Software Quality Engineer II

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**Job Title: Software Quality Engineer II**
**Req Number: 20004BQ**
**Location: Louisville, CO**
Work with more senior software quality engineers to support all software related activities during New Product Development lifecycle, such as the design, development, test, and market release of Product software used in real time Navigation System in our Neuroscience team.
In this exciting role as a **Software Quality Engineer II** you will:
Witness cutting edge surgical navigation and robotic technologies designed to alleviate pain, restore health and extend life.
Work closely with the product development teams consisting of software, system, test and other senior software quality engineers in the development of new software releases for our product lines. Activities may include providing quality oversight and recommendations to improve the quality of the product design during the following activities:
Requirements definition
Design and Use/Mis-Use Failure Mode and Effects Analysis
Verification testing and reporting
Software defect disposition
Design History File audits
Execute work using an Agile Scrum framework to manage development activities.
Engage in a collaborative, diversified and energetic team environment focused on delivering high quality products to our patients and users.
**Neuroscience**
The Neuroscience Portfolio group develops life-restoring therapies and healthcare solutions that span the neurological care continuum including 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/ Responsibilities include the following but not limited to:**
Supports product quality and reliability ensuring the implementation of cutting-edge technology for medical devices is safe, effective, and compliant with regulations, standards, and industry practices. 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.
Collaborate with test engineering on verification and validation strategies, review and approve test protocols and reports.
Support internal audits and external audits by regulatory agencies, as the need arises.
**Must Have: Minimum Requirements (Must be evident on your resume)**
Bachelors Degree in Engineering, Science or technical field with
2 years of work experience in Engineering and/or Quality
OR
Advanced Degree in Engineering, Science or technical field with 0 years of work experience in Engineering and/or Quality
**Preferred**
Experience in the medical device industry
Experience with FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standards
Navigation systems experience preferred
Excellent oral and written communication skills
Ability to work effectively in a team 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
ASQ certification as a Software Quality Engineer or Software Quality Auditor
**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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.
**Physical Job Requirements**
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. (ADA-United States of America)
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.
Categories
Healthcare
Engineering
Information Technology
Financial Services
Posted:
2022-03-01
Expires:
2022-03-31
Medtronic

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