Principal Software Quality Engineer - Infrastructure/Post‑Market

Medtronic; Mounds View (MN); On-site; USD 124,800 - 187,200; Full time

Job summary

Medtronic is seeking a Principal Software Quality Engineer - Infrastructure/Post-Market to drive the safety and reliability of electrophysiology systems software. This role involves leading software evaluations, conducting health risk analyses, and ensuring compliance with regulatory standards.

Applicants should possess a Bachelor's degree with a minimum of 7 years of experience, or a Master's degree with 5 years of experience in related fields. Strong knowledge of medical device quality systems and regulations is essential.

Qualifications

• Minimum of 7 years of relevant experience with Bachelor's degree.
• 5+ years of experience with Master’s degree or 3 years with PhD.

Responsibilities

• Lead post-market software issue evaluations.
• Drive health risk analyses based on device performance.
• Ensure software documentation is audit-ready.

Skills

Medical device quality systems knowledge

Analytical skills

Communication skills

Risk assessment experience

Program management

Education

Bachelor's degree in relevant field

Master’s degree or PhD in relevant field

Job description

We anticipate the application window for this opening will close on - 15 Jun 2026.

Principal Software Quality Engineer - Infrastructure/Post-Market

Join Medtronic as a Principal Software Quality Engineer - Infrastructure/Post-Market, and take a leading role in ensuring the safety, reliability, and compliance integrity of Affera cardiac electrophysiology systems software used in live clinical environments worldwide. In this high‑impact position, you will drive complex issue evaluations and health risk analyses based on real‑world device performance.

Primary Responsibilities

• Build and maintain deep system‑level understanding of Affera software performance in clinical use through regular engagement in live case observations.
• Lead and execute post‑market software issue evaluations, including complaint analysis, risk file assessments, and impact determination.
• Serve as a principal author of Health Risk Assessments (HRAs) for software anomalies and corrections, ensuring clear linkage between observed software behavior, risk files, and system‑level impacts.
• Act as a quality and compliance authority for selected software‑related CAPAs, guiding root cause analysis, mitigation strategy development, and verification of effectiveness.
• Author, review, and approve post‑market quality system documentation, including issue evaluations, CAPA records, risk file updates, and field action support materials.
• Drive software field corrective action intake and follow‑on actions for the CAS OU.
• Ensure post‑market documentation is audit‑ready, technically defensible, and aligned with FDA, EU MDR, and global regulatory expectations.
• Partner closely with cross‑functional teams to track metrics that drive timely and compliant resolution of software issues.
• Provide program management/coordination support, technical mentorship, and strategic guidance to other engineers supporting complaint handling, investigations, and post‑market surveillance activities.
• Influence enterprise‑level post‑market software quality processes as needed.
• Represent post‑market software quality during inspections, audits, and internal reviews, providing preparation support, clear technical and regulatory rationales, and assistance.

Required Qualifications

• Bachelor's degree and a minimum of 7 years of relevant experience
• OR Master’s degree with a minimum of 5 years of relevant experience
• OR PhD with 3 years relevant experience

Preferred Qualifications

• Bachelor’s degree in software engineering, computer engineering, electrical engineering, biomedical engineering, or a related technical field.
• 7+ years of experience in software quality, reliability engineering, post‑market surveillance, software engineering, or regulated medical device development
• Strong working knowledge of medical device quality systems and regulations, including FDA CFR, MDR, ISO 13485, and IEC 62304.
• Ability to read, interpret, and evaluate software behavior, logs, and technical data to support investigations.
• Excellent analytical and written/oral communication skills.
• Capability to secure hospital credentialing for clinical site visits.
• Experience supporting post‑market surveillance or activities for complex medical device software on capital equipment.
• Experience leading post‑market software issue evaluations, risk assessments, and CAPA activities.
• Experience working with risk analysis documentation such as FMEAs and FTAs.
• Experience working with cardiac electrophysiology medical devices.
• Skilled in program management and work/metric tracking across complex systems and multiple products.
• Advanced degree in a relevant technical or quality discipline.
• Quality or regulatory certifications (ASQ, Six Sigma, or similar).

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.

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.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal‑level roles and above, where specialized expertise aligns with long‑term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Benefits & Compensation

Salary ranges for U.S. (excluding Puerto Rico) locations (USD): $124,800.00 - $187,200.00. This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP). 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.

Equal Employment Opportunity

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 find here 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.