Sr Manager Systems Integration

AbbottIrving, TX
Onsite

About The Position

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Senior Manager, Systems Integration works out of our Irving, TX location in the CoreLab business, part of Abbott Diagnostics . We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. This role will drive technical excellence, affordability, and program execution by supporting program development, execution of program requirements, adherence to engineering development processes, promoting customer focus, and serving as the technical conscience for their program. Ensure technical integrity of the work products from group. Serve as a catalyst for staff by inspiring constructive exploration and experimentation in ways of improving delivery, user experience and business outcomes.

Requirements

  • Bachelor’s Degree required in systems engineering, life sciences, or related engineering discipline from an accredited college or university AND 12+ years of applicable experience; OR Master’s Degree in systems engineering, life sciences, or related engineering discipline from an accredited college or university AND 9+ years of experience
  • Minimum 10 years of relevant experience
  • Minimum 4 years of proven managerial experience with cross functional technical teams with the ability to adapt well to fast-paced environments with changing circumstances, direction, and strategy.
  • 5+ years of work experience in a federal regulated environment and 4+ years of project management experience.
  • Strong interpersonal, communication and negotiation skills necessary to develop and maintain smooth, cooperative working relationships with all levels of management and to drive change across business functions.
  • Proven ability to negotiate, troubleshoot, assess, remediate; and ability to make sound decisions and complex tradeoffs to successfully drive on-time delivery of complex electromechanical systems from initial concept to market release.
  • Expertise in systems integration deliverables including system verification and validation (V&V) test plan/protocols, executing V&V activities, and generating and analyzing test reports.
  • Expertise in system level failure and root cause analysis to include experience developing and executing integration test plans with significant software components and regression testing.
  • Demonstrated technical leadership and issue ownership, systems engineering architecture principles and concepts knowledge, and expertise in Product Risk Management best practices and tools.
  • Demonstrated knowledge of regulations and standards affecting in vitro medical device systems, Quality, Technical, Regulatory, or Manufacturing areas within the pharmaceutical or device industry with proficiency to identify appropriate product risks.

Responsibilities

  • Plans and directs all aspects of systems integration activities, applying interdisciplinary systems engineering to design, development, and verification processes on system and sub-system levels.
  • Ensures verification and validation (V&V) strategy and plan results in end-to-end traceability of functionality and product performance requirements, and tracking of systems and subsystem requirements and specifications.
  • Sets technical direction for systems requirements management (i.e. risk management traceability, verification testing and design, etc.) providing technical expertise and guidance to the team and peers; accurately evaluate and assess complex processes, identifying solutions and making sound decisions.
  • Successfully drive on-time delivery of project execution for complex products and system performance.
  • Establishes and executes plans to support regulatory requirements related to supported products.
  • Oversees multiple laboratories with equipment compliant to Good Laboratory Practices and ensuring capacity and supplies support strategic objectives.
  • Be personally accountable for ensuring collaborative relationships with Product Management, Program/Project Management, other Hardware/Software functional groups, Quality/Regulatory functions, Operations and Commercial groups, etc.
  • Work across functions with peers in other groups to ensure collaboration for shared goals; coordinate requirements, perform risk analysis and systems testing to ensure customer expectations are being met.
  • Demonstrate excellence in customer relations, internally and externally.
  • Performs resource planning and allocation.
  • Performs resource management analysis and ensures alignment of capabilities to meet the strategic vision and needs of the business.
  • Identifies and ensures appropriate utilization of the tools needed to close skill gaps appropriate for current and emerging trends related to the discipline.
  • Staff is appropriately trained and skilled individuals are identified to meet the needs of the business.
  • Ensures appropriate laboratories and infrastructure to support the needs of staff.
  • Responsible for staff development and workforce planning.
  • You will ensure team compliance with legal and regulatory issues in such areas as products and services, workplace safety and contractor relationships, and training.
  • Provide technical coaching and mentoring, employee career development, continuous ongoing feedback, and being their employees advocate for growth and opportunity.
  • Ensure team understands their jobs and how they will be measured against performing their jobs satisfactorily.
  • Serves as a channel for company communications.
  • Disseminate corporate, division, and site-related information to direct reports.
  • Engage with direct reports weekly.
  • Communicate financial and goal results, and key performance indicators.
  • Delivers presentations to influence peers, regulatory agencies, and/or senior management.
  • Articulates and translates department and/or functional strategy objectives and deliverables.
  • Develops and monitors efficiencies, productivity, accuracy of clerical and other non-analytical laboratory functions.
  • Ensures systems design and documentation meet all safety and regulatory compliance.
  • Risks judgement and guidance directly affect the organization’s ability and success in attaining suitable compliance profiles for world-wide regulatory agencies: FDA, ISO, EU, etc. and product safety.

Benefits

  • Career development with an international company where you can grow the career you dream of.
  • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • An excellent retirement savings plan with a high employer contribution.
  • Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
  • A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
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