Job Details

Sr. Manufacturing Process Engineer

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Sr. Manufacturing Process Engineer. This is an exciting opportunity to make your mark on a growing organization. Successful candidates will possess a minimum of a B.S. in Engineering preferably in Mechanical, Electrical, Chemical, or Computer Engineering and 5 Yrs. experience in Design and Development or Manufacturing Engineering required. 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.
• May supervise Technician, Engineering, Prototype or Programming personnel.

Education and Experience: B.S. in Engineering required; preferably in Mechanical, Electrical, Chemical, or Computer Engineering. Masters Degree in Engineering or Business preferred. 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.

Knowledge and Skill Requirements/Specialized Courses and/or Training: Expert knowledge of Materials and relevant Machine design/function. 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. 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. Proficiency in drafting process specific Master Validation Plans. Proficiency in drafting and executing complex engineering study protocols, DOE's, analyzing data, managing deviations and writing reports. Ability to use project management tools (MS Project, Mindview, WorkFront) 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. Ability to create complex, new RPi and PLC programs

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.