Title : Systems Engineer
Location: Boston or Raynham, MA Hybrid; Onsite Preferred
Employment Type: Contract W2
Duration: 6 Months
Experience: 3 5 Years
About the Role
We are seeking a Systems Engineer to support the development of regulated medical device software. This role will focus on requirements management, traceability, risk management, design controls, verification documentation, and compliance with software lifecycle processes.
Responsibilities
- 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.
Required 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 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.
Preferred Qualifications
- Medical device or other regulated product development experience.
- Knowledge of FDA Design Control requirements and ISO 13485.
- Experience with software/systems verification and validation documentation.
- Knowledge of ISO 14971 risk management.
- Experience supporting DHF documentation or regulatory submissions.
Salary
The hourly rate for this position is $44 $49/hr W2 ( DOE )
Benefits:
This is a contract position and does not include employer-provided benefits.
Equal Opportunity Employer:
We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Background Check:
Background checks may be conducted in accordance with applicable law.
Work Authorization:
Applicants must be authorized to work in the United States.