Accreditation Council for Graduate Medical Education
Principal Advanced Manufacturing Engineer - Mechanical - Ave Maria, FL. (Packagi
Accreditation Council for Graduate Medical Education, Ave Maria, Florida, United States
Overview
Requisition ID: 63860 Title: Principal Advanced Manufacturing Engineer - Mechanical - Ave Maria, FL. (Packaging) 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 seeking a Principal Advanced Manufacturing 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. The role leads the mechanical design and fabrication of custom semi-automated or fully automated manufacturing equipment, tooling and fixturing, and implements mechanical design solutions to improve safety, quality, and efficiency of manufacturing processes. First Shift
- Monday–Friday, 8:00am–5:00pm
Essential Duties and Responsibilities
Support a customer-focused culture by identifying key customer/user requirements and translating those into functional and design specifications during the design of custom equipment and fixturing.
Support a continuous improvement culture to enhance safety, quality, delivery, and cost by employing Lean/Six Sigma continuous improvement tools in all projects.
Support a highly innovative culture by identifying novel/first-of-a-kind solutions, and applying lessons learned through successes and failures.
Support a fast-paced, accountable, teamwork culture by completing project tasks on-time, identifying potential roadblocks, and effectively communicating status, escalating issues as needed.
Support new product development, design transfer, and continuous improvement (Kaizen) projects as the subject matter expert for equipment mechanical design and fabrication.
Maintain compliance with Safety requirements related to ergonomics (human-to-machine interface) and guarding.
Maintain compliance with Medical Device Quality System requirements related to equipment validation.
Design and develop mechanical design solutions for custom automation or semi-automated equipment or fixturing.
Design and develop custom poka yoke, Go/No-Go, and inspection gauges/fixtures, and mechanical design of automated inline inspection and test systems for electro-mechanical medical devices.
Identify and evaluate the optimum mechanical design solutions and equipment components based on the latest available technology and industry best practices.
Develop capital equipment project scope, budget, milestones, and follow a structured Management of Change process.
Provide requirements to equipment vendors (OEMs) and review design and specification packages during equipment quotation.
Create and execute validation protocols and reports compliant with Medical Device requirements (IQ, OQ, PQ).
Create Equipment maintenance manuals, recommend Preventive Maintenance Plans, and spare parts.
Create operator work instructions and troubleshooting guides.
Lead Root Cause Investigations or equipment troubleshooting using structured problem-solving tools (Lean A3, Six Sigma DMAIC) and Statistical Analysis.
Lead process development or process improvement work using process Failure Mode Analysis (pFMEA) and structured Design of Experiments (DOE).
Ensure data and documentation are consistently accurate and complete and in compliance with Good Documentation Practices (GDP).
May supervise Technician, Engineering, Prototype or Programming personnel.
Education/Experience
B.S. in Engineering required
Minimum of 12 years experience in Design and Development or Manufacturing Engineering required
Proven experience leading process improvement projects
Proven experience leading new equipment, capital projects
Experience leading/supervising direct reports
Experience in medical device manufacturing or related health sciences industry preferred
SAP, MiniTab, SolidWorks experience preferred
Lean Six Sigma Green Belt / Black Belt certification preferred (repeat noted in original)
Skills
Expert knowledge of materials and machine design/function
Expert knowledge of emerging technologies and applying them to processes
Proficiency in Industry Standard (ASTM) test methods
Proficiency in ISO regulations and FDA 21 CFR Part 820 compliance, with ability to assess and mitigate risks
Expert proficiency with CAD/CAM software including revision control and file management
Demonstrated ability to design for Six Sigma and Lean Six Sigma
Proficiency in developing and auditing Master Validation Strategies and Plans for compliance
Proficiency in drafting and executing complex engineering study protocols, DOEs, data analysis, deviations, and reporting
Proficiency with project management tools (MS Project, MindView, Workfront) for large capital projects
Ability to supervise technicians, contractors, and engineers
Ability to innovate new design solutions for modifying existing equipment or designing fully custom equipment
Ability to identify information systems requirements to improve processes
Ability to manage process variation and parameters influencing outcomes
Knowledge, Reasoning, and Other Abilities
Regularly contributes to development of new concepts and standards. Full knowledge of industry practices and regulations; considered an expert in the field.
Reasoning: Develops design solutions to complex problems, establishes precedents and policies, and ensures alignment with organizational objectives.
Discretion/Latitude: Works autonomously, plans and schedules activities, and exercises latitude in approaches to assignments.
Work Environment and Physical Demands The work environment is typically a general office or open cubicle/workstation with reasonable accommodations. Physical demands include standing, lifting up to 20 pounds, and close work with tools and equipment. Vision requirements include close vision for microscope use.
