Senior Manager, Software Design Control (Medical Devices)

The Opportunity

Increase your chances of an interview by reading the following overview of this role before making an application.

This position works out of the Pleasanton, CA, or Burlington, MA location in the Heart Failure Division, Quality Department.

Our Heart Failure business includes implantable devices and peripheral systems with software / firmware, Cloud-based Patient Care Networks, and mobile applications to help people who suffer from Heart Failure.

In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor, and manage heart failure, allowing people to restore their health and get on with their lives.

As a Senior Manager focusing on Software Quality and associated design controls at Heart Failure, you will have the opportunity to develop and improve technology platforms that improve the lives of those suffering from Heart Failure.

Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company.

We are team-oriented, fast-paced, and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

What You’ll Work On

• Provide guidance and strategic input to teams for development of medical product software (embedded, Cloud Patient Care Networks, and mobile), non-medical software, and non-product software.
• Partner with the Product Security Group to continually improve cybersecurity and associated quality system processes.
• Lead improvement of the Heart Failure Division’s software design controls to meet the needs of an evolving technology and regulatory landscape around embedded and mobile software platforms.
• Hire and retain a diverse, highly qualified staff and provide ongoing performance feedback. Set goals which align to business and department plans and manage the execution of goals through coaching and mentoring.
• Assess resource needs to assure that an appropriate level of quality support is provided when needed with the competencies needed.
• Develop direct reports by securing appropriate training, assigning progressively challenging tasks, and providing regular written and verbal performance feedback.
• Monitor work operations and provide direction and guidance to experienced exempt employees or skilled nonexempt staff to achieve unit or project goals.
• Provide quality assurance oversight for software development deliverables (e.g., requirements, software V&V, etc).
• 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, 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 efficiency improvements.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.

Ensure 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, Computer Science, Life Science, or closely related discipline.
• 9+ years experience in a Quality, Regulatory, or product development role in a regulated industry.
• 3+ years experience leading a team of technical / quality professionals.
• Knowledge of FDA regulations and guidance, ISO 13485, Software Standards (e.g., IEC 62304), EU Medical Device Regulations, and MDSAP.

Preferred Qualifications

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

The base pay for this position is $144,100.00 $288,300.00. In specific locations, the pay range may vary from the range posted.

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