Abbott

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:

The Opportunity:

The opportunity is located in Milpitas, California. We are looking for an individual who has the ability to work within and influence a cross-functional, matrix R&D organization. Also, have the ability to develop automated testing framework and automated test scripts. Should be able to follow established policies and procedures, create new processes and procedures, and comply with regulatory requirements. Strong ability to recognize problems and recommend/implement solutions.

What you will be doing:

• 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 and conduct software, hardware, and system-related verification and validation strategy for the R&D organization and ensure the execution of the strategy
• Design and conduct system-level integration verification test of complex data collecting and processing tool ecosystem; Collect, organize, analyze, and document test results. 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.

Qualifications:

• Bachelor’s Degree (BS) in an engineering discipline, preferred Bio-medical engineering.
• Minimum of four (4) years of experience in verification, design assurance or quality assurance role supporting medical devices, preferably with FDA Class II/III experience

Preferred Qualifications:

• 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.
• Excellent analytical and problem-solving skills
• Motivated self-starter with the ability to work independently and collaboratively
• Must be comfortable and able to work well in a fast-paced environment. This requires the ability to be flexible and able to manage 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

The base pay for this position is

$86,700.00 – $173,300.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Product Development

DIVISION:

ADC Diabetes Care

LOCATION:

United States > Milpitas : 1820 McCarthy Blvd

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 5 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf