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Manager, Software Design Controls

3 months ago


Plano, United States Abbott Full time

The Opportunity

This position works out of our Plano, Texas location in the Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders.

The Manager, Software Design Controls is responsible for leading a team of quality and development engineers to solve problems and make sound design recommendations, in accordance with corporate, divisional and applicable regulatory requirements. Provides leadership and mentoring to engineers with the capability to perform hands-on participant as necessary.

What You’ll Work On

Provide guidance and strategic input to product development teams for product software (embedded and mobile, medical and non-medical) and non-product software. Contributes to the development of internal Design Controls processes to meet the needs of an evolving technology and regulatory landscape around embedded and mobile software platforms. Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment. Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed. Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews. Monitors work operations and provides direction and guidance to experienced exempt employees or skilled nonexempt staff to achieve unit or project goals. Ensure that appropriate risk management processes are in place, focused on software related risks including design, cybersecurity, and data integrity risks. Lead, oversee or participate in multiple portions of the Quality System, including but not limited to Management Review, Internal Audit, Audit Readiness, NC/CAPA, Document Control, Training, Product Release, and others as needed. Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and proactive improvements. 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. Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.

Required Qualifications

Bachelor’s degree, preferably in Engineering, Technical Field, Life Science, or closely related discipline. 8+ years’ experience in a Quality, Regulatory, or product development role in a regulated industry. 3+ years’ experience leading a team of technical/quality professionals.

Preferred Qualifications

Prior experience in a software-focused company or company with software as a medical device (SAMD).

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