Senior Design Quality Engineer

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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

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’ll 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 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 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 Plano, TX site in our Neuromodulation division.  

Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.  

As the Senior Design Quality Engineer you will assure new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. 

  

What You’ll Work On 

• Serve on product development teams promoting and assuring quality in product development projects. 
• Execute and support on-time completion of Design Control Deliverables for projects related to Design Change, Clinical and New Product Development.  
• Work with cross functional team to execute and/or support various areas of Design Control processes, such as Design Input requirements, Design Outputs, Design Verification and Design Validation.
• Support the assessment/establishment of objective, measurable, discrete, and verifiable customer and product requirements. 
• Support product development equipment qualification activities, inspection method development and validation activities. 
• Accountable for Applicable Standards Document & checklists, Labeling Verification planning & execution, Essential Output reports, and General Safety and Performance Requirements (GSPR). 
• Ensure Design History File content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps. 
• Lead Risk Management activities for development projects and supplier change requests, including generation and maintenance of risk assessments, risk management plan/report, hazard analysis and failure mode effects & criticality analysis (FMECA).

• Maintain Risk Management Deliverables to ensure continued acceptability of products based on post market feedback.  

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. 
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. 
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. 
• Comply with U.S. Food and Drug Ad