Sr Manager R&D;, Systems Engineering – SpecialistJOB SUMMARY Senior Manager of Systems Engineering leads theorganization in innovative systems approaches to both technicalsolutions and product develop processes. Duties include assigningwork and mentoring direct reporting System Engineers (Lead SystemEngineers / Lead System Designers) in their Systems Engineeringtasks, including design and development, verification andvalidation testing, and investigations/root cause determinations. Responsible for the development of solutions to problems of highcomplexity and broad company implications. ESSENTIAL DUTIES -Manages and provides leadership and mentorship for the functionalgroup’s development, direction, and effectiveness, adhering toorganizational policies and processes and supporting overallbusiness and corporate objectives. - Subject Matter Expert to guideprojects and mentor other System Engineers on multiple of thefollowing areas: - Systems Engineering, Model Based SystemsEngineering - Requirements Writing and Traceability - IntegrationPlanning and Execution - Testing methodologies for verification andvalidation, product changes, and investigations - Risk Management,especially FMEAs for Design - Design Controls - Drives systemengineering principles through robust engineering processes withinteam and cross-functional counterparts. - Builds strong connectionswith functional counterparts to identify issues early and drivesolutions with our optimal considering the whole system. -Participates in the short - and long-term planning process thatestablishes technical objectives for a business unit project orfunctional engineering group. - Utilizes technical, managerialexpertise and creativity to evaluate proposed solutions,adaptations, and modifications to processes, projects, and productsused globally. - Drives engineering excellence in produce designtransfer to manufacturing, procedure, and service. - Identifiesproject, product opportunities and initiates prioritization inaddition to implementation. - Completes annual department budgetingand accountable for long range planning. - Implements andunderstands FDA and global regulatory requirements as necessary. -Ensures compliance with company Quality System regulations and safeworking practices. - Demonstrates broad management experienceacross and recognized as an expert within and outside of theCompany with fully developed leadership skills and a deepunderstanding of a broad issues vital to the company working withmultiple functions that are unrelated. - Uses systems thinking todesign complex platforms integrating equipment, software, anddisposables, achieving functional and reliability goals. - Defineintegration and verification plans, defining adequate resources andtime for execution of the plans. OTHER DUTIES AND RESPONSIBILITIES - May work with manufacturing and other functional groups onmanufacturing and regulatory compliance issues. - Performs othertasks at managers request to ensure the success of project and theoverall business. MINIMUM QUALIFICATION REQUIREMENTS Education -Bachelor’s degree or equivalent of education and experiencesufficient to successfully perform the essential functions of thejob may be considered. - Bachelor of Science Degree in Engineering,preferred. Experience - Minimum 15 years experience, 3 yearsmanaging others. - Minimum 5 years experience in most if not all ofthe following area: - Systems Engineering, Model Based SystemsEngineering - Requirements Writing and Traceability - IntegrationPlanning and Execution - Testing methodologies for verification andvalidation, product changes, and investigations - Risk Management,especially FMEAs for Design - Design Controls - Successfulexecution in most if not all of the following areas: - Engineeringproduct development such as requirements/specification development,risk management, verification and validation or other systemsengineering processes. - Experience in both systems engineering andsoftware engineering. - Technical investigations and CAPA. -Regulatory inspections. - Manufacturing and supplier specificationdevelopment. - Statistical tools – Statistical Process Control,Sampling, Design of Experiment. Skills - Change leader whoidentifies opportunities and then designs and implements solutionto capitalize on those opportunities. - Exceptional engineeringskills and strong commitment to a rigorous process approach toengineering. - Demonstrated ability to lead a multi-disciplineengineering and scientific team both as a direct leader and viainfluencing. - Skilled ability to balance commercial anddevelopment needs to accomplish global business area goals. -Advanced understanding and application of Engineering Processes andQuality Management System applied to product development, transfer,and manufacturing. - Broad knowledge of engineering, management,quality, global regulatory standards, and/or manufacturing. -Ability to quickly gain working knowledge of the business'sproducts and therapeutic uses. - Effective leadership, managerial,and strategic planning skills. - Requires an exceptionalunderstanding of technology and methods applicable to the area andthe ability to determine appropriate application. - Knowledge anduse of relevant PC software applications and skills to use themeffectively. - Demonstrated ability to communicate effectively bothverbally and in writing. #J-18808-Ljbffr Engineering