Sr. Engineering Manager Software Design Quality

Medtronic - Los Angeles, CA

Full-time - Senior

Los Angeles, CA

Miscellaneous Manufacturing

About the position

Medtronic leads the health care industry to provide solutions that benefit the daily lives of people across the globe. Our organization contributes directly to this mission through our rich software system, which includes Embedded products, Mobile and Cloud-based applications combined with scaled infrastructure and advanced analytics. As a Sr. Software Design Quality Manager, you will lead the Software Design Quality team focused on Medtronic's Embedded device portfolio. You will be responsible for managing and guiding the design quality engineers in both the pre-market design and sustaining space. Your role will involve driving the development of safe, reliable, and compliant products and systems while working closely with cross-functional teams to build a highly technical and competitive design quality engineering team. The ideal candidate will be a critical thinker and problem solver, with strong execution skills and a self-driven attitude. You will need to possess strong leadership skills and a hands-on management approach. Excellent verbal and written communication skills are essential, as you will be required to maintain strong relationships with various stakeholders. In this role, you will plan, direct, and implement all quality aspects of the company's design and development of new and sustaining medical device products or software systems, with a detailed focus on software reliability, risk management, and patient safety. You will provide oversight and training in the application of work processes to ensure successful adoption by development teams, leading to positive, measurable results from development programs. You will also manage activities to assure programs are appropriately resourced and ensure continuous improvement in technical capability, processes, and compliance. Your expertise will be crucial in interpreting policies and regulations to ensure compliance and in providing process analyses oversight to enforce requirements and meet regulations.

Responsibilities

• Plans, directs, and implements all quality aspects of the company's design and development of new and sustaining medical device products or software systems, focusing on software reliability, risk management, and patient safety.
• Provides oversight and training in the application of work processes to ensure successful adoption by development teams and positive, measurable results from development programs.
• Works closely with cross-functional teams and quality peers to ensure project planning is complete end-to-end for both pre-market and post-market activities.
• Manages activities to assure programs are appropriately resourced and ensures continuous improvement in technical capability, process, and compliance.
• Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Communicates program status using clear metrics and specific action plans, engaging organizational acumen appropriate for a senior-level audience.
• Facilitates uniform standards worldwide and enables best practice sharing by fostering the achievement of the company's mission globally.
• Manages feasibility studies of the design to determine if capable of functioning as intended.
• Selects, develops, and evaluates personnel to ensure the efficient operation of the function.

Requirements

• Bachelor's degree required in Engineering, Science or technical field with 7+ years of experience in the embedded software medical device space and 5 years of technical leadership or managerial experience.
• OR Advanced Degree in Engineering, Science or technical field with 5+ years of experience in the embedded software medical device 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 with strong knowledge of product development in regulated industries (such as medical device, healthcare, aerospace, or transportation industries).
• Working knowledge of IEC 62304, 21 CFR 820.30 and ISO 14971.
• Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDDEU MDR.
• Ability to author technical reports, business correspondence and standard operating procedures.
• Experience in using 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

• Short-term incentive plan
• Wide range of benefits and resources
• Competitive compensation plans