Experienced Software Manager who can lead and manage Medical Device Software Verification team; capable of managing testing of Medical Device Software including embedded software and GUI, and related activities in regulated environment. The individual is responsible for managing Software test team, authoring the test plans and strategies to ensure the software meets the user and product design requirements, and releasing the verified and validated software. This individual leads the Software verification and validation effort and defines the strategy for manual and automated tests. He/she isolates, reproduces and tracks defects and verifies fixes. The software manager will assist in the continuous improvement and modification of the Software. He/she leads assessment and planning of test efforts required for new functions / features under development.
- Directly manage Software Test team, and overall Software test activities for new and existing product lines
- Work collaboratively with and provide technical leadership to internal and external resources in order to design and develop the test artifacts
- Build, mentor and manage Software test engineering team
- Oversee in-house and outsourced Software testing activities and related inputs
- Manage test team activities, assign tasks according to project goals and evaluate results
- Track individual and team progress against goals and objectives, and evaluate performance of team members
- Develop testing plans, requirements and protocols based on evaluated changes and the assessed risk
- Work with engineering disciplines to ensure that requirements specifications are written in a testable manner
- Work across broader organization to share and implement embedded software testing "best practices"
- Develop test plans, test procedures and lead verification and validation efforts
- Lead and coordinate cross-functional teams in the effort to release Software on the market
- Provide inputs for projects planning including effort estimation, scheduling, tracking, and priority-setting
- Design and development of changes to Windows-based embedded and desktop applications
- Design and development of automation testing tools in regulated environment
- Defend Software verification in regulatory inspections and/or internal audit
- Keep abreast of development and test techniques and tools
- Develop the test environment and set up regression, integration, and system tests
- Define Software requirements, design, code and validate software tools
- Define and implement configuration management tools and methodologies
- Lead software release activities for product and tool software into manufacturing and the field
- Contribute to Design Transfer effort; interface with manufacturing and field representatives
· BS in Software Engineering, Computer Science, Mathematics or STEM
· Experience managing Software testing teams and activities
· 10 years of experience in Medical Device software domain
· 7 years of experience of software testing of medical devices
· 3+ years of experience in a high level programming language such as C, C++ and/or C#
· Experience in implementing and executing processes based on IEC 62304, ISO 13485 and ISO 14971
· Previous Software testing leadership role in Medical Device or GxP industry
· Experience designing and developing automated tests for embedded and Windows based software
· Hands-on: SW verification planning, test strategy development, design of test protocols and executing software integration and system testing
- Demonstrated technical leadership of medical device Software integration / verification projects
- Experience with scripting languages (Python, Perl, batch) for software build and automated testing
- A strong team player with the demonstrated abilities and willingness to wear “multiple hats” and perform a wide range of tasks within a dynamic environment
- Ability to communicate effectively with peers, management, and international customers to solve problems and broker information
- Strong analytical and problem solving skills a must
- Self-motivated quick learner, able to participate both as a team member and an individual contributor
· Ability to multi-task and complete assignments on time
· Proficient in the use of MS Office, SW Development and SW Testing tools
· Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR)
· AI learning models knowledge and / or implementation skills
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.