[Hiring] Systems Engineer @Prenuvo
Systems Engineer @Prenuvo
Artificial Intelligence
Salary usd 48 - 58 per..
Remote Location
๐Ÿ‡บ๐Ÿ‡ธ USA Only
Employment Type contract
Posted 1mth ago

[Hiring] Systems Engineer @Prenuvo

1mth ago - Prenuvo is hiring a remote Systems Engineer. ๐Ÿ’ธ Salary: usd 48 - 58 per hour ๐Ÿ“Location: USA

Role Description

We are looking for a Systems Engineer to support the design and development of systems supporting AI-driven diagnostic tools, ensuring they comply with medical device regulations.

  • Support the design, development, and validation of Software as a Medical Device (SaMD) solutions, ensuring compliance with relevant medical device regulations and standards (e.g., ISO 13485, IEC 62304).
  • Collaborate with cross-functional teams, including ML scientists, software developers, clinical experts, regulatory affairs, and quality assurance, to ensure seamless integration of system requirements.
  • Coordinate and document the development of system architecture that ensures scalability, reliability, and compliance with safety and performance standards.
  • Define and document system requirements, functional specifications, risk management strategies, and validation procedures.
  • Conduct risk assessments and manage risk mitigation activities related to system safety and performance.
  • Ensure compliance with FDA and other international medical device regulations and guidelines for SaMD.
  • Oversee verification and validation testing, ensuring traceability from requirements to system performance.
  • Provide technical support during regulatory submissions and audits, collaborating with regulatory teams to ensure successful clearance.
  • Stay current with technological advancements, industry trends, and evolving regulatory requirements for medical devices.
  • Develop design control documentation, including system requirements, design reviews, and traceability matrices.
  • Support post-market surveillance activities, including software updates, patches, and enhancements.

Qualifications

  • Bachelorโ€™s or Masterโ€™s degree in Systems Engineering, Biomedical Engineering, Computer Science, or a related field.
  • Proven experience in system engineering for medical device development, specifically for SaMD.
  • Strong knowledge of regulatory standards and frameworks for medical devices (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
  • Proficiency in system architecture design, risk management, and validation processes for SaMD.
  • Familiarity with software development lifecycle (SDLC) methodologies, Agile processes, and DevOps.
  • Experience with medical image processing, data security, and HIPAA/GDPR compliance is a plus.
  • Experience implementing automation for software development, such as automated traceability, documentation generation, or CI/CD pipelines supporting verification and validation processes.
  • Excellent problem-solving skills and ability to work in a fast-paced, collaborative environment.
  • Strong communication skills, with the ability to translate complex technical information for cross-functional teams.

Requirements

  • Experience working with FDA and international regulatory bodies for medical device clearance.
  • Familiarity with AI/ML development in healthcare.
  • Understanding of medical device cybersecurity and risk management practices.

Benefits

  • An avenue to make a positive impact on people's lives and their health.
  • The hourly rate for this role ranges from $48-$58 in local currency, depending upon experience and geographic location.
  • We are an equal-opportunity employer and value diversity at our company.
  • As part of the hiring process, successful candidates will undergo a background check in compliance with applicable federal, provincial, and state rules.
Before You Apply
๏ธ
๐Ÿ‡บ๐Ÿ‡ธ Be aware of the location restriction for this remote position: USA Only
โ€ผ Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.
Systems Engineer @Prenuvo
Artificial Intelligence
Salary usd 48 - 58 per..
Remote Location
๐Ÿ‡บ๐Ÿ‡ธ USA Only
Employment Type contract
Posted 1mth ago
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๐Ÿ‡บ๐Ÿ‡ธ Be aware of the location restriction for this remote position: USA Only
โ€ผ Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.
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