#22325 - Systems 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 are looking for a Systems Engineer to join our growing team.

Location: US/CAN/MX/ARG (remote) 

3 must haves:
1. Hands on experience shipping regulated medical software (SaMD / digital health)
- 7+ years working on regulated software based products 
- Exposure to medical devices, digital health, clinical platforms, or diagnostic software
- Participation in regulatory submissions, audits, or inspection readiness activities (even if not the sole owner)

2. Strong systems engineering fundamentals across requirements, architecture, and validation
- Proven requirements ownership and traceability mindset
- Experience contributing to system or software architecture decisions
- Hands on involvement in verification and validation activities
- Deep strength in one or two areas, with working knowledge of the rest
- Backgrounds split between Systems, Software, QA, or Reliability roles

3.  Comfort working under design controls in modern development environments
- Experience operating in design controlled environments
- Familiarity with risk based thinking applied to software
- Ability to balance Agile or hybrid development with compliance expectations 
- FDA, ISO, IEC, or equivalent regulated frameworks
- Medical, aerospace, automotive, or other safety critical domains (as adjacent experience)

Role overview
The Systems Engineer applies a systems-thinking approach to the design, development, verification, and lifecycle support of regulated digital health software. Working across the full product lifecycle — from concept and requirements elicitation through architecture, development, verification and validation, launch, and post-market surveillance — the Systems Engineer ensures that products meet their intended use safely, effectively, and in compliance with applicable regulatory expectations and international standards.

The role serves as the technical owner of requirements, architecture, risk, and verification strategy for software medical devices and regulated digital health applications. The Systems Engineer translates customer, clinical, and regulatory needs into technical specifications; partners with software engineering, quality, regulatory affairs, human factors, clinical, and commercial teams throughout the lifecycle; and maintains end-to-end traceability from user need through design and testing to released product.

The Systems Engineer performs this role on a shared, medical-grade software platform used across multiple customer programs. Deep fluency with the company's platform — its microservices, cloud services, and APIs — is a core expectation of the role, and the Systems Engineer is expected to anchor requirements, design, and test strategy in what the platform actually does while partnering with engineering to evolve it where customer needs require.

Key responsibilities

• Requirements engineering:
  Elicit, analyze, decompose, document, and manage system and software requirements — functional, non-functional, clinical, regulatory, cybersecurity, and data-privacy — through the full product lifecycle.
  Translate customer intent, clinical workflows, and business objectives into technical requirements that are essential, critical, and testable; identify and manage requirement ambiguity and conflict.
  Establish and maintain bidirectional traceability from user needs through system and software requirements to architecture, design, and verification artifacts.
  Manage requirements changes under formal change control, including impact analysis and regression planning.
• Systems architecture and design:
  Define and document the end-to-end system and software architecture, including data flows, interfaces, API contracts, integration points, and deployment topology.
  Make and document architectural trade-off decisions across safety, security, performance, usability, maintainability, and cost.
  Collaborate with software engineering, platform engineering, and data engineering to align product-level architecture with the underlying platform architecture.
• Risk management and human factors:
  Lead risk management activities in accordance with ISO 14971, including risk management planning, hazard analysis, software FMEA, fault-tree analysis, risk-benefit analysis, and residual-risk evaluation.
  Partner with usability and human factors engineering to apply IEC 62366-1 across the lifecycle, including use-specification development, use-related risk analysis, formative and summative evaluations, and the Human Factors Engineering file.
  Ensure risk controls are implemented, verified, and traced back to identified hazards and hazardous situations.
• Verification, validation, and quality engineering:
  Define and execute the verification and validation strategy for software medical devices and regulated digital health software, including software verification per IEC 62304 and system validation against intended use.
  Author and review test plans, protocols, and reports; ensure acceptance criteria are unambiguous, objective, and traceable to requirements.
  Apply FDA Computer Software Assurance (CSA) principles and a risk-based approach to assurance activities proportional to the software safety class and intended use.
  Support design reviews, design history file (DHF) development, and technical file preparation.
• Cybersecurity and data privacy:
  Integrate cybersecurity into the systems engineering lifecycle per FDA cybersecurity guidance, AAMI TIR57, and IEC 81001-5-1, including threat modeling, secure-by-design requirements, vulnerability management, and software bill of materials (SBOM).
  Apply data-privacy-by-design principles aligned with HIPAA, GDPR, and applicable regional requirements.
  Partner with platform security and IT security functions to maintain a defensible security posture across the product lifecycle.
• Regulatory strategy support:
  Partner with Regulatory Affairs to support regulatory submissions and interactions, including FDA pre-submissions, 510(k), De Novo, PMA, and EU MDR Technical Documentation as applicable.
  Contribute to SaMD classification analyses and align product design evidence with FDA SaMD and IMDRF frameworks, including Predetermined Change Control Plans (PCCPs) for AI/ML-enabled SaMD where relevant.
  Support responses to regulatory and notified-body questions, audits, and inspections.
• Lifecycle management and post-market surveillance:
  Support post-market surveillance activities, including complaint handling, adverse event evaluation, CAPA, change control, and periodic safety updates.
  Feed field experience and monitoring data back into risk files, requirements, and design artifacts to maintain a defensible state of control.
  Maintain the currency of technical documentation as products and the underlying platform evolve.
• Cross-functional leadership and stakeholder engagement:
  Serve as a credible technical voice across Product Management, Software Engineering, Quality, Regulatory, Patient Experience, Clinical/Medical, and customer-facing teams.
  Engage directly with customer technical, quality, and regulatory counterparts; technical design reviews, audits, and inspections.
  Mentor and develop adjacent engineering and program roles toward independence on requirements definition, technical decision-making, and regulated-software discipline.
• Platform fluency:
  Build and maintain deep fluency across the company's platform’s microservices, cloud services, and API interfaces so that requirements, architecture, and test cases are anchored in real platform behavior.
  Partner with platform engineering to evolve the platform where customer requirements demand it, and to avoid introducing product-level design that conflicts with platform direction.
• Pragmatic process stewardship:
  Right-size process to the software safety class and regulatory classification: know which steps cannot be skipped, and know which controls are optional theater.
  Partner with Quality to keep the QMS fit-for-purpose — protecting compliance without over-burdening software delivery.
  Escalate early and constructively when capacity, quality, or risk is at stake; exercise sound judgment about when to invoke a call or conversation rather than an asynchronous message.

