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Manufacturing Engineer I

Company: Ortho-Clinical Diagnostics
Location: Rochester
Posted on: June 8, 2021

Job Description:

The Career Potential

Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.

Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

The Opportunity

As the company continues to grow we are seeking a Manufacturing Engineer I. The Manufacturing Engineer would be the primary technical support for all changes initiated by the contract manufacturer of medical diagnostic equipment. They provide the technical input to change requests from the contract manufacturer working with cross-functional teams including: R&D, Quality Engineering, Field Service Teams, Procurement, Manufacturing, and Environmental/Safety. The Manufacturing Engineer will conduct detailed analysis of requests and provide guidance, assistance, and technical solutions to facility the change. This individual will track all changes, attend obsolescence meeting, process non-conformances, review incoming inspection plans, work directly with external suppliers, review work instruction, troubleshoot part problems, and fixture repairs. This person is also a support for part quality issues that may occur at the supplier, the manufacture, or at the customer's site.

This position is located in Rochester, NY.

The Responsibilities

  • Drives the disposition and change requests from contract manufacturers that includes R&D and Quality.

  • Review specification variance packages for completeness for processing in Ortho's Quality and Change Control systems.

  • Interact with supplier as needed on specification variances and obtain crucial prioritization.

  • Have ability to put together a presentation for each change request.

  • Understand the Quality Tracking System to process any accepted Spec variances as the change is processed, and tasks are completed and closed in the quality record.

  • Provide Red-lines to drawing changes until supplier can adequately provide red-lines.

  • Interact with RoHS team to ensure certificates are adequate for Ortho's Quality and Change Control systems.

The Individual

  • BA/BS with <2 years experience or MS with no experience. May include entry-level engineering training or internship.

  • Entry level, learning routine and typical aspects of the engineer role.

  • Basic understanding and application of standard Engineering/Manufacturing theories, concepts, principles and techniques in one of the following engineering disciplines: Electrical, Manufacturing Engineering.

  • Able to use standardized test equipment to solve a variety of basic technical problems related to the development, testing, calibration, validation and maintenance of experimental, prototype and existing laboratory and manufacturing equipment.

  • Knowledge of emerging technology trends.

  • Uses deductive reasoning to solve a variety of basic engineering problems related to calculations, tests, and design details.

  • Capable of tracking a plan for a small project. Uses available tools to organize desk, calendar, and daily tasks.

  • Written and verbal communication is clear and concise. Works with management to select the appropriate media for the target audience.

  • Should have an awareness of some Process Excellence tools.

  • Ability to work well within the team environment. Should be able to follow direction from team leaders for deliverables. Sphere of influence is limited to the members of a project team.

  • Determines root cause and implements practical solutions to component-level problems. Example problems: Tolerance Analysis, Component obsolescence (simple substitution).

  • Required Travel 5% domestic or international.

Keywords: Ortho-Clinical Diagnostics, Rochester , Manufacturing Engineer I, Other , Rochester, New York

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