Manager Systems Integration

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.

About Abbott Diagnostics

Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis, and treatment of a range of health conditions.

Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. 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.

Our Hematology division currently has an opportunity for a Manager Systems Integration. This position is based onsite in Santa Clara, CA.

WHAT YOU’LL DO

The Manager of Systems Integration leads a team of scientists and engineers in defining, planning and executing integrated testing of complex medical device solutions. Plans and directs all aspects of systems integration activities and projects. Oversees the team approach to applying interdisciplinary systems engineering to design, development, and verification processes on system-level and sub-system level of medical devices. Ensures systems integration strategy and plan results in issue containment and flawless system verification execution, of both functional and performance requirements. Ensures all systems integration projects, initiatives, and processes are in alignment with business objectives and goals. Ensures team executes study protocols following good lab practices based on current industry guidance (CLSI) and Abbott quality standards.

Main Responsibilities

• Establish strategic plans, objectives, and deliverables for system integration including requirements, risk management, feasibility testing and verification testing.

• Performs resource planning and allocation. Coordinates the implementation of multiple projects across multiple disciplines. Ensures project milestones are met on time and within budget; mobilizes resources to address priorities within the department.

• Ensure appropriate laboratories and infrastructure are maintained to support the needs of R&D system integrated testing team (including service, reliability and verification).

• The manager of systems integration will have ownership for prototype instrument allocation, laboratory test planning and execution control, maintaining an audit ready lab at all times.

• Prepares and manages budgets: Establishes departmental; or project budgets; manages against approved budgets. Develops budget projections for capital equipment, lab improvements and lab materials. Responsible for ensuring consumable materials are available to maintain laboratory and testing operations.

• Builds an effective organization: Conducts resource management analysis, assesses and closes skill gaps to ensures alignment of competencies and capabilities to meet the strategic business needs. Staff is appropriately trained and developed to support current needs and emerging trends.

• Adapts Information to Customer Needs: Delivers communications tailored to the needs of the organization; balances detail versus summary style suitable for the audience. Makes Key Presentations: Delivers persuasive; and motivational presentations to influence employees; peers; regulatory agencies; and/or senior management. Articulates and translates department and/or functional strategy objectives.

• Lead process ownership and definition for system integration methods and procedures. Utilizes best practice systems integration methods: Provides expert technical guidance for systems integration initiatives. Ensures systems design and documentation meet all safety and regulatory compliance.

• Develops and monitors quality assurance processes: Includes efficiency, productivity, completeness, accuracy of clerical functions and other non-analytical laboratory functions. Responsible for implementing and maintaining the effectiveness of the quality system.

Minimum Requirements

• Bachelors degree and 4 years experience (8 + years preferred)

Preferred Qualifications

• Hematology product development or lab experience including emphasis on contriving whole blood specimens preferred

• Experience in managing a clinical laboratory, maintaining and running diagnostic medical equipment

• Experience with statistical planning, analyzing data, evaluating results and forming conclusions in technical reports

• Experience through full product development cycle of complex electromechanical systems, from initial concept to release to market

• Knowledge of regulations and standards affecting in vitro medical device development including Quality, Technical, Regulatory, and Manufacturing

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• Training and career development, with onboarding programs for new employees and tuition assistance

• Financial security through competitive compensation, incentives, and retirement plans

• Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs

• Paid time off

• 401(k) retirement savings with a generous company match

• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

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Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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