Systems Engineer with (SaMD)

Job Title: Systems Engineer with (SaMD)

Job Location: Somerset NJ 08873 (Remote)

Onsite Requirements:

• Bachelor's or Master's degree in Biomedical Engineering, Systems Engineering, Computer Science, or related field.


• 3-7 years of experience in systems engineering for medical devices, preferably SaMD.


• Strong understanding of medical device regulatory standards (IEC 62304, ISO 14971, ISO 13485, FDA QSR).


• Experience with requirements management tools (e.g., Jama, DOORS, Polarion).


• Experience with AI/ML-based medical software.


• Exposure to cloud-based or mobile health platforms.


• Working knowledge of cybersecurity principles (e.g., ISO 27001, FDA premarket cybersecurity guidance).


• Knowledge of human factors and usability engineering (IEC 62366).
  

Job Description:

• We are seeking a highly motivated and experienced Software Systems Engineerto join our team in developing Software as a Medical Device (SaMD) This role bridges engineering, regulatory, and clinical domains to deliver compliant and innovative software products that improve patient outcomes. As a Software Systems Engineer, you will be responsible for the design, integration, and verification of software components across embedded systems, cloud platforms, and mobile applications that drive our medical device technologies. You will collaborate closely with hardware engineers, software developers, quality assurance, and regulatory teams to ensure our products are safe, effective, and compliant with medical industry standards (e.g., ISO 13485, IEC 62304, FDA 21 CFR Part 820).

KEY RESPONSIBILITIES:

• System Architecture & Design


• Define, develop, and manage system-level requirements for SaMD products.


• Collaborate with software, hardware, and quality teams to ensure cohesive system architecture.


• Perform system decomposition and traceability from user needs to software requirements.


• Develop and maintain system and software architecture for medical device products.


• Define and document software system requirements and interfaces based on user needs, regulatory requirements, and business goals.


• Work with cross-functional teams to ensure seamless integration of software with hardware and other subsystems.


• Lead risk analysis, failure mode assessments, and cybersecurity reviews.


• Oversee software verification and validation planning and execution.


• Ensure compliance with relevant standards and regulations (e.g., IEC 62304, ISO 14971, ISO 27001).


• Contribute to design history file (DHF) and technical file documentation.


• Support regulatory submissions (FDA, CE, etc.) through generation and review of technical documentation.


• Participate in Agile/Scrum development activities, including sprint planning, reviews, and retrospectives.

Requirements Engineering

• Elicit and document user needs and system requirements in compliance with IEC 62304 and ISO 13485.


• Maintain requirements traceability throughout the product lifecycle.

Risk Management

• Contribute to hazard analysis, risk assessments, and mitigation strategies per ISO 14971.


• Support cybersecurity risk assessments for connected SaMD products.

Verification & Validation

• Support system integration, verification, and validation planning and execution.


• Ensure V&V activities align with FDA, MDR, and other regulatory requirements.

Regulatory & Quality

• Work closely with regulatory and quality teams to support documentation for FDA submissions (510(k), De Novo) and CE marking.


• Ensure system development aligns with applicable standards, including IEC 62304, ISO 14971, ISO 13485, and FDA 21 CFR Part 820.

Cross-functional Collaboration

• Act as a technical liaison between software developers, clinical experts, quality engineers, and product management.


• Participate in Agile development processes, including sprint planning, reviews, and retrospectives.

REQUIRED:

• Bachelor's or Master's degree in Biomedical Engineering, Systems Engineering, Computer Science, or related field.


• 3-7 years of experience in systems engineering for medical devices, preferably SaMD.


• Strong understanding of medical device regulatory standards (IEC 62304, ISO 14971, ISO 13485, FDA QSR).


• Experience with requirements management tools (e.g., Jama, DOORS, Polarion).


• Familiarity with Agile development and continuous integration workflows.


• Excellent communication and documentation skills.

Preferred Qualifications:

• Experience with AI/ML-based medical software.


• Exposure to cloud-based or mobile health platforms.


• Working knowledge of cybersecurity principles (e.g., ISO 27001, FDA premarket cybersecurity guidance).


• Knowledge of human factors and usability engineering (IEC 62366).

• **3rd party and subcontract staffing agencies are not eligible for partnership on this position. 3rd party subcontractors need not apply.


• This position requires candidates to be eligible to work in the United States, directly for an employer, without sponsorship now or anytime in the future**