WHAT YOU’LL DO
- Provide guidance and training to the site engineers for Non-Product Software development and validation, Data Integrity, Cybersecurity, 21 CFR part 11 requirements and ensure compliance for the same.
- Work with R&D and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes.
- Participate in reviews for Non-product System and Software requirements with ability to interpret and review system design (hardware, firmware, software) and provide useful feedback.
- Create and execute or direct software validation protocols traceable to system/software requirements. Execute and support on-time completion of Quality Engineering deliverables: test plans (manual and automated), test scripts (manual and automated), test reports
- Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems.
- Assist in the completion and maintenance of risk analysis, focused on software related risks including cybersecurity and data integrity risks.
- Design and implement various product and process improvement methodologies (i.e, Six Sigma and Lean Manufacturing).
- Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving issues.
- Support internal (corporate and divisional) and external quality audit
- 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.
EDUCATION AND EXPERIENCE YOU’LL BRING
- Bachelors Degree Engineering or Technical Field(Electrical/Computer Engineering preferred) Or an equivalent combination of education and work experience
- Minimum 2 years
- Software Quality Engineering experience
- Prior medical device experience preferred.
- Knowledge of Cybersecurity and Data Integrity (ALCOA+) principles preferred.
- Experience in Bluetooth enabled systems, firmware or embedded software testing and verification/validation preferred.
- Programming experience in C/C++/C#, Scripting Language such as Python.
- Experience with software configuration, and issue-tracking tools such as GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla.
- Knowledge of FDA 21 CFR part 820, 21 CFR part 11, GMP, IEEE 1012, IEC 62304 and ISO 13485. Advanced computer skills, including statistical/data analysis and report writing. Advanced Information Technology and data mining skills. ASQ CSQE certification desired.
- 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.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities
The base pay for this position is $65,900.00 – $131,900.00. In specific locations, the pay range may vary from the range posted.Explore Location
