jobs description

Senior Manufacturing Process Engineer - Ave Maria, FL.

Title: Senior Manufacturing Process Engineer - Ave Maria, FL.

Division: Arthrex Manufacturing Inc (US02)

Location: Ave Maria, FL.

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 and INC Product Design teams to achieve business goals.

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, and coordinating quotes and procurement of new equipment with vendors.
• Confers with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts.
• Design, develop, and manage tooling and fixtures.
• Support the maintenance of equipment and tooling once released to production.
• 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.
• Lead process improvement projects through Designed Experiments (DOE’s), structured problem solving, 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.
• Estimates production times, staffing requirements, and related costs.
• 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.
• May supervise Technician, Engineering, Prototype or Programming personnel.

Knowledge: Complete understanding and application of principles, concepts, practices, and standards.

Reasoning Ability: Develops solutions to a variety of complex problems. Work is performed under minimal direction.

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.
• Advanced CAD software skills required.
• Ability to create complex, new RPi and PLC programs.
• Proficiency in drafting process specific Master Validation Plans.
• Proficiency in drafting and executing complex engineering study protocols.
• Ability to use project management tools to plan projects.
• Ability to prepare a capital equipment budget and justification.
• Ability to communicate ideas, results, recommendations, and status effectively.
• 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.

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.

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.

Vision Requirements: Visual acuity necessary to do the job safely and effectively.

Benefits:

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans
• 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 Time Off
• 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 or protected veteran status.

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Orlando FL United States

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