Senior Software Quality Engineer at Medtronic in Lafayette, Colorado

Job Description:

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life
Join Medtronic's Endoscopy operating unit as a Senior Software Quality Engineer, where you'll play a vital role in ensuring the integrity and security of our software systems. In this position, you will focus on maintaining our Information Security Management System in alignment with ISO 27001 standards. Your expertise will help us uphold the highest levels of quality and compliance, ultimately contributing to our mission of improving patient outcomes through innovative medical technology. If you are passionate about software quality and security, we invite you to be a part of our dynamic team.

Locations: Lafayette, CO (hybrid work model - 3 days a week in office)

Responsibilities may include the following and other duties may be assigned.

• Maintains compliance to standards for quality management systems, information security systems, and risk management.


• Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.


• Assists enterprise teams with responses to customers requesting evidence of compliance to information security standards.


• Collaborates with enterprise teams and manages security of information assets as applicable to product portfolio.


• Helps develop security compliance metrics.


• Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives.


• Reviews software systems design, change specifications, and plans against contractual and/or process requirements.


• Provides or directs verification and validation of software system requirements, traceability, and testability.


• Support audits and assesses the risk profile for information security risks.


• Qualifies design and process changes and ensures that corrective measures meet acceptable standards, and that documentation is compliant with requirements.


• Support software product development, design control, and design transfer processes, as well as responsibility for quality deliverables during product development


• Defines appropriate measures to ensure product quality.

Must Have: Minimum Requirements

• Bachelor's degree in Engineering, Science, or a technical field with 4 years of engineering experience

• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Nice to Have

• Degree in software engineering with 4+ years of software quality engineering experience


• Working knowledge / experience with ISO 27001


• Working knowledge with medical device design controls


• Working knowledge in software development (IEC 62304)


• Working knowledge in risk management (ISO 14971)


• Experience in product risk assessment, requirements management and tracing, defect tracking, configuration management techniques, and how they are applied in the software development lifecycle

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 Responsibilities 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):98,400 - 147,600

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 90,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here .

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.

At Medtronic, most positions are posted on our career site for 3-7 days.