Software Quality / Systems Engineer

United Pharma; Massachusetts; On-site; USD 90,000 - 130,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Regulated environment experience

IEC 62304 familiarity

Requirements management

Traceability

Risk management

Documentation

Software verification & validation

Cross-functional collaboration

Education

Engineering, Computer Science, Biomedical Engineering

Tools

Jama

Polarion

DOORS

Job description

We are seeking a Software Quality / Systems Engineer to support the development of regulated medical device software. This role will help ensure compliance with medical device design controls and software lifecycle requirements while supporting requirements management, traceability, risk management, verification, and technical documentation.

Key Responsibilities:

• Support software development teams in following medical device design controls and regulatory requirements.
• Support software development lifecycle activities in accordance with IEC 62304.
• Develop, review, and maintain system- and software-level requirements and specifications.
• Establish and maintain traceability between requirements, risk controls, design outputs, and verification activities.
• Create and maintain requirements traceability matrices linking requirements to verification and validation testing.
• Participate in design reviews and documentation reviews to ensure compliance with quality requirements.
• 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 support continuous improvement of quality and development processes.
• Support software verification and validation documentation as required.

Skills and Qualifications:

• 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 industry experience strongly preferred.
• Familiarity with IEC 62304 software lifecycle processes.
• Understanding of medical device design controls and regulated documentation.
• Experience with requirements management and traceability tools such as Jama, Polarion, DOORS, or similar.
• Knowledge of FDA design control requirements and ISO 13485.
• Familiarity with ISO 14971 risk management preferred.
• Experience supporting software/system verification and validation documentation.
• Experience with Design History Files (DHF) or regulatory submissions preferred.