Software Compliance Engineer

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. The Opportunity This position works out of our Alameda, CA location in the Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. The Software Compliance Engineer participates as a lead member of the Software Quality Assurance (SWQA) team for Abbott Diabetes Care products that ensures digital applications and firmware produced by ADC is developed, validated, and maintained in compliance with regulatory, corporate and divisional requirements. This person will monitor design controls that govern the development, verification, validation, use, and maintenance of medical device software. The Software Compliance Engineer will also coordinate activities with other engineering disciplines, departments, and contractors. What You’ll Work On Reviews change plans for impact to project deliverables, and provides guidance to the document owners regarding changes to software requirements specifications, and software design descriptions for Abbott’s suite of diabetes management software (cloud and mobile). Reviews test plans and test reports to ensure all software changes are verified, and software system is adequately regressed across all environments in accordance with design controls and Quality System Requirements. Monitors defect management process and provides guidance to Systems Engineering and V&V teams to ensure software bugs are logged, investigated, tested and dispositioned. Active participant in an Agile software development process, including daily Scrum and other recurring Sprint ceremonies. Completes software quality tasks in accordance with current Quality System Requirements. Works independently with objectives given by SWQA Manager. Can plan and coordinate own work according to higher-level project schedules. Assists in the development and maintenance of departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines (ISO 13485, ISO 14971), including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, verification, validation, and maintenance of medical device software. Software Quality lead in various phases of the development lifecycle, as well as initiation of corrective and/or preventative action as it applies to software development activities. Maintains schedule and drive to meet project schedule as aligned with project(s) goals. Will also estimate, plan, schedule and review own and others’ work products and be accountable for the quality of those reviews and delivery on schedule. Considered SWQA compliance SME in support of external/internal audits. Required Qualifications Bachelor’s degree, or equivalent experience, in a scientific, technical, or engineering discipline. 2 to 5 years’ experience in Software Quality Assurance and/or Software Testing experience. Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. Has knowledge of Design Control requirements. Must have 1 - 3 years project experience in software testing practices, methodologies including Agile and techniques, preferably in testing medical devices and mobile applications. Preferred Qualifications Must have excellent oral and written communication skills. ASQ Certifications a plus. Medical Device experience strongly preferred. Cybersecurity, medical mobile applications or cloud computing experience preferred. The base pay for this position is $90,000.00 – $180,000.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY

Operations Quality

DIVISION

ADC Diabetes Care

LOCATION

United States > Alameda : 2901 Harbor Bay Parkway

ADDITIONAL LOCATIONS

United States > Milpitas : 1820 McCarthy Blvd

WORK SHIFT

Standard

TRAVEL

Yes, 10 % of the Time

MEDICAL SURVEILLANCE

No

SIGNIFICANT WORK ACTIVITIES

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. Abbott is an Equal Opportunity Employer, committed to employee diversity. EEO is the Law link - English: EEO is the Law link - Espanol: #J-18808-Ljbffr Dormont Manufacturing Co