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Senior Manufacturing Engineer - Packaging in Ave Maria, FL ,  at Arthrex

Date Posted: 10/5/2018

Job Snapshot

Job Description


Requisition ID:
38382
Title:
Senior Manufacturing Engineer - Packaging
Division:
Arthrex Manufacturing Inc
Location:
Ave Maria, FL

Main Objective:

Design, develop, and implement automated device assembly, packaging, and labeling processes to produce cost effective quality medical device products and systems. Provide manufacturing engineering expertise to create, document and implement required procedures and documents.
 

Essential Duties and Responsibilities:

Drive automation to replace manual inspection, assembly, and packaging/labeling processes.
Work with project teams to identify issues and risks and propose corrective actions.

During new product development, represent the Packaging Production Department to ensure cost effective new product 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.

Lead/support process improvement initiatives, identifying best practices.

Introduce new fixtures, equipment, and processes. Present process and equipment recommendations to Leadership Team with plans for implementation. Manage automation equipment related capital projects with outside suppliers to meet project scope, cost, and schedule. 

Develop an understanding of the current final device assembly and packaging processes and identify targets for improvement in operation efficiencies.

Develop manufacturing Work Instructions, Inspection Plans, and Statistical Process Controls.

Provide process and equipment expertise and support for daily clean-room production and sterile packaging efforts.

Develop action plans to achieve short and long-range efficiency goals, selection of new production methods, designs of production fixtures, and methods to monitor efficiencies.

Lead and/or assist with implementation of packaging design/and or production specifications into manufacturing.

Monitor timelines and project deliverables to ensure adherence with approved project plans for production process development.

Develop protocols and coordinate validation of equipment and processes.

Stay current with methods used in the medical device industry to advance technologies.

Participate in defining Preventive Maintenance programs for clean room equipment/ and or production equipment.

Ensure Information and documentation is consistently accurate.

Analyze and plan workforce utilization, space requirements, and Lean workflow, layout of equipment and workspace for maximum efficiency.

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.

Estimate production times, staffing requirements, and related costs to provide information for management decisions.

Apply statistical methods to estimate future manufacturing requirements and potential constraints.

May supervisor other Engineering, Technician, Validation support personnel.

Incidental Duties:

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 (Industrial, Manufacturing, or Mechanical) 
7+ years of manufacturing process improvement experience.
Proven experience in leading process improvement projects.
Medical device manufacturing or FDA regulated environment preferred.
Experience in work flow optimization, work measurement, efficiencies.
Recognized process improvement training (Lean, Six Sigma) preferred.

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.

Thorough understanding of manufacturing processes.
Detail oriented with strong analytical skills.
SPC (Statistical Process Control) knowledge.
Strong communication skills and ability to communicate effectively with technical and non-technical staff.
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.
Familiarity with clean room practices preferred. 
Strong project management skills with proven ability to take a project from start to completion independently

Machine, Tools, and/or Equipment Skills:

Laser Marking, Bonding, cleaning equipment, finishing equipment, printing equipment, sealing equipment, pick and place, vision systems, and custom fixturing (Poke Yoke). 
 

Reasoning Ability:

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.

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 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.

Vision Requirements:

Visual acuity necessary to do the job safely and effectively.

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. 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.