|Reference # :||19-07474||Title :||Medical Device Manufacturing Engineer II|
|Location :||Irving, TX|
|Experience Level :||Start Date / End Date :||05/27/2019 / 12/31/2019|
|Job Title: Medical Device Manufacturing Engineer II|
Location: Irving, TX
Duration: 6+ Months of Contract
This position will primarily focus on developing, executing and closing Facility and Utility Qualifications for different areas like Manufacturing, Laboratory, Warehouse, etc. It will also cover Facility and Equipment drawings review, equipment IQ/OQ qualification support.
This position will primarily focus on developing, executing and closing Facility and Utility Qualifications for different areas like Manufacturing, Laboratory, Warehouse, etc.
It will also cover Facility and Equipment drawings review, equipment IQ/OQ qualification support.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
• System Validation Focus, writes and execute Facility and Utilities Qualifications and Final reports.
• Works with manufacturing managers, supervisors, and other engineers in developing, evaluating, and improving manufacturing methods by utilizing knowledge of product design, raw materials, tooling and production equipment capabilities, assembly methods, and quality control standards.
• Analyzes and helps plan resource capacity and utilization, defines work space requirements, workflow, designs layout of equipment and work space for maximum efficiency.
• Collaborates with production managers and supervisors to help estimate production times, staffing requirements, and related costs necessary for strategic and budgetary decisions.
• Confers with management, engineering, and other staff regarding manufacturing capabilities, production schedules, and other considerations to facilitate production processes.
• Conducts research to develop and introduce improved manufacturing methods. Analyze assembly processes to ensure desired results are achieved and sustained. Analyzes data to determine return on investment.
• Works with production personnel to establish or revise work instructions and procedures used in the production environment.
• Participates in the process of identifying and qualifying new production equipment, work stations / systems and test fixtures.
• Represents the operations group in projects to ensure manufacturability and serviceability is incorporated into a design plan.
• Maintains the design of released products with the goal of continuously improving quality, customer satisfaction, efficiency of production and cost effectiveness
• Follow corporate and governing body guidelines, manage projects.
• Works with the safety coordinator to perform hazard analysis on new equipment and systems to insure safe working conditions.
• Establishes validation protocols related to assembly processes.
• Builds productive working relationships.
• May provide assistance to junior level staff with general tasks that require a better understanding of functions, as directed by immediate supervisor.
• May refer to senior level staff for assistance with higher level problems that may arise.
• Escalates issues to supervisor/manager for resolution, as deemed necessary.
• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
• Assist with various projects as assigned by direct supervisor.
• Other duties as assigned.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
The physical demands and 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.
• Occasionally lift and/or move up to 50 pounds with assistance.