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Job Description
To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL www.linkedin.com/in/deepakarya8a79aa22a/ ), email your updated resume at Email deepak.arya@collabera.com . Thank you!
Pay Range:
$50 to $60 an hour.
Client Industry:
Medical Devices Job Mode:
Onsite Duration:
06 Month Contract (Possible Extension- based on performance and business needs)
Job Summary:
We are seeking a Senior Software Systems Engineer to support the development of complex regulated medical technology solutions. This position will lead requirements engineering activities and serve as a technical expert responsible for translating stakeholder needs into detailed software and system requirements. The ideal candidate will collaborate with multidisciplinary teams to ensure alignment across development, verification, validation, quality, and regulatory functions. This role requires strong experience with design controls, risk management, and software lifecycle processes within regulated environments. The engineer will play a critical role in delivering compliant, high quality products while driving technical excellence and cross functional collaboration.
Key Responsibilities:
Collaborate with engineering, clinical, regulatory, quality, and commercial stakeholders to define product objectives and requirements. Translate user needs and intended use into detailed software requirements, system requirements, functional specifications, and interface definitions. Facilitate design reviews and technical reviews to ensure alignment with architecture, quality processes, and compliance requirements. Partner with systems engineering, software development, and verification and validation teams throughout the product lifecycle. Support risk management activities including hazard analysis, FMEA, and risk assessments. Ensure risk controls are appropriately documented within requirements, design outputs, and verification activities. Provide visibility into technical progress, risks, compliance status, and system performance. Coordinate activities across global engineering teams to resolve technical dependencies and support project execution. Support adherence to quality system processes, design controls, configuration management, and change management practices.
Required Qualifications:
Bachelor's degree in Systems Engineering, Biomedical Engineering, Software Engineering, Computer Science, or a related technical discipline with 5 to 6 years of relevant experience. Master's degree in a related technical discipline with a minimum of 4 years of relevant experience. Experience working in regulated product development environments such as medical devices, aerospace, automotive, or similar industries. Demonstrated experience converting business objectives and stakeholder requirements into detailed software requirements and functional specifications. Working knowledge of design control processes. Working knowledge of configuration management, defect tracking, and change management processes. Strong communication and collaboration skills. Ability to work independently within a matrixed organization.
Preferred Qualifications:
Experience with connected or software enabled medical devices. Knowledge of cloud platforms including AWS and Azure. Experience with mobile application ecosystems. Experience using requirements management and defect tracking tools such as DOORS, JIRA, or similar platforms. Familiarity with
IEC 62304, IEC 60601, ISO 14971, FDA
design controls, and related standards. Experience supporting software lifecycle processes within regulated environments.
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)
