Careers that Change Lives

Your dedication is important to our customers and, most importantly, to their patients.

Medtronic is currently seeking a Sr Software Quality Engineer.

This position has the responsibility and authority to define and execute work with minimal guidance to strengthen the design, development, test, and market release of software used in both surgical navigation applications and other medical devices. Partner in the creation and streamlining of processes and tools used to create, test, and maintain medical device software applications. Advance aspects of the Quality Management System to align with applicable standards, regulations and guidance documents.

Do meaningful work, make a difference, and improve lives - starting with your own.

The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

A Day in the Life

• Actively participate in product development cycle by reviewing software project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements.
• Engage cross-functionally to implement improvements to the software development life cycle, including the establishment of risk management as an integral part of the quality management system as an overall framework for the application of appropriate software engineering methods and techniques.
• Create and revise Standard Operating Procedures (SOPs) and other documentation to support the Quality System in regards to software and system design.
• Identify and implement software process metrics for the software product development life cycle. Develop, analyze and monitor metrics pertaining to software defects uncovered during development, testing and post-release.
• Recommend and lead corrective and preventive actions to improve software product quality. Ensure documentation and findings are completed on time and in a timely manner in accordance with FDA and European Regulatory agency standards and procedures.

General responsibilities may include:

• 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.

Must Have - Minimum Requirements

EDUCATION REQUIRED:

• B.S./B.A. in Engineering or similar related field

YEARS OF EXPERIENCE

• 4+ years of previous experience in an engineering position with B.S./B.A.
• 2+ years of previous experience in an engineering position with M.S./M.A.
• 0+ years of previous experience in an engineering position with Ph.D

SPECIALIZED KNOWLEDGE REQUIRED

• Experience in a Regulated environment
• Skilled in product risk assessment, requirements management and tracing, defect tracking, configuration management techniques, and how they are applied in the software development lifecycle.
• Working knowledge in one or more of the following areas: C/C++, Linux/Unix, Python, automated testing frameworks

Nice to Have

• Working knowledge of FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, ISO 62366, and ISO 62304 standards.
• Formal training in Lean and Six Sigma methods combined with project deployment experience at the green belt or greater level is highly desirable.

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 required responsibilities 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.

EEO

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here:http://www.uscis.gov/e-verify/employees