Software Quality Engineer II (Independence, OH)
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
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.*This will sit out of our Independence, OH office*
Join Medtronic as a Software Quality Engineer II and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll work alongside a team of engineers and cross-functional partners to drive quality for design, development, and maintenance of operating systems and manufacturing/service tooling software releases for Affera cardiac electrophysiology systems. By blending technical expertise with a passion for quality, compliance, and improving patient outcomes, you'll have the opportunity to impact global healthcare as the usage of Affera grows rapidly worldwide.
Primary Responsibilities
Support software quality and reliability efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO 13485.
Serve as a member of the extended quality team for operating system and service/manufacturing tooling software releases across the Affera portfolio. Collaborate with other quality team members to take accountability for completing assigned functional work within program deadlines.
Review and approve various Design History File documents related to software and security, including requirements, design, development, integration, test protocols, test reports, verification, validation, and tooling. Ensure all documentation meets reliability standards and follows QMS processes.
Develop and review documentation for traceability, testability, and compliance according to standard operating procedures.
Develop expertise in assigned products and projects, including hands-on time in the engineering lab and participation in product training as assigned.
Participate in software and process risk analysis and defect assessments as assigned.
Contribute to tracking software quality metrics for assigned programs, supporting continuous monitoring and improvement of quality outcomes to achieve required levels of product reliability.
Provide software quality support for post-market activities and analysis, including work supporting issue assessments, health risk assessments, and CAPAs.
Recommend design or test methods to achieve appropriate levels of reliability and security. Propose changes to design or testing as necessary to improve software and/or process reliability.
Contribute to reliability engineering program strategies to achieve Medtronic, customer, and regulatory reliability objectives for assigned programs.
Review and support strategies for product security testing as assigned.
As business needs permit, periodically visit manufacturing and servicing facilities to aid in understanding of quality processes related to software loading and tooling.
Regularly participate in virtual electrophysiology patient case learning opportunities.
Collaborate with cross-functional teams, including R&D, regulatory affairs, and clinical teams, to ensure alignment on quality and compliance requirements.
Travel Requirements <15%
Required Qualifications
Bachelor's degree and a minimum of 2 years of relevant experience
OR Master’s degree with a minimum of 0 years of relevant experience
Preferred Qualifications
Ability to demonstrate basic competency in coding, and effectively read, interpret, and understand existing software code.
Excellent written and oral communication skills.
1+ years of industry experience working with a software development team.
Experience creating risk analysis documentation such as FMEAs and FTAs.
Experience using or working with products built on Python, Linux, Docker, Windows, AWS, REST APIs, React, and/or Flutter/Dart.
Knowledge of cybersecurity and the software lifecycle within regulated environments, including design, development, and post-market support.
Advanced degree in a relevant field.
Certification in quality systems or regulatory affairs (e.g., Six Sigma, ASQ, or similar).
#LI-MDT
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 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.
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 95,000+ 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 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.
Average salary estimate
If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.
Medtronic is hiring a remote Reimbursement Coordinator II to manage prior authorizations, verify patient coverage, and support payer interactions to ensure timely access to therapies.
Medtronic is hiring an Area Sales Manager (Enabling Technologies, Neurosurgery) to drive field sales of surgical imaging, navigation and robotics solutions across the Portland, OR territory.
Medtronic is hiring a Sr. Design Quality Manager to lead a global RPE team and drive design control, change control, and risk management to keep the ACM product portfolio state-of-the-art and compliant.
Radiometer (a Danaher company) seeks an on-site Quality Assurance Technician II to manage acceptance documentation, perform inspections, and support quality metrics and continuous improvement for diagnostic products.
Vultr is hiring a Junior Test Automation Engineer to develop and maintain UI and API test automation for its cloud infrastructure platform.
Lead pre-analytical laboratory operations at GRAIL's Durham site as Supervisor, Accessioning, overseeing staff, workflows, and quality to support high-volume, clinically compliant testing.
Senior quality leader responsible for driving global compliance and inspection readiness for cell therapy programs across development and commercial networks at Bristol Myers Squibb.
Medtronic is hiring a Supplier Quality Engineering Manager in North Haven, CT to lead supplier quality programs, manage SCRs, and ensure uninterrupted medical device production.
Experienced UM Pharmacist needed to lead policy translation and clinical validation for an AI-driven prior authorization platform at Innovaccer.
Shield AI seeks an experienced Lead Supplier Quality Specialist to lead supplier quality assurance, audits, and corrective actions for critical aerospace and defense hardware.
Lead development of Nimble's End-of-Line automated test systems to ensure high-throughput manufacturing and production-quality autonomous robots.
Medtronic seeks a hands-on Microbiologist Sterilization Specialist II to drive contamination control, laboratory testing, and cleanroom compliance at its Brooklyn Park manufacturing site.
Jabil is hiring a Director of Microbiology to oversee QC microbiological testing, environmental monitoring, and audit-ready GMP laboratory operations at the Hunt Valley site.
Motorola Solutions' Access Control division is hiring a Hardware Test Engineer in Culver City to design and execute hardware test plans and improve product quality across high-volume access control systems.
Medtronic is hiring a Design Quality Engineer II to provide design-control and risk-management engineering support for ACM medical device products, ensuring compliance with ISO13485, FDA QSR and related standards.
Mission Written in 1960, our Mission dictates that our first and foremost priority is to contribute to human welfare. Over a half-century later, the Mission continues to serve as our ethical framework and inspirational goal for our employees aroun...
66 jobs
🔮
Hi, I'm Risa! Your AI Career Copilot
you, just ask me below!
