#20229 - Systems Reliability Engineer

Are you interested in working with the world’s leading AI-powered Quality Engineering company? Ready to advance your career, team up with global thought leaders across industries, and make a difference every day? Join us at Qualitest!

We’re seeking a Systems Reliability Engineer to join our growing team in the Atlanta, Georgia, USA.

Role: Systems Reliability Engineer
Location: Atlanta, Georgia, USA.

Key Responsibilities:

• Own the system reliability strategy, ensuring reliability is embedded early and throughout the product development lifecycle.
• Define and manage reliability requirements and architecture, translating user needs, clinical use conditions, and risk assessments into measurable reliability goals.
• Develop reliability plans and models (e.g., RBDs, fault trees, FMEAs, life expectancy models) to guide design and verification activities.
• Lead Design of Experiments (DOE) and statistical methods to identify critical design parameters affecting reliability and to optimize system performance margins.
• Establish system reliability verification and validation strategy, covering environmental stress, accelerated life, fault tolerance, and reliability growth testing.
• Partner with system architects, design engineers, quality, and regulatory teams to ensure reliability is integral to design decisions.
• Contribute to risk management activities in compliance with ISO 14971 — linking reliability goals to safety and performance risk controls.
• Develop reliability test strategies that provide statistical confidence in meeting reliability targets (e.g., MTBF, failure rate, reliability growth curves).
• Support regulatory submissions (e.g., to U.S. Food and Drug Administration or EU MDR) with technical reliability evidence and rationale.
• Drive root cause analysis and reliability growth initiatives based on test and field data.
• Lead post-market reliability monitoring strategies and link learnings into future design iterations.

Required Qualifications:

• Bachelor’s or Master’s degree in Systems Engineering, Electrical/Mechanical Engineering, Biomedical Engineering, or related field.
• 7+ years of experience in system reliability engineering for regulated Class II/III medical devices.
• Demonstrated expertise in reliability planning and modeling, DOE, accelerated life testing, and reliability statistics.
• Strong working knowledge of design controls per 21 CFR Part 820 and EU MDR.
• Proven ability to influence architecture and design decisions to meet reliability goals.
• Experience developing technical documentation for regulatory submissions and audits.
• Deep familiarity with risk management processes (per ISO 14971) and quality systems (per ISO 13485).
• Strong systems thinking, analytical, and leadership skills.

Preferred Qualifications:

• Experience with connected and software-enabled medical systems.
• Familiarity with relevant standards such as IEC 60601, IEC 62304, and IEC 62366.
• Hands-on experience with reliability modeling tools (Weibull, FTA/FMEA platforms, reliability block diagrams).
• Certification such as CRE (Certified Reliability Engineer) or equivalent.
• Experience influencing design through data-driven reliability insights and DOE findings.

Benefits
Why QualiTest?

• Be a part of a company who strives to support for diversity and inclusion in the workplace – we are one, we are many at Qualitest. Celebrate culture, share knowledge with engineers from around the globe, and inspire each other through our differences. We have more than 40% women and around 120 different nationalities.
• Local and global opportunities – we offer you internal rotation and international mobility opportunities to grow your career.
• Clear view of your career and progression with the company – Qualitest is growing massively (since 2021 – tripled our employees base – we now have more than 8,000 engineers) and giving you the opportunity to grow with us.
• Work hard and play harder with our flexible and casual culture. Take a break from work and join an employee event, or enjoy the amenities and games provided from one of our Employees Centers.Save your earnings and prepare for your future by enrolling in our 401k plan where Qualitest will match your contributions accelerating your savings plan.
• Take care of health with enrollment into one of our competitive healthcare benefits. Qualitest will match towards your HSA if you choose to participate.
• Never stop experimenting and learning with QCraft – our Learning & Development platform: 50,000+ courses, 300+ virtual labs, mentorship and leadership programs, professional tribes, sponsored certifications, and much more.
• Stay active and get rewarded with our Corporate Wellness Program. We pay your Gym membership and giving you opportunities to Earn additional vacation times for attendance the gym!
• Earn bonuses via our Client Referral and Employee Referral Program’s. Refer and earn – tap your network for net-worth.
• We recognize our employees work via our Qudos platform - You can earn bonuses and spot awards by celebrating your and your peers’ achievements.
• Planning a vacation? Looking for car insurance? Get access to Qualitest Employee Perks for discounts on anything from travel to electronics. With so many offerings the savings are endless!
• A Competitive pay, the salary range for the role is $110,000 - $120,000.
• Intrigued to find more about us?
• Visit our website at https://www.qualitestgroup.com/
• If you like what you have read, send us your resume and let’s start talking!