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
Paid Parental Leave
Paid Time Off and Volunteer PTO
Employee Assistance Program
EEO Statement 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.
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Requisition ID: 63860 Title: Principal Advanced Manufacturing Engineer - Mechanical - Ave Maria, FL. (Packaging) 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 seeking a Principal Advanced Manufacturing 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. The role leads the mechanical design and fabrication of custom semi-automated or fully automated manufacturing equipment, tooling and fixturing, and implements mechanical design solutions to improve safety, quality, and efficiency of manufacturing processes. First Shift
- Monday–Friday, 8:00am–5:00pm
Essential Duties and Responsibilities
Support a customer-focused culture by identifying key customer/user requirements and translating those into functional and design specifications during the design of custom equipment and fixturing.
Support a continuous improvement culture to enhance safety, quality, delivery, and cost by employing Lean/Six Sigma continuous improvement tools in all projects.
Support a highly innovative culture by identifying novel/first-of-a-kind solutions, and applying lessons learned through successes and failures.
Support a fast-paced, accountable, teamwork culture by completing project tasks on-time, identifying potential roadblocks, and effectively communicating status, escalating issues as needed.
Support new product development, design transfer, and continuous improvement (Kaizen) projects as the subject matter expert for equipment mechanical design and fabrication.
Maintain compliance with Safety requirements related to ergonomics (human-to-machine interface) and guarding.
Maintain compliance with Medical Device Quality System requirements related to equipment validation.
Design and develop mechanical design solutions for custom automation or semi-automated equipment or fixturing.
Design and develop custom poka yoke, Go/No-Go, and inspection gauges/fixtures, and mechanical design of automated inline inspection and test systems for electro-mechanical medical devices.
Identify and evaluate the optimum mechanical design solutions and equipment components based on the latest available technology and industry best practices.
Develop capital equipment project scope, budget, milestones, and follow a structured Management of Change process.
Provide requirements to equipment vendors (OEMs) and review design and specification packages during equipment quotation.
Create and execute validation protocols and reports compliant with Medical Device requirements (IQ, OQ, PQ).
Create Equipment maintenance manuals, recommend Preventive Maintenance Plans, and spare parts.
Create operator work instructions and troubleshooting guides.
Lead Root Cause Investigations or equipment troubleshooting using structured problem-solving tools (Lean A3, Six Sigma DMAIC) and Statistical Analysis.
Lead process development or process improvement work using process Failure Mode Analysis (pFMEA) and structured Design of Experiments (DOE).
Ensure data and documentation are consistently accurate and complete and in compliance with Good Documentation Practices (GDP).
May supervise Technician, Engineering, Prototype or Programming personnel.
Education/Experience
B.S. in Engineering required
Minimum of 12 years experience in Design and Development or Manufacturing Engineering required
Proven experience leading process improvement projects
Proven experience leading new equipment, capital projects
Experience leading/supervising direct reports
Experience in medical device manufacturing or related health sciences industry preferred
SAP, MiniTab, SolidWorks experience preferred
Lean Six Sigma Green Belt / Black Belt certification preferred (repeat noted in original)
Skills
Expert knowledge of materials and machine design/function
Expert knowledge of emerging technologies and applying them to processes
Proficiency in Industry Standard (ASTM) test methods
Proficiency in ISO regulations and FDA 21 CFR Part 820 compliance, with ability to assess and mitigate risks
Expert proficiency with CAD/CAM software including revision control and file management
Demonstrated ability to design for Six Sigma and Lean Six Sigma
Proficiency in developing and auditing Master Validation Strategies and Plans for compliance
Proficiency in drafting and executing complex engineering study protocols, DOEs, data analysis, deviations, and reporting
Proficiency with project management tools (MS Project, MindView, Workfront) for large capital projects
Ability to supervise technicians, contractors, and engineers
Ability to innovate new design solutions for modifying existing equipment or designing fully custom equipment
Ability to identify information systems requirements to improve processes
Ability to manage process variation and parameters influencing outcomes
Knowledge, Reasoning, and Other Abilities
Regularly contributes to development of new concepts and standards. Full knowledge of industry practices and regulations; considered an expert in the field.
Reasoning: Develops design solutions to complex problems, establishes precedents and policies, and ensures alignment with organizational objectives.
Discretion/Latitude: Works autonomously, plans and schedules activities, and exercises latitude in approaches to assignments.
Work Environment and Physical Demands The work environment is typically a general office or open cubicle/workstation with reasonable accommodations. Physical demands include standing, lifting up to 20 pounds, and close work with tools and equipment. Vision requirements include close vision for microscope use.
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
Paid Parental Leave
Paid Time Off and Volunteer PTO
Employee Assistance Program
EEO Statement 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.
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