Systems Engineer II

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 Systems Engineer II.This individual will conduct and manage technically challenging systems-type investigations to address on-market product quality issues and recommend solutions.

Collaborating cross-functionally across Ortho, and with customers, they will use data analytics to drive scoping of investigations and decision making. They will use technical knowledge of electro/mechanical/software systems and scientific principles of how assays work to design, conduct and document experiments to systematically identify failure mode/s and establish root cause/s. This position is located in Rochester, NY.

The Responsibilities

• Assess failure modes of potential quality issues of systems nature related to hardware/software, reagents, samples, testing protocol and consumables reported by customers and internal stakeholders.
• Perform investigation into the product issue/s to understand nature of the problem.
• Work with cross-functional representatives in quality, customer support, lifecycle management team, operations and our development partners, to define the problem and deviation from intended performance.
• Collect and analyze data from instruments and databases. Use knowledge of data analytics and statistics to discern significant trends to assess contribution of potential root causes.
• Design and conduct experiments to determine root cause either as sole investigator for small-scale and/or large investigations, or as part of a team to support large-scale investigations.
• Propose corrective actions for implementation to fix product issues.
• Document and maintain investigation records and findings.
• Communicate investigative findings to the Customer Service Organization in a way that enables broad dissemination and actionable use of technical knowledge.
• Complete Quality System records in conjunction with product investigations.
• Operate equipment in a biohazard lab environment.
• Communicate with an international community of technical support staff.
• Seek technical information and engender collaboration from development partners, inside/outside Ortho and outside the US.
• Learn the operating principles and detailed engineering features of complex electro/mechanical/software systems and scientific principles of how assay work.
• Occasional travel.
• Performs other work-related duties as assigned.

The Individual

• Minimum of 3 progressive years of experience with a Bachelor's degree in Engineering or related scientific discipline. Systems, Mechanical, Electrical, Chemical or Biomedical Engineering preferred and/or equivalent combination of education and experience.

• Ability to triage product issues and perform root cause investigations required.
• Experience with clinical chemistry and/or immunohematology systems preferred.
• Systems thinking acuity and a keen interest in diving deep into complex product issues and learning different technologies required.
• Experience in application of design of experiments to an industry setting required.
• Demonstrated ability in technical analysis and evaluation of data required.
• Ability to have a customer-oriented mindset to better anticipate needs, resolve issues more quickly and ultimately create a better user experience required.
• Ability to work well in a team environment required.
• Excellent organizational skills required.
• Excellent communication, influencing and conflict resolution skills required.
• Experience with technical writing and English fluency required.
• Ability to adapt quickly to obstacles and changing demands required.
• Six Sigma and/or Kepner-Tregoe background preferred.
• Background in applied statistics preferred.
• Experience with MATLAB and/or other programming/scripting languages preferred.

Key Working Relationships:

Internal: Field Triage Team (of which this job is part), Development Team (for translating proposed solutions into actual designs), Quality (for compliance process), Operations (for deep subject matter expertise of manufacturing processes), Ortho Care (for seeking additional information, and for communicating findings).

External: Development Partners and Suppliers (for deep investigational and raw materials assistance, and for translating proposed solutions into CAPA), Customers (for additional information related to investigations).

Key Supervisory Responsibilities:

Makes hiring recommendations, Trains employees, Plans work of others, and Reviews work quality and quantity of others.

EOE/AA Disability/Veteran

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