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.
R&D Systems Engineering Center of Excellence is forming within the R&D Clinical Laboratory Platforms & Systems organization. We are expanding our System Engineering capability (both technical leadership and Systems Engineering SME), implementing standardized processes and infrastructure, and ensuring optimized execution of the product portfolio. We are strengthening our core and building upon our foundation of deep domain knowledge. This position is highly impactful and based in the Company’s R&D headquarters in Rochester, NY. This role offers the right candidate a unique opportunity to join a best-in-class systems engineering team to drive growth within our clinical chemistry and immunodiagnostics portfolio of products for Ortho.
We are looking for a Staff Systems Engineer to join our R&D Clinical Laboratory Platforms & Systems organization to provide technical leadership for the realization of a new / substantially evolved existing product/feature within our chemistry and immunodiagnostics portfolio of products. The individual should have an eye for creating custom engineering solutions and be well-versed in each stage of the R&D systems life cycle while driving results within the project constraints of schedule, cost, performance, quality and reliability objectives.
- Drives refinement/ translation of stakeholder requirements (Customer, safety, reliability, clinical, serviceability, manufacturability, quality etc.), requirements management policies of the program and quality of requirements, development of technical approach, top level design, feasibility of potential technical solutions, and allocation of derived requirements (including functionality, interface specifications and design budgets) onto affected subsystems.
- Evaluates systems and make recommendations for improvements and solutions
- Harmonizes common product features, system functions and improvement solutions across relevant products
- Works with a team to ensure projects are completed effectively and efficiently.
- Plans, oversees and executes the Systems Engineering activities in the project, including initiation, coordination, synchronization, review and integration of the technical work performed within various engineering disciplines with respect to supported subsystem(s).
- Leads cross-discipline feasibility and tradeoff studies.
- Drives subsystem-level design & technical reviews.
- Leads derivation/budgeting/allocation of system/subsystems requirements and interfaces.
- Leads defect management, risk management, usability activities
- Leads the preparation of documentation, including configuration documentation, DHF etc.
- Leads system integration (follow up, analysis, problem solving), verification and validation.
- Typically requires 7 – 9 years of experience with BS or equivalent, 5 - 7 years with MS or Ph.D. with 2 - 4 years of experience. Minimum five (5) progressive years of experience in Systems Engineering or minimum ten (10) progressive years of experience in capital equipment development.
- Three (3) plus year’s involvement in a multi-discipline project development environment.
- Three (3) plus years of engineering experience of complex systems in one area and deep understanding in a second one (SW/ EE/ME etc.).
- Demonstrated ability of advanced systems thinking skills
- Demonstrated ability in leading evolution of complex systems, where analysis requires both evaluation of multiple candidate solutions and significant evaluation of intangibles
- Ability to propose methods, techniques and evaluation criteria to obtain results
- Proven excellence in technical leadership in a matrix environment, including demonstrated ability to influence indirect resources.
- Excellent organizational skills
- Excellent communication, influencing and conflict resolution skills
- Excellent technical writing, and presentation skills; English fluency.
- Adapt quickly to obstacles and changing demands.
- Demonstrated ability in teambuilding, establishing common goals and working methods
- Operates through the entire system engineering process model
- Ability to think like our customers and have a service-oriented mindset to better anticipate needs, resolve issues more quickly and ultimately create seamless user experiences
- Six Sigma background
- Systems modeling background
- Ten (10) progressive years of experience in Systems Engineering
- Experience with Systems Engineering for medical devices
- Demonstrated experience in physics, mathematics, algorithms, optics, fluid dynamics