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Senior Manufacturing Engineer

Company: Ortho-Clinical Diagnostics
Location: Rochester
Posted on: June 7, 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 Senior Manufacturing Engineer. The Senior Manufacturing Engineer will be deployed to assist New Product Introduction (NPI) programs to ensure flawless execution of Design Transfer activities and the successful operational implementation of manufacturing processes at both internal and external Electro Mechanical manufacturing partner sites. The individual will partner with R&D teams through the design phase to ensure operational and supply chain requirements are understood by the project team in addition to the early identification of product and/or manufacturing requirements that need development of new manufacturing capabilities and/or competencies. The role will involve collaboration with both external component suppliers, external manufacturing sites and internal manufacturing sites as design specifications received from the R&D design team are translated to supplier and manufacturing specifications.

This position is located in Rochester, NY.

The Responsibilities

  • For NPI and LCM Programs, work closely with R&D, Quality, and Ortho Care, leading team activities to resolve manufacturing issues identified through Specification Variance (SV) and Supplier Change Request (SCR) processes.

  • For NPI and LCM Programs, the Senior Manufacturing Engineer will be responsible for part and assembly qualification, utilizing Production Part Approval Process (PPAP) data provided by the external manufacturing partner, and collaborating with Ortho R&D, Quality, and Ortho Care to provide Ortho approval.

  • For NPI Programs, ensure flawless execution of Design Transfer activities and the successful operational implementation of manufacturing processes at both internal and external Electro Mechanical manufacturing partner site.

  • For LCM and new programs, the individual will be responsible to review drawing and make recommendations for cost reduction opportunities. The engineer will also be responsible to drive drawing changes in the PLM system.

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

  • Provide technical resources to manufacturing related fixtures located at external suppliers.

The Individual

  • BA/BS with 6-10 years experience or MS with 5-7 years experience in Mechanical Engineering or equivalent technical degree.

  • The products primarily supported by this position will require an electromechanical device process development engineering skill set.

  • A broad-based knowledge of assembly and component manufacturing processes within the Diagnostics and/or Medical Device Industry is preferred.

  • Demonstrated ability to lead, under minimal oversight, elements of complex technical projects confidently is strongly preferred.

  • Experience in an FDA regulated and/or GMP environment is preferred.

  • This position requires someone with very strong communication (both written and verbal) as well as influencing skills as interaction with multiple functions and various suppliers is required.

  • Experience in process improvement efforts using Process Excellence, Six Sigma and Lean Tools is preferred.

  • Proficiency with Microsoft Office is required.

  • Knowledge of Product Data Management tools (PDM) is preferred.

  • Proficient in reading and interpreting GD&T, tolerance analysis.

  • Coach less experienced engineers in process/design changes. Lead by example when completing daily work. Work within the team dynamic to promote Win-Win solutions to problems. Ownership and accountability to project results is clearly demonstrated.

  • Required travel 5% domestic or international.

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

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