Senior Software Design Assurance EngineerAbbott Laboratories company • Burlington, Vermont, United States

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Senior Software Design Assurance Engineer

Abbott Laboratories company

Burlington, Vermont, United States

Burlington, Vermont, United States

Über

Senior Software Design Assurance Engineer Senior Software Design Assurance Engineer is responsible for supporting product development, executing and maintaining software quality engineering methodologies, and providing quality engineering support for software, primarily focusing on software quality while supporting other product development aspects. Responsibilities Provides technical and quality system guides related to establishing software requirements. Provides quality oversight for software verification and validation activities for new products in accordance with design planning procedures, including reviewing and approving software test case protocols and reports, reviewing software development plans, and reviewing other system and software documentation. Leads meetings to prioritize, review, and/or approve action plans for addressing issues captured in problem resolution systems during development. Leads risk evaluation and associated management activities related to software development, including risk assessments (e.g., FMEA), product risk analysis, and mitigation of software issues. Participates in technical and management reviews to ensure design plans, product design, and deliverables related to product software are met. Represents the quality engineering function for the review and approval of designated design outputs. Provides quality oversight for non-product software validation by assessing the need for validation and preparing and/or supporting protocols, reports, and other documentation as required. Might be involved with supporting product cybersecurity assessments in conjunction with a cross‑functional team. Complies with US FDA regulations, other country regulatory requirements, company policies, and procedures. Maintains a strong, collaborative partnership with cross‑functional team members, especially with R&D. Works as an individual contributor and may provide guidance or oversee the work of other QE team members. Develops and conducts training of company personnel for the divisional software development and validation program. Supports audits and leads quality system improvement activities. Additional responsibilities may be assigned as needed. Qualifications Bachelor’s degree in engineering or a technical field. Minimum of 5 years related work experience in Quality or a related field. Knowledge of regulations, standards, and guidance affecting medical software and non‑medical device software development. Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization. Preferred Qualifications Advanced degree. Previous quality engineering experience and demonstrated use of quality tools/methodologies. Experience working in a broader enterprise/cross‑division business unit model. Compensation The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary. Location & Shift United States – Burlington: 23 Fourth Avenue; Pleasanton: 6101 Stoneridge Dr. Work shift: Standard. Travel: Yes, 5 % of the time. EEO Statement Abbott is an Equal Opportunity Employer, committed to employee diversity. 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 - Español: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
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Burlington, Vermont, United States

Sprachkenntnisse

English

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