10+ Years We are looking for a System Engineer with strong experience in product development, software engineering, cloud applications, AI validation, and the biotechnology/medical device domain. The role involves working with global development teams and serving as the onsite technical interface between the customer and offshore teams. Required Skills 10+ years of experience in Product Development / Software Engineering Strong experience with C#, Python, REST APIs, TCP/IP, UDP Strong AWS experience: ECS, RDS, Lambda, S3, EC2, IAM, SSM, CloudWatch Experience designing scalable, secure, cloud-based applications Experience with AI-native platforms and AI validation frameworks Experience with Embedded Validation & Verification Strong understanding of SDLC, System Requirements, PRD, SyRS and RTM Experience with Postgre
SQL, ETL, ORM
Experience with Docker, Git/Bitbucket, Jenkins and CI/CD Experience with Terraform, CloudFormation or Pulumi Knowledge of HTML5, JavaScript and CSS Knowledge of FDA, CLSI, CASFM/EUCAST and security/compliance requirements Biotechnology / Medical Device / Life Sciences domain experience preferred Experience working with R&D, QA, Regulatory Affairs, Manufacturing, Clinical and Marketing teams Strong communication and client-facing skills Experience managing or coordinating global development teams Key Responsibilities Translate business and product requirements into solution architectures and implementation approaches Drive system design, validation, requirements traceability and issue resolution Coordinate with onsite customers and offshore engineering teams Participate in design reviews and technical decision-making Support product development, verification, validation and regulatory compliance Serve as the primary onsite technical coordinator between customer and offshore teams
Pay:
$40.00 - $45.00 per hour Expected hours: 40.0 per week