Sr. Director of Software Design Quality Engineering

DexCom • San Diego, CA

11d • Onsite

About The Position

The Sr. Director of Software Design Quality Engineering is responsible for all aspects of Software Quality Engineering, including managing and mentoring Quality Engineering staff globally. You’ll partner closely and collaboratively to drive the development, test and release of product software and firmware as well as software infrastructure, while ensuring the development process is compliant with all US and International development standards.

Requirements

• Deep understanding of software requirements and best practices toward: IEC 62304 compliance
• Agile development in medical devices
• Automated testing methodologies
• FDA General Principles for Software Validation
• FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
• FDA Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
• FDA Guidance for Post-market Management of Cybersecurity in Medical Devices
• Expertise or strong working knowledge of Food and Drug Administration 21 CFR PART 820, Quality System Regulation
• Expertise or strong working knowledge of Food and Drug Administration 21 CFR PART 11, Electronic Records; Electronic Signatures.
• Typically requires a Bachelors degree in a technical discipline with 17+ years of industry experience.
• 13+ years of years of successful leadership experience in relevant industry.

Responsibilities

• Manages the Software Quality Assurance Team globally.
• Defines priorities and delegates responsibilities.
• Leverage customer and consumer feedback to drive continuous improvement initiatives aligned with departmental and corporate strategic goals.
• Promote cross-functional understanding and adherence to quality standards and regulatory requirements.
• Responsible for establishing and reporting on key software development metrics.
• Summarize and report quality findings to executive management during the Quality Management Review, to project/program managers, and the development team as needed.
• Provides coaching and guidance on defining world class project plans, requirements, design, and test cases.
• Work with R&D to ensure development and test processes comply with the latest regulations and identify potential compliance gaps; work with the departments to discuss how to apply best practices to meet regulations.
• With assistance and buy in from departments, update relevant procedures.
• Guide risk management activities to drive collaborative discussions on appropriate mitigation strategies.
• Ensure the team is prepared for regulatory agency audits.
• Provide leadership and expertise in the Design/ Phase Review process to ensure compliance to process.
• Coordinates, manages and tracks the team’s efforts, ensuring milestones are met within defined budgets and schedules.

Benefits

• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Director