Software Quality Engineer I
About The Position
The Software Quality Engineer I position, supporting Released Product Engineering (RPE) for the Acute Care & Monitoring (ACM) Operating Unit, focuses on development, improvement, and innovation through technical excellence and cross-functional collaboration. This role is ideal for individuals who pride themselves on problem-solving skills, meticulous attention to detail, and a passion for quality. The successful candidate will provide quality engineering support in the design and development of medical device products across the ACM portfolio, facilitating the application of Design Controls, Risk Management, and Change Control processes in the evaluation and release of product changes. Medtronic is a global healthcare technology leader committed to alleviating pain, restoring health, and extending life, with a team of over 95,000 passionate people dedicated to engineering extraordinary solutions and advancing healthcare, society, and equity.
Requirements
- Requires a Baccalaureate degree and 0 years relevant experience.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
- Possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Responsibilities
- Critically review new and modified product and software changes to determine their impact to existing or new product requirements and their effect on, patient safety, standards compliance, and reliability.
- Ensure that design changes to existing products are conducted in compliance with Medtronic’s QMS, ISO13485, EU-MDR and the FDA Quality System Regulations.
- Lead cross-functional teams to develop product risk management files (risk management plan, risk assessments, dFMEA, and risk management report).
- Assist in the creation of verification and validation test plans, protocols and reports.
- Review testing and analysis for standards and product requirements compliance.
- 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.
Benefits
- Competitive Salary
- Flexible Benefits Package
- Health insurance
- Dental insurance
- Vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- 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
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
- Paid sick time (for temporary employees, as required under applicable state law)
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
