Regulated Medical Device Systems Engineer

Intellectt INC; Massachusetts; Ibrido; USD 61.000 - 68.000; Tempo pieno

Descrizione del lavoro

Intellectt INC is seeking a Systems Engineer to support the development of regulated medical device software in Boston or Raynham, MA, on a hybrid basis with onsite preference. This contract W2 role focuses on requirements management, traceability, risk management, design controls, verification documentation, and lifecycle compliance.

The role requires a Bachelor's in engineering or related field and 3–5 years in a regulated environment, with IEC 62304 familiarity and experience with

Competenze

• Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, or related technical field.
• 3–5 years of experience supporting software or systems development in a regulated environment.
• Medical device experience strongly preferred.
• Familiarity with IEC 62304.
• Understanding of medical device Design Controls and regulated documentation.
• Experience with requirements management and traceability tools such as Jama, Polarion, DOORS, or similar.
• Strong technical documentation and attention to detail.
• Ability to work effectively with cross-functional engineering and quality teams.

Mansioni

• Support software development teams with medical device design control and regulatory requirements.
• Support software development lifecycle activities aligned with IEC 62304.
• Develop, review, and maintain system- and software-level requirements and specifications.
• Establish traceability between requirements, risk controls, design outputs, and verification activities.
• Create and maintain requirements traceability matrices for verification and validation testing.
• Participate in design and documentation reviews to ensure quality and regulatory compliance.
• Collaborate with Software Engineering, Systems Engineering, Quality, and other cross-functional teams.
• Support Design History File (DHF) documentation and regulatory submission activities.
• Support software-related risk management activities and assess system/software requirements.
• Identify documentation gaps and support continuous improvement initiatives.

Conoscenze

Requirements management

Traceability

Regulated environment

Medical device experience

IEC 62304

Formazione

Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, or related technical field

Strumenti

Jama

Polarion

DOORS

Descrizione del lavoro

Intellectt INC is seeking a Systems Engineer to support the development of regulated medical device software in Boston or Raynham, MA, on a hybrid basis with onsite preference. This contract W2 role focuses on requirements management, traceability, risk management, design controls, verification documentation, and lifecycle compliance.

The role requires a Bachelor's in engineering or related field and 3–5 years in a regulated environment, with IEC 62304 familiarity and experience with