Systems Engineer – Medical Device

Now Hiring: Systems Engineer – Medical Device (SaMD) Remote (Periodic Travel to New Jersey Required) Contract Duration: 9 Months

Position Overview: We are seeking a Systems Engineer with proven experience in the Medical Device industry, specifically in Software as a Medical Device (SaMD) . This role involves gathering and analyzing requirements, driving cross-functional collaboration, and ensuring compliance with regulatory standards in a dynamic, agile development environment.

Key Responsibilities:

Gather, analyze, and document system requirements

Collaborate with cross-functional teams including Software, Hardware, QA, and Regulatory Affairs

Support development and validation activities in a regulated medical device environment

Ensure traceability and compliance with design control standards

Required Skills & Experience:

Strong experience with requirements engineering and traceability

Hands-on with tools like Jama , DOORS , or Polarion

Experience working with Agile/Scrum in regulated environments

Familiarity with regulatory standards including:

FDA QSR

IEC 62304

ISO 13485

ISO 14971

Background in Software as a Medical Device (SaMD) preferred