Sr Software Quality Assurance Engineer
Careers That Change Lives
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 connected health systems, which include Mobile and Web applications combined with scaled infrastructure and advanced analytics. Most recently our team delivered the Guardian Connect™ remote monitoring solution, which help diabetes patients manage their care from anywhere in the world - Just an example of the life-changing services we are chartered to build. Become part of our team and you will be challenged to build these amazing software products, and in the process, make a real difference.
As a Sr Software Quality Engineer, you will serve as a subject matter expert by leading and providing technical design quality support for the new product development and sustaining projects. The individual will act as a subject matter expert and provide guidance to the business in interpreting and executing against Medtronic quality system elements including software/system work products to ensure compliance.
This individual will ensure that all system-level project / program work products (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet Medtronic’s quality, reliability, and compliance requirements.
This individual will ensure Design Quality Assurance-driven initiatives meet objectives in delivering highest quality products, with supporting tools and processes. Diabetes The Diabetes Group is working with the global community to change the way people manage diabetes. Together, we will transform diabetes care by expanding access, integrating care, and improving outcomes so people with diabetes can enjoy greater freedom and better health.
This role will be based out of the Medtronic Diabetes Corporate offices in Northridge, CA (Los Angeles).
A Day in the Life
You will provide PDP and design control expertise for and execution of different BU projects, such as: o Collaborating with project / program teams to ensure work products comply with Medtronic procedures, acceptable qualitative and quantitative criteria, and global standards, regulations, and guidance.
o Generating and driving risk management activities including system risk analysis, DFMEA, PFMEA, SFMEA and requirements compliance matrix (ERM).
o Reviewing of all project / program work products (e.g. plans, requirements, specifications, tests, test results, traceability, design reviews, reports, etc.).
o Participating in code reviews and provide be able to read code.
o Planning and reviewing validation plans for new product development in conjunction with R& D, Process Engineering, Manufacturing, Supplier Quality Assurance, Regulatory Affairs, Marketing and other service groups.
o Assisting Supplier Quality Assurance with supplier audits; interfaces with Purchasing and Supplier Quality Assurance with supplier issues.
o Lead cross-functional change control boards.
• You will be training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements and regulations in support of the deployment of the different BU strategies and products.
• You will drive clarity and consistency in documentation.
• You will be leading CAPA projects and assisting post market analysis.
• Participating in support of external regulatory audits and inspections.
• You will drive Process improvement activities.
• You will work under consultative direction toward predetermined long-range goals and objectives. Assignments are often self-initiated. Determine and pursue courses of action necessary to obtain desired results through consultation and agreement with others rather than by formal review of superior.
Responsibilities may include the following and other duties may be assigned.
- Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.
- Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
- Defines appropriate measures to ensure product quality.
- Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives.
- Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.
- Reviews software systems design, change specifications, and plans against contractual and/or process requirements.
- Reviews include applicable specifications, materials, tools, techniques, and methodologies.
- Provides or directs verification and validation of software system requirements, traceability, and testability.
To be considered for this role, the following minimum requirements must evident on your resume.
Must Have: Minimum Requirements
• Bachelor’s Degree in Engineering or Scientific field and 4+ years of quality and /or engineering experience OR Master’s Degree in Engineering or Scientific field and 2+ years of quality and/or engineering.
• Experience working in a regulated industry (e.g., FDA-regulated)
• Strong working knowledge of quality systems and quality assurance processes and principles, with a focus on software development and/or verification/validation activities.
• Hands on knowledge of design controls and risk management (system risk analysis and FMEA)
• Experience with leading and executing multiple projects in parallel, including large and complex projects.
Nice to Have
• Master’s Degree in Engineering, Quality, Regulatory, or related.
• ASQ Certification in Quality or Reliability.
• Hands on working experience with Mobile Apps (iOS/Android) and/or PC/Web based product software.
• Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD.
• Strong oral/ written communication skills and interpersonal skills.
• Working knowledge of software development for medical devices.
• Ability to author technical reports, business correspondence and standard operating procedures.
• Ability to apply knowledge and work with development and supply vendors to ensure compliance to Medtronic requirements.
• Working experience in a global environment spanning multiple sites and systems; ability to navigate and constructively influence across groups.
• Ability to represent the department in frequent inter-organizational and outside vendor contacts.
• Ability to work effectively within a team in a fast-paced, ever-changing environment.
• Strong verbal and written English communication skills with an ability to effectively communicate at multiple levels in the organization.
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the requiredresponsibilities and skills of this position. The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.