Software Quality / Systems Engineer

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.