Medical Device Software Quality & Systems Engineer

United Pharma; Massachusetts; Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

United Pharma is seeking a Software Quality / Systems Engineer to support regulated medical device software development and lifecycle processes in Massachusetts. You will help ensure compliance with design controls, requirements management, traceability, risk management, verification, and DHF documentation.

The role collaborates with Software and Systems Engineering, Quality, and cross-functional teams to drive continual improvement and regulatory submissions.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Biomedical Engineering, or related technical field.

Responsabilités

• Support software development teams in medical device design controls and regulatory requirements.
• Support software development lifecycle activities per IEC 62304.
• Develop, review, maintain system- and software-level requirements.
• Establish traceability between requirements, risk controls, design outputs, and verification.
• Create and maintain requirements traceability matrices.
• Participate in design reviews and documentation reviews for compliance.
• Collaborate with Software Engineering, Systems Engineering, Quality, and cross-functional teams.
• Support Design History File (DHF) documentation and regulatory submission activities.
• Support software and system risk management activities.
• Identify documentation gaps and drive continuous improvement of quality and development processes.
• Support software verification and validation documentation.

Connaissances

Regulated environment experience

IEC 62304 familiarity

Requirements management

Traceability

Risk management

Documentation

Software verification & validation

Cross-functional collaboration

Formation

Engineering, Computer Science, Biomedical Engineering

Outils

Jama

Polarion

DOORS

Description du poste

United Pharma is seeking a Software Quality / Systems Engineer to support regulated medical device software development and lifecycle processes in Massachusetts. You will help ensure compliance with design controls, requirements management, traceability, risk management, verification, and DHF documentation.

The role collaborates with Software and Systems Engineering, Quality, and cross-functional teams to drive continual improvement and regulatory submissions.