Software Systems Engineer

Tucson, AZ - USA

Monthly Salary: $ 50 - 50

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

Our client a world leader in life sciences and biotechnology is looking for a Software Systems Engineer based out of Tucson AZ.

Job Duration: Long Term Contract (Possibility Of Extension)

Pay Rate: $39 - $42/hr on W2

Company Benefits: Medical Dental Vision Paid Sick leave 401K

A Software Systems Engineer to lead the definition development and risk management of software for in-vitro diagnostic (IVD) instruments. This role focuses on ensuring reliable and compliant software systems that support advanced cancer diagnostic solutions. The Systems Engineer will drive software requirements perform risk analysis and collaborate across functions including R&D Quality Regulatory and Operations.

Responsibilities

Develop and manage software requirements and system architectures for IVD instruments.
Conduct risk analysis trade-off studies and impact assessments to ensure regulatory compliance.
Support system integration verification and validation activities for software products.
Ensure alignment with FDA ISO 13485 ISO 14971 and IEC 62304 regulatory standards.
Collaborate with cross-functional teams (R&D Quality Marketing Operations and Regulatory) to translate business and user needs into technical specifications.
Manage configuration control defect tracking and change management throughout the development lifecycle.
Contribute to design reviews root cause investigations and continuous improvement efforts.
Provide technical expertise on software reliability usability and manufacturability.
Participate in technology and competitive analyses to inform product innovation.

Qualifications

Bachelors degree in Engineering Biomedical Sciences Computer Science or related technical field.
4 years of experience in systems or software engineering (or Masters 2 years PhD 01 year).
Proven experience in:
- Writing and managing software/system requirements
- Performing risk management and analysis
- Working within a regulated medical device environment
- Managing verification and validation (V&V) activities
Strong knowledge of systems engineering principles trade-off analysis and configuration management.
Familiarity with FDA ISO and IVD standards.

If interested please send us your updated resume at

/sanya @

Required Skills:

Data center Hardware

Required Education:

Bachelors

Our client a world leader in life sciences and biotechnology is looking for a Software Systems Engineer based out of Tucson AZ. Job Duration: Long Term Contract (Possibility Of Extension)Pay Rate: $39 - $42/hr on W2 Company Benefits: Medical Dental Vision Paid Sick leave 401KA Software Systems Engin...