Principal Software Design Quality Engineer
Principal Software Design Quality Engineer
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$ 123200 - 184800
1 Vacancy
Job Description
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
Prin. Software Design Quality Engineer
Medtronic ENT (Ear Nose and Throat) is an operating unit within Medtronics Neuroscience Portfolio. The unit focuses on providing innovative solutions for ENT conditions including surgical and therapeutic products designed to improve patient outcomes in ear nose and throat health.
We are currently offering an excellent opportunity to join the ENT Quality team as a Prin. Software Quality Engineer. This position is based onsite in Jacksonville FL.
In this role you will serve as an individual contributor with responsibilities in our technical functions to advance existing technology or introduce new technologies and therapies. You will be tasked with formulating delivering and managing assigned projects collaborating with other stakeholders to achieve desired results. You may mentor colleagues or direct the work of lower-level professionals. Your primary focus will be on delivering research and development systems or initiatives related to new technologies or therapiesfrom design to implementationwhile adhering to policies utilizing specialized knowledge and skills and continuously improving products and processes. This position involves providing design quality engineering support for the software design and development of medical devices stand-alone software of non-products non-devices and components including firmware. Additionally you will facilitate the application of design controls in product development and released product management.
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 software quality. Develops and maintains quality and reliability metrics.
Works on software reliability controls including reliability prediction stress and performance testing for software.
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.
Lead and conduct risk management activities including system risk analysis (ISO14971) and software risk management documentation including system level risk management reviews Failure Mode and Effects Analysis product risk assessments and assessing specific product issues for impact to patient and/or user safety.
Participate and review cybersecurity documents such as SBOM STRIDE analysis and Penetration testing.
Follow all Quality System Practices as defined by Medtronic Navigations practices policies and Standard Operating Procedures (SOPs) to ensure that FDA ISO and European Medical Device quality standards and regulations are met where applicable.
Provides or directs verification and validation of software system requirements traceability and testability.
Must Have: Minimum Requirements
Bachelors degree in Computer Engineering Software Engineering Computer Science Electrical Engineering or a technical field.
Minimum of 7 years of technical experience
Or advanced degree with 5 years of technical experience.
To be considered for this role please ensure the minimum requirements are evident on your resume.
Nice to Have
Experience with medical device design controls embedded devices hardware and software interactions
Experience in software development standards (IEC 62304 IEC 81001 ISO 14971 ISO 13485) preferred
Experience in test automation during new product development
Experience in one or more of the following areas: C/C C# Linux/Unix Python automated testing frameworks
Demonstrated knowledgeable in scripting languages (e.g. PowerShell Python Bash) and relevant numerical libraries
Understanding and appreciation of SDLC process and tools (e.g. Azure DevOps JIRA Bitbucket Stash Confluence JAMA Git CMake.)
Experience in effectively applying software quality tools for static code analysis code coverage code quality etc.
Experience in product risk assessment requirements management and tracing defect tracking configuration management techniques and how they are applied in the software development lifecycle
Proven leadership experience organizing and directing engineering teams
Flexible and adaptable comfortable working in a dynamic environment
Cybersecurity experience is desirable
DIFFERENTIATING FACTORS
Autonomy:Recognized expert managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments with limited oversight from manager. Coaches reviews and delegates work to lower level specialists.
Organizational Impact:Contributes to defining the direction for new products processes standards or operational plans based on business strategy with a significant impact on work group results. May manage large projects or processes that span outside of immediate job area. Innovation and Complexity:Problems and issues faced are difficult moderately complex and undefined and require detailed information gathering analysis and investigation. Develops solutions to moderately complex problems and/or makes moderate to significant improvements of processes systems or products independently to enhance performance of job area. Implements solutions to problems.
Communication and Influence:Represents organization as a primary contact for specific projects and initiatives; communicates May negotiate with others to reach understanding or agreement and influence decision-making.
Leadership and Talent Management:Typically provides guidance coaching and training to other employees within job area. Typically manages major / moderately complex projects involving delegation of work and review of work products at times acting as a team leader.
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.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).
Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
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 95000 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.
If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Required Experience:
Staff IC
Employment Type
Full-Time
