Vacancy expired!
Available Openings 1Purpose and Scope:Fresenius USA, Inc. has two (2) open positions for a qualified Senior Manufacturing Engineer.This position will ensure that all manufacturing related aspects of the company products are addressed throughout the product development cycle. The position will work closely with engineering, quality, and manufacturing operations to support the manufacturing of current and next generation products and improve manufacturing processes.Principal Duties and Responsibilities:
Develops and maintains the documentation necessary to ensure the consistent manufacture of products (processes, drawings, and shop floor paperwork).
Analyzes and plans resource capacity and utilization, defines workflows and designs layout of equipment and work space for maximum efficiency.
Provides engineering support for troubleshooting efforts for any process issues in designated area. Summarizes and draws conclusions from test results leading to effective technical resolution of process problems.
Ensures design for manufacturing elements are incorporated into new product development activities and represents the Operation Group to ensure that concepts of manufacturability and serviceability are incorporated into the design plan.
Identifies, justifies, and implements multiple significant data driven projects to reduce manufacturing costs, improve processes, increase product reliability, and enhance process capability.
Designs, evaluates and qualifies new and existing production equipment, fixtures, work stations and systems, test methods, specifications, layouts, and standards.
Collaborates with manufacturing staff and management in other disciplines to develop, evaluate, and improve manufacturing methods.
Analyzes assembly processes to ensure quality results are achieved and sustained. Analyzes data to determine return on investment.
Works with production personnel, suppliers and contract manufacturers to establish or revise work instructions and production procedures.
Ensures quality outcomes in device manufacturing areas by working with suppliers, quality systems, procurement and sustaining engineering.
Performs hazard analysis on new equipment and systems to insure safe working conditions.
Establishes validation protocols related to assembly and test processes.
May escalate 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.
Education Experience and Required Skills:Position requires a Master’s degree (or an equivalent foreign degree) in Industrial, Electrical or Manufacturing Engineering and 1 year of experience as a Manufacturing Engineer. This experience must include working with: (i) the FDA design control process; (ii) verification and validation testing design and implementation for the manufacture of medical device products; (iii) failure mode and effects analysis; (iv) CAPA initiation and failure analysis; and (v) development and qualification of tooling/equipment (IQ/OQ/PQ, support, design).
Vacancy expired!