Manufacturing Engineer II

Manufacturing Engineer II, Fresenius USA Manufacturing, Inc., a Fresenius Medical Care N.A. company, Oregon, Ohio

Purpose and Scope:

Responsible for identifying, implementing, monitoring and reporting on the impact of continuous improvement concepts that will utilize lean manufacturing principles. These improvements target manufacturing and industrial processes and procedures that will enhance the quality of repeatability of the assembly process and increase productivity.

Principal Duties and Responsibilities:

• Working 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.
• Analyzing and helping plan resource capacity and utilization.
• Defining workspace requirements, workflow, design layout of equipment and workspace for maximum efficiency.
• Collaborating with production managers and supervisors to help estimate production times, staffing requirements, and related costs necessary for strategic and budgetary decisions.
• Conferring with management, engineering, and other staff regarding manufacturing capabilities, production schedules, and other considerations to facilitate production processes.
• Conducting research to develop and introduce improved manufacturing methods.
• Analyzing assembly processes to ensure desired results are achieved and sustained.
• Analyzing data to determine return on investment.
• Working with production personnel to establish or revise work instructions and procedures used in the production environment.
• Participating in the process of identifying and qualifying new production equipment, workstations, systems, and test fixtures.
• Representing the operations group in projects to ensure manufacturability and serviceability is incorporated into a design plan.
• Maintaining the design of released products with the goal of continuously improving quality, customer satisfaction, efficiency of production and cost effectiveness.
• Following corporate and governing body guidelines while managing projects.
• Working with the safety coordinator to perform hazard analysis on new equipment and systems to insure safe working conditions.
• Establishing validation protocols related to assembly processes.
• Providing assistance to junior level staff with general tasks that require a better understanding of functions.
• Escalating issues to supervisor/manager for resolution, as deemed necessary.

Education Experience and Required Skills:

Position requires a Bachelor’s degree in Industrial, Mechatronic or Mechanical Engineering or a closely related field and 2 years of experience as a Manufacturing Engineer or a Product Engineer in the medical device sector.  Must also have had 2 years of experience (which can have been gained concurrently with the primary experience requirements above) working with the following:

• Creating, following-up on and implementing engineering changes and deviation/waiver processes;
• Configuring and managing Bills of Material, technical specification and engineering drawings;
• Development and implementation of manufacturing documentation including SOPs and equipment operational instructions;
• AutoCAD, Solidworks, or similar applications;
• Allen Bradley PLC including RSLogix 500 and 5000;
• Qualification and validation process to ensure compliance with quality systems, regulations and international standards for medical devices; and
• Project management, process control.

Employer will accept any qualified combination of education, training and/or experience.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.