operational efficiency and cost.
• Develop and maintain Master Validation Strategies and Master Validation Plans for component manufacturing, device assembly and data collection.
• Lead the design, development and test 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, Bills of Materials (BOM) and training of operators.
• Work with suppliers to determine product specifications and arrange for purchase of equipment, materials, or parts and evaluates products according to specifications and quality standards.
• Draft and execute validation protocols and reports including Installation, Operational and Process Qualifications (IQ, OQ, PQ) for equipment and mechanized processes.
• Design, develops, and manages tooling and fixtures. Coordinates quotes and procurement of new tooling with suppliers.
• Perform Gage R&R and Process Capability Statistical Analysis.
• 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 improvements in operational efficiencies, data collection / trending, SAP work order transaction.
• Lead process improvement projects through Design of 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.
• 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.
• Remain current with ISO/FDA/ASTM standards and internal quality assurance policies.
• Support Audits as a “Subject Matter Expert”.
• May supervise Technicians, Engineers or be an individual contributor.

Knowledge:

• Complete understanding and application of principles, concepts, practices, and standards. Full knowledge of industry practices.
• Reasoning Ability:
• Develops solutions to a variety of complex problems. May refer to established precedents and policies.
• Discretion/Latitude:
• Work is performed under minimal direction. Participates in determining objectives of assignment. Plans, schedules, and arranges own activities and coordinates activities of direct reports and team resources to accomplish objectives. Work is reviewed upon completion for adequacy in meeting objectives.

Skills:

• Advanced knowledge of Materials and relevant Machine design/function.
• Advanced understanding of all relevant manufacturing processes and interdependencies.
• Proficiency in Industry Standard (ASTM) Test Methods.
• Capable of ensuring compliance with ISO 13485 and FDA 21 CFR Part 820 as related to cGMP and Process Validations.
• Advanced CAD software skills required.
• Ability to create complex, PLC programs (specific to automation roles only).
• Proficiency in drafting process specific Master Validation Plans.
• Proficiency in drafting and executing complex engineering study protocols, Design of Experiments (DOE’s), analyzing data, managing deviations and writing reports.
• Ability to use project management tools to plan projects.
• Ability to prepare a capital equipment budget and justification (ROI).
• Ability to communicate ideas, results, recommendations, and status effectively in oral and written forms.
• Ability to coach & mentor junior level engineers and technicians.
• Ability to create and maintain accurate pFEMAs for assigned processes.
• Ability to apply structured problem-solving techniques and develop process design solutions to improve existing manufacturing and/or testing methods.

Education:

• B.S. in Engineering required, preferably in Mechanical, Electrical, Chemical, or Computer Engineering.
• Minimum of 5 Yrs. experience in Design and Development or Manufacturing Engineering required.
• Proven Experience leading process improvement projects.
• 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.

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 Lunch
• Gym Reimbursement Program
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Paid Sick Leave
• 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.