Highly Experienced Medical Device Design Quality Engineer

1 week ago


Atlanta, Georgia, United States Abbott Laboratories Full time
About Abbott

Abbott is a global leader in the healthcare industry, committed to helping people live more fulfilling lives at all stages. Our diverse portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and pharmaceuticals.

We have a dedicated team of 114,000 colleagues serving people in over 160 countries worldwide.

Career Development Opportunities

At Abbott, you can grow and develop your career in an international company that values innovation and collaboration. You will have access to:

  • Career development opportunities with a global leader in the healthcare industry
  • Excellent retirement savings plan with high employer contribution
  • Tuition reimbursement program for further education and professional growth
  • Freedom 2 Save student debt program
  • FreeU education benefit – an affordable and convenient path to getting a bachelor's degree

Our company has been recognized as a great place to work in dozens of countries around the world and named one of the most admired companies globally by Fortune.

The Opportunity

In our Heart Failure business, we are developing innovative solutions to diagnose, monitor, and manage heart failure, allowing people to regain their health and pursue their passions.

We are seeking an experienced Sr. Design Quality Engineer to join our team and contribute to the development of medical devices that meet the highest standards of quality and safety.

Job Description

This role involves working closely with cross-functional teams to ensure that our medical devices are developed in accordance with Abbott's design control requirements and state-of-the-art product standards.

You will be responsible for:

  • Leading and/or supporting on-time completion of Design Control deliverables for new product development projects and design change projects
  • Establishing objective, measurable, discrete, and verifiable customer and product requirements
  • Supporting design verification and validation planning & execution, including any cross-functional investigation and resolution activities
  • Ensuring DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Leading risk management activities from product concept through commercialization
  • Supporting test method development and lead test method validation activities
  • Supporting the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Supporting biocompatibility and sterilization qualifications
  • Supporting audits and quality system improvement activities
Requirements

To succeed in this role, you will need:

  • Bachelor's degree in Engineering or Technical Field
  • Minimum of 5 years of experience in medical device Quality Engineering, Research & Development, or Process / Manufacturing Engineering with experience supporting product development
  • Experience in test method development and validation
  • Experience in preparing risk assessments, FMEA, and other risk documents
Preferred Qualifications

Advanced degree in Biomedical Engineering or related discipline

Experience in active implantable medical devices

Experience in electro-mechanical medical devices and associated regulations / standards

Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA)

Working knowledge of statistics and its application to verification and validation

Experience with software verification and validation activities, including test case protocols and reports and software development plans

Salary

The base pay for this position is $72,700 - $145,300. In specific locations, the pay range may vary from the posted range.



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