Software Quality Engineer I

Medtronic • Lafayette, CO

5d

About The Position

We anticipate the application window for this opening will close on - 20 Mar 2026 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 Software Quality Engineer I position, supporting Released Product Engineering [RPE] for the Acute Care & Monitoring [ACM] Operating Unit, is one of development, improvement, and innovation, through technical excellence and cross functional collaboration. If you pride yourself on your problem-solving skills, meticulous attention to detail and passion for quality this may be the role for you. You will be tasked to provide quality engineering support in design and development of medical device products across the Acute Care and Monitoring [ACM] portfolio of products. Facilitating the application of Design Controls, Risk Management and Change Control processes in the evaluation and release of product changes. As our Software Design Quality engineer for RPE, your Key Accountabilities will involve: 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. 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 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. TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills. DIFFERENTIATING FACTORS Autonomy: Entry-level individual contributor on a project or work team. Works with close supervision. Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities. Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems. Communication and Influence: Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information. Leadership and Talent Management: N / A – job at this level is focused on self-development.

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.

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

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• 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
• 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 (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level