Software Quality Engineer

United Pharma; Massachusetts; On-site; USD 90,000 - 120,000; Full time

Job summary

United Pharma is seeking a motivated Software Quality / Systems Engineer to support the development of regulated medical device software. This role ensures compliance with design controls and software lifecycle standards while supporting requirements management, traceability, risk management, and regulatory documentation across cross-functional teams.

The ideal candidate has hands-on experience in a regulated product environment, familiarity with IEC 62304, and proficiency with Jama, Polarion,

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 experience preferred.
• Familiarity with IEC 62304 software lifecycle standard.
• Understanding of medical device design controls and regulated documentation practices.
• Experience with requirements management and traceability tools such as Jama, Polarion, DOORS, or similar platforms.

Responsibilities

• Support software development teams in following medical device design control processes and applicable regulatory standards.
• Assist with implementing and maintaining the software development lifecycle in accordance with IEC 62304.
• Develop, review, and maintain system- and software-level requirements documentation and specifications.
• Establish and maintain traceability between requirements, risk controls, design outputs, and verification activities.
• Create and maintain traceability matrices linking requirements to verification and validation testing.
• Participate in design reviews and documentation reviews to ensure compliance with quality and regulatory requirements.
• Collaborate with software engineering, systems engineering, quality, and other cross-functional teams throughout product development.
• Assist with preparing and maintaining documentation for Design History Files (DHF) and regulatory submissions.
• Support software-related risk management activities, including the assessment of software features and system requirements.
• Help identify documentation gaps and support continuous improvement of development and quality processes.

Skills

Regulated environment

Traceability

Requirements management

Technical documentation

Cross-functional collaboration

Education

Bachelor’s degree in Engineering/CS/BME or related

Tools

Jama

Polarion

DOORS

Job description

We are seeking a motivated 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 standards while supporting requirements management, traceability, risk management, and technical documentation across cross-functional engineering teams.

The ideal candidate has experience working in a regulated product development environment and is familiar with IEC 62304 software lifecycle processes, medical device design controls, requirements management, and verification documentation.

Key Responsibilities

• Support software development teams in following medical device design control processes and applicable regulatory standards.
• Assist with implementing and maintaining the software development lifecycle in accordance with IEC 62304.
• Develop, review, and maintain system- and software-level requirements documentation and specifications.
• Establish and maintain traceability between requirements, risk controls, design outputs, and verification activities.
• Create and maintain traceability matrices linking requirements to verification and validation testing.
• Participate in design reviews and documentation reviews to ensure compliance with quality and regulatory requirements.
• Collaborate with software engineering, systems engineering, quality, and other cross-functional teams throughout product development.
• Assist with preparing and maintaining documentation for Design History Files (DHF) and regulatory submissions.
• Support software-related risk management activities, including the assessment of software features and system requirements.
• Help identify documentation gaps and support continuous improvement of development and quality processes.

Required Qualifications

• Bachelor’s degree in Engineering, Computer Science, Biomedical Engineering, or a related technical field.
• 3–5 years of experience supporting software or systems development in a regulated environment; medical device experience is strongly preferred.
• Familiarity with the IEC 62304 software lifecycle standard.
• Understanding of medical device design controls and regulated documentation practices.
• Experience with requirements management and traceability tools such as Jama, Polarion, DOORS, or similar platforms.
• Strong attention to detail and excellent technical documentation skills.
• Ability to collaborate effectively with cross-functional engineering and quality teams.

Preferred Qualifications

• Experience in medical device or other regulated product development environments.
• Familiarity with FDA design control requirements and ISO 13485 quality systems.
• Exposure to software or systems verification and validation documentation.
• Familiarity with risk management processes based on ISO 14971.
• Experience supporting Design History File documentation or regulatory submissions.