Sr. Software Design Quality Assurance Embedded

at  Medtronic

We anticipate the application window for this opening will close on - 21 Feb 2025
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.

MUST HAVE: MINIMUM REQUIREMENTS

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
Bachelor’s Degree in Engineering, Science or Technical Field with 4+ years of experience in Engineering, Software Development and/or Quality
OR
Advanced Degree Engineering, Science or Technical Field with 2+ years of experience in Engineering, Software Development and/or Quality.

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.

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)

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance , Health Savings Account , Healthcare Flexible Spending Account , Life insurance, Long-term disability leave , Dependent daycare spending account , Tuition assistance/reimbursement , and Simple 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 match , Short-term disability , Paid time off , Paid holidays , Employee Stock Purchase Plan , Employee Assistance Program , Non-qualified Retirement Plan Supplement (subject to IRS earning minimums) , and Capital 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.

• Lead as a quality core/extended team member responsible for driving quality into the embedded software solutions implemented in embedded C.
• Lead the collaborative quality strategy for projects in alignment with business goals for cross-functional teams including R&D/Regulatory/Marketing/Operations.
• Lead quality focused design and development of software within the software development lifecycle (Agile/waterfall/ SAFe/DevOps) by defining the requirements, design, verification and validation plan and strategies while maintaining traceability.
• Participate in design reviews for the system as well as review and approve design input/design output artifacts including requirements, design documents, code review reports, test results. verification and validation reports and defects.
• Lead and conduct risk management activities including system risk analysis (ISO14971) and software FMEA’s.
• Lead and drive CAPA (Corrective and Preventative Action) projects.
• Participate in both internal and external regulatory audits and inspections.
• Lead quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures (such as ISO13485/IEC62304/HIPAA/FDA/Security Standards/Data Privacy)
• Define appropriate metrics to measure product quality and drive reliability.
• 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