FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in software quality assurance for medical devices, ensuring compliance with FDA regulations and international standards. Proficient in risk analysis, software development, and collaboration with cross-functional teams to enhance product reliability and security.
Highest-signal resume keywords
Software Quality AssuranceRisk AnalysisPython ProgrammingCardiac/Electrophysiology ExperienceRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Software DevelopmentRisk AnalysisTraceability DocumentationTestability DocumentationCompliance DocumentationSoftware Quality Metrics TrackingDesign History File ReviewDefect AssessmentHealth Risk AssessmentCAPA Support
Soft Skills
Excellent Communication Skills
Tools & Technologies
PythonQtDockerLinux
Industry Keywords
FDA CFRMDRIEC 62304ISO 13485Medical Device IndustryCybersecuritySoftware LifecycleElectrophysiology Procedures
Tech Stack
Tools & technologiesCyber SecurityDockerLinuxPythonQt
About the role
Key responsibilities & impact- Support software quality efforts for Cardiac Ablation Solutions products and ensure compliance with FDA CFR, MDR, IEC 62304, and ISO 13485
- Serve as a member of the extended quality team for Affera software releases used for electrophysiology procedures
- Collaborate with quality team members to complete assigned functional work within program deadlines
- Participate in software risk analysis activities
- Support post-market activities including defect assessments, issue assessments, health risk assessments, and CAPAs
- Review and approve Design History File documents covering requirements, design, development, integration, testing, verification, validation, and tooling
- Develop and review documentation for traceability, testability, and compliance
- Build expertise in assigned products and projects through engineering lab work and product training
- Track software quality metrics and support continuous monitoring and improvement
- Recommend design or test methods to improve product reliability and security
- Propose design or testing changes to improve software and process reliability
- Contribute to quality engineering program strategies for product reliability objectives
- Review and support product security testing strategies
- Attend a live EP case at least once per year when available and participate in virtual live case learning
- Collaborate with R&D, medical safety, regulatory affairs, and clinical teams
Requirements
What you’ll need- Bachelor's degree and a minimum of 0 years of relevant experience
- Proven ability to write new software code
- Ability to quickly and effectively read, interpret, and understand existing software code
- For Baccalaureate degrees earned outside of the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
- Applicants must be authorized to work in the country of employment without sponsorship
- Unrestricted U.S. work authorization at the time of hire and for the duration of employment
- Excellent written and oral communication skills
- Medical device or other regulated industry experience and/or experience working with a software development team
- Experience performing formal risk analysis
- Experience using or working with Python, Qt, Docker, and Linux
- Knowledge of cybersecurity and the software lifecycle within regulated environments
- Experience with cardiac/electrophysiology medical specialties
- Advanced degree in a relevant field
Benefits
Comp & perks- Competitive salary and flexible Benefits Package
- Short-term incentive called the Medtronic Incentive Plan (MIP)
- 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)
- Temporary employees are eligible for paid sick time, as required under applicable state law
- Employee Stock Purchase Plan for temporary employees