Design Assurance Engineer

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. Youâll 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 bachelorâs 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 is an onsite opportunity in the Abbott Diabetes Care Division. We are helping people with Diabetes lead healthier, happier lives.   As a global leader in diabetes care, Abbott is constantly working to deliver the highest quality products and unwavering support to our customers.  Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, so weâre committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels.

As a Design Assurance Engineer II, you are responsible for responsible for developing and maintaining test methods, design validation and design verification activities for the division (e.g. commercialized products, new product development, manufacturing, and/or system compliance). 

This is an onsite daily opportunity in Milpitas, Ca.

What Youâll Do

• Provide guidance for establishing good product and system design requirements, design specifications, detailed designs, verification and validation activities, and planning documentation (e.g. test plans)
• Develop and implement design assurance engineering concepts, principles, and best practices
• Develop software, hardware, and system-related verification and validation strategy for the R&D organization and ensure the execution of the strategy.
• Participate in development activities, including design reviews, requirements analysis and tracing, defect tracking, and software configuration management.
• Support the risk management activities for software and systems in compliance with ISO 14971 and software risk requirements in IEC 62304.
• Debug Issues and provide appropriate evidence for development team.
• Specify and execute validation testing for test tools utilized in the product verification.
• Ensure that product development projects and changes to existing products are conducted in compliance with the FDA, ISO Quality System Regulations, and internal Abbott SOPs.
• Develop Test plans, and test cases based upon the product and component level requirements.
• Create test reports to summarize test results and appropriately track and resolve deviations and defects per Abbott SOPs.

Experience Youâll Bring 

Required 

• Bachelors Degree in  Engineering or Technical Field or an equivalent combination of education and work experience
• Masters Degree/Advanced degree preferred
• Minimum 2+ years of  technical experience.
• Previous Quality experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, and ISO 13485.
• Solid communication and interpersonal skills.
• Demonstrated and impactful project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality system-related issues in a timely and effective manner.
• Advanced computer skills, including gap analysis and report writing skills.
• Prior medical device experience preferred, Six Sigma certification or Lean Manufacturing experience preferred.
• ASQ CQE, CQA certification preferred .
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.

Preferred

• Minimum of 2-5+ years of experience in verification, design assurance or quality assurance role supporting medical devices, preferably with FDA Class II/III experience
• In-depth working knowledge of US FDA Quality System Requirements, ISO 13485, ISO 14971, and IEC 62304.
• Experience with supporting notified body and regulatory inspections and audits
• Experience with electromechanical and embedded systems consisting of custom hardware, software, and software of unknown provenance (SOUP).
• Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.).
• Experience with developing test strategy for integration of system components.
• Working knowledge of Agile Software Development methodologies and associated development tools (SCRUM, Jira, Jama) is highly desirable.
• Familiarity with shell scripting and python
• Experience with test methods and standards for the design, verification, and validation of medical device products with emphasis around software development/testing.
• Knowledgeable about Quality Assurance methodologies related to regression testing, ad hoc testing, functional testing and verification of calculations, user interface testing, and integration testing.
• Skilled in test plan development and root cause failure analysis.
• Strong verbal (including presentation) and written communication skills, especially technical report writing.

Additionally, the ideal candidate will possess the following:

• Ability to work within and influence a cross-functional, matrix R&D organization
• Ability to develop automated testing framework and automated test scripts.
• Excellent analytical and problem-solving skills
• Motivated self-starter with the ability to work independently and collaboratively
• Ability to follow established policies and procedures, create new processes and procedures, and comply with regulatory requirements.
• Ability to recognize problems and recommend/implement solutions.
• Must be comfortable and able to work well in a fast-paced environment. This requires the candidate to be flexible and able to juggle multiple projects at a time.
• Must be hands-on and results-oriented
• Must be a team player, excellent communicator, and comfortable in an entrepreneurial environment.
• Must be positive, energetic, and a strong advocate for product quality.

Apply Now

* 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:  www.abbottbenefits.com

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 www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

The base pay for this position is $65,900.00 â $131,900.00. In specific locations, the pay range may vary from the range posted.