SW Design Quality Manager - Digital Products

$136,000 - $204,000/Yr

MIN Medtronic Minimed Inc. - Los Angeles, CA

Full-time - Mid Level

Los Angeles, CA

About the position

As a Software Design Quality Manager at Medtronic, you will lead the Software Design Quality team focused on the Digital portfolio, including Mobile Apps and Cloud solutions. Your role will involve managing design quality engineers to ensure the development of safe, reliable, and compliant products. You will collaborate closely with cross-functional teams to drive quality assurance processes and foster a culture of continuous improvement in technical capabilities and compliance.

Responsibilities

• Plan, direct, and implement all quality aspects of the design and development of new and sustaining medical device products or software systems.
• Provide oversight and training in the application of work processes to ensure successful adoption by development teams.
• Work closely with cross-functional teams to ensure complete project planning for both pre-market and post-market activities.
• Manage activities to assure programs are appropriately resourced and ensure continuous improvement in technical capability, process, and compliance.
• Provide oversight for the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with policies.
• Interpret policies, regulatory and governmental regulations to assure compliance.
• Provide process analyses oversight to enforce requirements and meet regulations.
• Maintain and modify quality assurance programs and policies regularly.
• Communicate program status using clear metrics and specific action plans for a senior-level audience.
• Facilitate uniform standards worldwide and enable best practice sharing.

Requirements

• Bachelor's degree in Engineering, Science, or a technical field with 5+ years of experience in the Digital and Cloud space and 5 years of technical leadership or managerial experience.
• OR an Advanced Degree in Engineering, Science, or a technical field with 3+ years of experience in the Digital and Cloud space and 5 years of technical leadership or managerial experience.

Nice-to-haves

• Direct experience in software or systems engineering in a design engineering role.
• Extensive experience in complex product development projects in regulated industries such as medical device, healthcare, aerospace, or transportation.
• Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1, and MDD/EU MDR.
• Ability to author technical reports, business correspondence, and standard operating procedures.
• Experience in applying metrics to measure and improve processes and product quality during product development.
• Proven track record of success in leading cross-functional efforts in work process improvement.
• Experience in influencing, educating, and fostering others in adopting work practices.

Benefits

• Competitive Salary
• Flexible Benefits Package
• Short-term incentive called the Medtronic Incentive Plan (MIP)