Requisition ID: 34041 Title: Sr. Engineer, Packaging - Lab/Ops Division: Arthrex Manufacturing Inc (US02) Location: AMI East- AMI- Ave Maria, FL (US05)
Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. We are looking for a Senior Engineer to join our growing Packaging team who is self-motivated and has proven experience in leading process improvement projects. This person will be responsible for day to day operations along with laboratory testing and supervision. New process development will also be a focus for this role.
If you have strong desire for a new opportunity in the Medical Device industry, take a further look at the description below to see if this is career path for you.
Responsible for the daily operation of the Packaging testing laboratory. Activities include: Laboratory testing equipment operation, protocol execution, and Packaging Lab Tech/test supervision. Provide engineering expertise to create, document and implement required procedures and documents.
Essential Duties and Responsibilities:
- Write and execute engineering studies/DOEs, validation IOQ/PQ protocols, gage R&Rs for packaging test equipment processes, tools/fixtures, and test/inspection equipment.
- Conduct and document package dynamics and unit package testing for process and design validations and provide design inputs.
- Establish Test Technician Certification process.
- Provide Test Lab Technician training, certification, and supervision.
- Ensure that the Packaging Lab remains clean, organized, and in a validated state.
- Stay current with ASTM/ISTA/ISO/FDA and internal quality assurance policies.
- Stay current with methods used in the medical device industry to advance packaging and testing technologies.
- Identify, recommend and assist with process/equipment improvements for set-ups and test methods. Write and revise work instructions, procedures, and forms as required.
- Provide communication of test status and provide feedback on issues found within tests and tasks to Packaging Engineering Supervisor and Packaging Design teams.
- During new product development, represent the Packaging Production Department to ensure cost effective new product packaging development and introduction into production assuring Design for Manufacturing (DFM).
- Develop a continuous improvement culture, skills sets and tools to enhance quality and operational excellence. Work with project teams to identify issues and risks and propose corrective actions.
- Lead/support process improvement initiatives, identifying best practices.
- Recommendations to Leadership Team with plans for implementation.
- Develop manufacturing Work Instructions, Inspection Plans, and Statistical Process Controls.
- Lead and/or assist with implementation of packaging design/and or production specifications into manufacturing.
- Conduct risk assessments, develop protocols and coordinate validation of packaging production test equipment and inspection processes.
- Participate in defining Preventive Maintenance programs for test lab and packaging production inspection fixtures and equipment.
- Analyze and plan test lab utilization, space requirements, and Lean workflow, layout of equipment and workspace for maximum efficiency and material controls.
- Confer with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluates products according to specifications and quality standards.
- Apply statistical methods to estimate future manufacturing requirements and potential constraints.
- May supervisor other Engineering, Technician, Validation support personnel.
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
- Bachelor’s degree required; preferably in Engineering or Technology (Industrial, Manufacturing, Packaging, or Mechanical)
- 7+ years of manufacturing or packaging process improvement experience required.
- Proven experience in leading process improvement projects required.
- Medical device manufacturing or FDA regulated environment preferred.
Experience with medical packaging test methods and ASTM/ISTA packaging dynamic testing strongly preferred.
- Experience in material conditioning / accelerated aging desirable.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
- Ability to work independently and effectively with cross functional teams.
- Strong interpersonal and verbal/written communication skills and ability to communicate effectively with technical and non-technical staff.
- Thorough understanding of manufacturing processes. Recognized process improvement training (Lean, Six Sigma) preferred.
- Detail oriented with strong analytical skills.
- SPC (Statistical Process Control) knowledge.
- Experienced user of MS Office Suite, SPC Software, and CAD.
- Experience with planning and conducting tests to validate equipment and processes.
- Experience in completing technical documentation for engineering and manufacturing.
- Strong project management skills with proven ability to take a project from start to completion independently.
Machine, Tools, and/or Equipment Skills:
Vibration Tables & Controls, Compression Testers, Drop Testers, Burst Test Equipment and Fixtures, Tensile Testers, Dye Penetration & Bubble Emission Equipment, Gurley Testing, O2 Detection, Package Heat Sealing equipment, Gas Flush Systems, Vision Inspection Systems, SPC Data Collection, and custom test fixtures, etc.
Ability to define problems, collect 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.
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.
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 sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. To bend frequently and lift 30 lbs on a regular basis.
Visual acuity necessary to do the job safely and effectively.
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. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock. 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.
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