Sr. Manufacturing Process Engineer

About the role

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. This is an exciting opportunity to make your mark on a growing organization.

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.
• Confer with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluate 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.
• Analyze and plan workforce utilization, space requirements, and workflow, and design layout of equipment and workspace for maximum efficiency utilizing lean techniques when feasible.
• Estimate 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.
• Support Audits as the process subject matter expert.
• May supervise Technician, Engineering, Prototype or Programming personnel.

Requirements

• 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.

Qualifications

• Expert knowledge of Materials and relevant Machine design/function.
• Proficiency in Industry Standard (ASTM) Test Methods.
• 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.
• Ability to work in a general office or open cubicle/workstation environment.

Skills

• Expert knowledge of Materials and relevant Machine design/function.
• Proficiency in Industry Standard (ASTM) Test Methods.
• 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.

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)

Pay

TBD

Schedule

TBD