Validation Engineer
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Job Location:
Saint Paul, MN - USA
Monthly Salary:
$ 61300 - 122700
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
Validation Engineer
Working at Abbott
At Abbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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 and FreeU education benefit - an affordable and convenient path to getting a bachelors degree.
- A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity working mothers female executives and scientists.
The Opportunity
This position works out of our St. Paul MN location in our Structural Heart Abbotts Structural Heart (SH) business our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.
As the Validation Engineer youll be responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software utilized throughout business unit.
What Youll Work On
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.
Required Qualifications
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 Qualifications
- Prior medical device experience preferred.
- Experience working in a broader enterprise/cross-division business unit model preferred.
- Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:
- Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.
- Connect with us at on Facebook at and on Twitter @AbbottNews.
The base pay for this position is
$61300.00 $122700.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
SH Structural Heart
LOCATION:
United States > Minnesota > St. Paul : 1225 Old Highway 8 NW
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes 5 % 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.
EEO is the Law link - English: EEO is the Law link - Espanol: Experience:
IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