Required qualifications

Education
-Bachelor’s degree in Biomedical Engineering, Computer Science, Electrical Engineering, Software Engineering, Systems Engineering, or a related technical discipline. Advanced degree preferred.

Experience
-7+ years of systems engineering experience in regulated medical software, with a material portion focused on SaMD, cloud-based clinical applications, or regulated digital health platforms.
-Demonstrated experience shipping regulated software products through regulatory clearance, approval, or CE marking.
-Experience working in an Agile or hybrid software development environment operating under formal design controls.
-Experience leading or partnering with nearshore and/or offshore software development teams.

Technical skills:
-Strong requirements engineering discipline, including elicitation, decomposition, prioritization, and end-to-end traceability.
-Systems and software architecture experience, including cloud-native, microservice, and API-driven architectures.
-Verification and validation planning and execution, including authorship of test strategies, protocols, and reports for regulated software.
-Applied experience with software risk analysis techniques — software FMEA, fault-tree analysis, hazard analysis, and risk-benefit analysis — per ISO 14971.
-Working knowledge of cybersecurity-by-design practices for regulated software, including threat modeling, SBOM, and vulnerability management.
-Familiarity with human factors and usability engineering per IEC 62366-1.

Regulatory and standards knowledge:
-FDA Quality System Regulation (21 CFR Part 820), with applied expertise in design controls (21 CFR 820.30) as applied to software.
-IEC 62304 — medical device software lifecycle processes.
-ISO 14971 — application of risk management to medical devices.
-IEC 62366-1 — usability engineering for medical devices.
-ISO 13485 — QMS for medical devices.
-FDA SaMD guidance and the IMDRF SaMD framework.
-FDA cybersecurity guidance, AAMI TIR57, and/or IEC 81001-5-1.
-Health data privacy frameworks including HIPAA and GDPR.

Preferred qualifications
-Master’s degree in an engineering or regulatory discipline.
-INCOSE SEP or CSEP certification.
-Experience with AI/ML-enabled SaMD, including Predetermined Change Control Plans (PCCPs) and Good Machine Learning Practice (GMLP).
-Experience with health interoperability standards such as HL7 FHIR, where applicable to the product portfolio.
-Exposure to EU MDR and EU IVDR technical documentation and Notified Body interactions.
-Experience supporting FDA pre-submissions, 510(k), De Novo, or PMA submissions.
-Experience with post-market surveillance, complaint handling, and CAPA systems.
Familiarity with FDA Computer Software Assurance (CSA) guidance as applied to production and QMS software.

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 $100,000 - $110,000.
• 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!