Associate Validation Engineer

Abbott Park, IL, United States

Job Description


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 115,000 colleagues serve people in more than 160 countries.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people\xe2\x80\x99s health. We\xe2\x80\x99re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You\xe2\x80\x99ll also have access to:

  • Career development with an international company where you can grow the career you dream of.
  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
  • An excellent retirement savings plan with high employer contribution
  • Tuition reimbursement, the
student debt program and education benefit - an affordable and convenient path to getting a bachelor\xe2\x80\x99s degree. * A company recognized as a great place to work in dozens of countries around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity

This position works out of our Abbott Park (Lake Bluff), IL Headquarters location in the Core Diagnostics Division. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

As the Validation Engineer, you\xe2\x80\x99ll be responsible for responsible for implementing and maintaining the effectiveness of the quality system. Completes professional level engineering assignments related to a specific field or discipline. Participates in projects involving the Design, fabrication, validation, and manufacture of complex instrument subassemblies, systems, or processes. You will be involved in preparing, drafting and execution of validation protocols. The incumbent ensures the assigned areas of Validation are effectively managed and all elements follow the requirements specified by Abbott Diagnostics Division Quality System and in the relevant international standards. This individual will participate in the design and development of automation engineering solutions.

What You\xe2\x80\x99ll Work On:
  • Develops Testing documents- Develops testing documents for new / modified equipment designs and performs engineering analysis and testing.
  • Implements the design of new equipment or process improvements - Implements the design for equipment or process changes and ensures designs meet established requirements through equipment and process qualification.
  • Responsible for updating / creating detailed design specifications.
  • Verifies Solution -Responsible for integration, protocol development and verification of designs.
  • Documenting and Managing Change - Justifies changes, quality and regulatory information, and manufacturing readiness information.
  • Completes change documentation to include technical rationale and formal verification test results.
  • Advances Engineering Expertise - Maintains current technical skills and functional area expertise.
  • Anticipates and/or Develops/Applies Risk Mitigation - Reviews engineering technical risks and take appropriate action. Provides input into risk management documentation including FMEA and risk analyses.
  • Collaborates across functional areas - Exchanges information with product team members, scientists, engineers, and other systems development personnel.
  • Ensures quality through design Techniques and Design Alternatives - Participates in Engineering Design Reviews utilizing Engineering Procedures and Engineering Tools and incorporates recommendations.
  • Performs Investigations - Participates in investigations to determine root cause for low complexity issues.
  • Arrives at timely conclusions.
  • Maintains adherence to the Quality System -Implements and maintains the effectiveness of the quality system. Follows functional area policies and procedures.
  • Utilizes appropriate experimental, statistical, and engineering tools.
  • Obtains Customer Feedback for new and/or Improve Products - Gathers inputs from internal sources and from members of the project\xe2\x80\x99s cross functional team to help meet product needs.
  • Strategic Orientation -Ensures activities are focused on team priorities.
  • Works with cross functional team in collaborative environment.
  • Compiles and evaluates design and test data, prepares technical specifications, and determines appropriate limits and variables for product, process, or materials specifications.
  • Coordinates with technical support personnel to conduct prototype or experimental runs of products or processes.
  • Applies the results of reviews of literature, patents, and current practices relevant to the solution of current problems.
  • May assign work to designers, technical writers, and engineering technicians.
  • Coordinate activities with other areas May provide input on potential candidates to be hired into the team, Interface with product team members, PCB designers, manufacturing or design engineer, R&D, marketing, regulatory (internal) and site engineering.
  • Analyzes Data and Procedures /Recommends Solutions: Analyzes data, procedures, or design requirements taking into account financial and business considerations, draws conclusions and recommends options for complex or multiple process and product problems., Creates/ Modifies Designs for Intermediate Problems: Designs or modifies and specifies more complex components, subsystems, or software programs, writes detailed design specifications.
  • Integrates Project Activities: Estimates and coordinates resources needed (material, time, budget, and people) to accomplish a task makes estimates based on program schedule and requirements. Translates Regulatory Requirements into Validation Process: Creates efficient protocols for validation of complex system functions and defines validation process.
  • Exchanges Information: Exchanges information with appropriate frequency and within a time frame to maximize its utility and promote cross functional collaboration, verifies that information is understood by the recipient.
  • Adapts Information to Customer Needs: Delivers communications tailored to the needs of the receiver (Managers, peers, customer) Makes Presentations: Defines purpose and objectives, organizes ideas, prepares A-V aids, keeps to time frame and presents intelligibly.
  • Actively Listens: Listen actively to acquire information and understand the others viewpoint.
  • Give Constructive Feedback: Give appropriate, helpful information specific to the issue, uses examples, ties feedback to specific business issues.
  • Resolves Conflicts: Faces conflicts and takes initiative to resolve them constructively so all parties can be productive, knows when to involve others.
  • Actively Participates in Team Meetings: Actively participates in design review to meet team goals by offering pro and con suggestions, works toward consensus.
  • Shares Resources, Knowledge, and Accountability: Shares resources and knowledge, assures the team takes accountability, draws on strengths of each team member.
  • Serves in Multiple Team Roles: Serves as leader, contributor, facilitator, consultant, technical expert, arbitrator, evaluator according to the needs of the team and task.
  • Initiates Decisions: Makes timely and effective decisions, considers alternatives, uses sound judgment, achieves closure on work Confronts Issues: Confronts issues in a constructive manner and at an appropriate organizational level, perseveres in the face of adversity.
  • Motivates Others: Keeps morale high by encouraging others, giving positive feedback, and setting a good example, makes and keeps commitments.
  • Receive/Give Performance Feedback: Asks for and gives feedback on the strengths and development needs of self/ others.
  • Identify Future Development Needs: Translates changes in business goals and objectives into the skills, knowledge and experience needed for future work Plans for and Achieves Development: Prepares a plan that sets appropriate development goals, establishes timelines to fulfill development needs, balances the time needed for accomplishing current work and achieving development goals.
  • Recognizes risk: Recognizes risks relative to procedures and regulatory requirements and take appropriate action.
  • Quantifies Risks: Identifies and quantifies technical risks and their consequences relative to the overall success of the project, recommends appropriate actions, Aligns Strategy to Customer Needs: Modifies operational practices and technical recommendations to accommodate internal and external customer needs.
  • Recommends Responses to Technical Trends: Synthesizes technical and customer information to analyze and recommend responses to market and competitive trends, Develop or Refines Processes or Components: Develops new or refines existing processes or components for systems.
Required Qualifications
  • Bachelor\'s Degree in an engineering or closely related discipline with two to four years of related work experience or sufficient transferable experience to demonstrate functional equivalence to a degree.
  • Minimum 2 years\xe2\x80\x99 experience.
Preferred Qualifications
  • Knowledge of regulations and standards affecting IVDs and biologics is desired.
  • 0 \xe2\x80\x93 1 year of experience
  • Applies engineering technical knowledge for specified engineering discipline.
  • Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

Abbott

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Job Detail

  • Job Id
    JD4317749
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Abbott Park, IL, United States
  • Education
    Not mentioned