Qualitest Group is a global engineering company whose services and expertise are powered by artificial intelligence. Qualitest Group helps businesses reach their goals and prioriti
Systems Engineer
Location
United States + 3 moreAll locations: United States | Canada | Argentina | Mexico
Posted
30 days ago
Salary
$100K - $110K / year
Seniority
Mid Level
No structured requirement data.
Job Description
Systems Engineer
Qualitest Group
Role Description We are looking for a Systems Engineer to join our growing team. Location: US/CAN/MX/ARG (remote) Qualifications - 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 - 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 - Experience operating in design controlled environments - Familiarity with risk based thinking applied to software - Ability to balance Agile or hybrid development with compliance expectations - Experience with FDA, ISO, IEC, or equivalent regulated frameworks - Experience in medical, aerospace, automotive, or other safety critical domains Requirements - Elicit, analyze, decompose, document, and manage system and software requirements through the full product lifecycle. - Translate customer intent, clinical workflows, and business objectives into technical requirements. - Establish and maintain bidirectional traceability from user needs through system and software requirements. - Manage requirements changes under formal change control. - Define and document the end-to-end system and software architecture. - Lead risk management activities in accordance with ISO 14971. - Define and execute the verification and validation strategy for software medical devices. - Integrate cybersecurity into the systems engineering lifecycle. - Partner with Regulatory Affairs to support regulatory submissions. - Support post-market surveillance activities. - Serve as a credible technical voice across various teams. - Build and maintain deep fluency across the company's platform. - Right-size process to the software safety class and regulatory classification. Benefits - Support for diversity and inclusion in the workplace. - Local and global opportunities for internal rotation and international mobility. - Clear view of career progression with the company. - Flexible and casual culture with employee events and amenities. - 401k plan with company matching contributions. - Competitive healthcare benefits with HSA matching. - Learning & Development platform with 50,000+ courses. - Corporate Wellness Program with gym membership reimbursement. - Bonuses via Client Referral and Employee Referral Programs. - Recognition through the Qudos platform. - Access to Employee Perks for discounts on various services. - Competitive pay, with a salary range of $100,000 - $110,000.
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