Abbott · 6 hours ago
Validation Engineer
United States - Minnesota - St. Paul
Full-time
Onsite
Entry, Mid Level
$61K/yr - $123K/yr
2+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. As a Validation Engineer, you will execute and maintain software quality engineering methodologies while providing quality engineering support for software utilized throughout the business unit.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
Responsibilities
Develop and conduct training of company personnel for the divisional software development and validation program
Work with software owners in the completion of system/software requirements and other verification and validation processes
Facilitate software validation protocols traceable to system/software requirements
Implement solutions for controlling code and facilitate the use of Code Control and Software Event/Defect Tracking software systems
Assist in the completion and maintenance of risk analysis, focused on software-related risks
Design and implement various process improvement methodologies (i.e, Six Sigma and Lean Manufacturing)
Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving issues
Assesses software for Part 11 applicability and other software validation deliverables
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Qualification
Required
Bachelors Degree in Engineering or Technical Field or an equivalent combination of education and work experience
Minimum 2 years Software Quality Engineering or Quality Engineering experience
Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485
Advanced computer skills, including statistical/data analysis and report writing
Advanced Information Technology and data mining skills
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
Ability to travel, including internationally, of up to 5%
Preferred
Prior medical device experience preferred
Experience working in a broader enterprise/cross-division business unit model preferred
Benefits
Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with a high employer contribution
Tuition reimbursement
The Freedom 2 Save student debt program
FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
10001+ employees
H1B Sponsorship
Abbott has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
Recent News
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