Abbott Sr. Software Development Quality Engineer - ATE in Plano, Texas
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
We are seeking an experienced, high caliber Software Development Quality Engineer assure new or modified Automated Test Equipment (ATE) development conform to quality standards and establishes compliance with the quality system. You will be responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. This is a hands-on role where you will apply self-directed and diversified engineering and quality principles to our devices and systems. The quality engineer will support Neuro Modulation ATE development. They will help maintain the quality system, ensure that all processes are efficient and followed during the development lifecycle, champion process improvement, gain domain knowledge over the product, help troubleshoot issues, protect the business during audits, and seek to improve the quality of products.
Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
Impact this role will have on Abbott:
Plans, performs and documents development quality related activities, including but not limited to quality test, procedures for new and modified products and components, engineering test, and reliability tests. Collaborates with R&D and Project Managers to establish test design and acceptance criteria. acceptance criteria.
Designs and conducts Process Validation Plans related to products being qualified and new equipment. Writes clear, concise, and complete reports.
Design and perform acceptance testing on ATE systems and Non-Product Software
Uses laboratory test equipment and instrumentation to obtain test data from the devices and analyze the data.
Audits software verification. Verifies test equipment/software repeatability.
Support quality activities ensuring automated test verification and validation planning, execution, and deliverables comply with quality system regulations
Responsible for running compliance and/or performance tests as needed to ensure delivery of a test system, and conducting cross-functional root-cause analysis investigation and issue resolution activities
Support and ensure the establishment of objective, measurable, discrete, and verifiable test design requirements
Build a strong collaborative relationship with the development organization to ensure on-time completion of required deliverables for test design, verification, validation, implementation and installation.
Support DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
Support manufacturing process development & qualification for new product commercialization and product changes
Your experience(s), education and knowledge will further expand Abbott’s marketplace success:
Bachelor degree, or advance degree in Computer Science, Computer Engineering or Electrical Engineering
Minimum 5 years’ experience on ATE development and / or ATE validation in medical device and/or other highly regulated industry
Working knowledge of 21 CFR part 820, IEC 62304, IEC 82304-1, ISO 14971, and ISO 13485
Experience with software development, using languages such as C, C++, C#, Java and LabVIEW
Experience with ATE and Non- Product Software validation.
Experience with system and/or software configuration management.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Ability to work in a highly matrixed and geographically diverse business environment
Meticulous and methodical with high attention to detail
Solid communication and interpersonal skills
Ability to travel approximately 10%
Ability to maintain regular and predictable attendance
Your preferred qualifications and education:
Advanced degree (e.g. MS) or equivalent practical experience
Experience with Class III medical devices
Strong foundation in computer science, computer engineering, or electrical engineering with strong competencies in ATE and Non-Product Software design and validation
Capable of deep-dives into code
Strong verbal and written communications with ability to effectively strategize and communicate at multiple levels in the organization
Multitasks, prioritizes and meets deadlines in timely manner
Strong organizational and follow-up skills
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com