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 Senior Manufacturing Process 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 projects involving: rapid commercialization of new products; commercialization of new laser, passivation, cleaning, assembly, and mechanized equipment; improvements to equipment; data collection; process performance improvements; increases in productivity and production capacity; and ongoing reduction of costs. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™ , located at our Ave Maria, FL manufacturing site.
First Shift - 8am- 5:00pm- Monday- Friday
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.
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, new RPi and PLC programs (specific to automation roles only).
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.
Education/Experience:
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.
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.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
