Current openings at Noah Medical

About The Team: We are seeking a Principal SW Engineer to lead our Cloud Services initiatives on AWS, focusing on developing secure, scalable cloud services that power our next-generation medical robotics platform. This role will architect and implement solutions leveraging AWS IoT and other cloud services, and collaborate across teams to ensure seamless integration between our robotic systems and cloud infrastructure. A Day In The Life Of Our Principal Software Engineer - Cloud Services: Design and implement cloud-native architectures using AWS services including IoT Core for medical device connectivity Lead development of secure device management, telemetry collection, and remote monitoring capabilities Architect scalable microservices using AWS serverless technologies Ensure compliance with medical device regulations (FDA, HIPAA) in cloud implementations Collaborate with robotics, firmware, and clinical teams to define and implement cloud service requirements Drive best practices for security, reliability, and observability in cloud infrastructure Create and maintain technical documentation for cloud systems and implementations About You: Bachelor's degree in Computer Science, Engineering, or related field 10+ years of experience in cloud architecture and development 3+ years of hands-on experience with AWS services Strong experience with serverless architecture and microservices Expertise in C#, C++ and Python is a nice to have Experience with Infrastructure as Code (Terraform/CloudFormation) Knowledge of medical device security and compliance requirements Preferred Qualifications: Master's degree in related field AWS certifications (Solutions Architect, IoT Specialty) Experience in medical device or healthcare technology industry Experience with real-time data processing and MQTT protocols Knowledge of medical device regulatory requirements Experience with CI/CD pipelines and DevOps practices Technical Skills: AWS Services: IoT Core, Lambda, API Gateway, DynamoDB, S3 Security: AWS IAM, KMS, X.509 certificates, Security Groups Development: REST APIs, MQTT, WebSocket protocols Infrastructure: Terraform/CloudFormation, CI/CD pipelines Monitoring: CloudWatch, AWS IoT Analytics Databases: DynamoDB, RDS, TimeStream Leadership Skills: Strong system architecture and design capabilities Excellence in technical documentation and communication Experience in agile development methodologies Ability to mentor engineering talent Strong problem-solving and decision-making abilities Skill in translating business requirements into technical solutions Workplace Type: Hybrid (Local to San Jose preferred but open to remote in the Pacific or Mountain time zones) Benefits & Perks (For Full Time Employees): Competitive Salary Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options Equity & Bonus Program Life Insurance (company paid & supplemental) and Disability insurance Mental health support through medical insurance programs Legal and Pet Insurance 12+ paid holidays, 15-20 days of PTO + use-what-you-need sick days Paid parental leave In-office snacks and beverages  In-office lunch stipend Learning & Development Opportunities: On-demand online training and book reimbursement Team building and company organized social and celebration events #LI-Hybrid 

About The Team The Quality team is an integral part of ensuring products, services, and processes are of the highest quality and meet customer and regulatory requirements. We are a team of detail-oriented professionals who take pride in meticulously assessing processes, products, and services to identify and rectify issues, ensuring the utmost quality and customer satisfaction. If you share our passion for maintaining the highest standards of quality and are dedicated to making a positive impact, we invite you to consider joining our Quality Assurance Team. Together, we can continue to elevate our organization's quality standards and provide unparalleled value to our customers and stakeholders.  A Day In The Life Of Our Manager, Complaints and Post-Market Perform a wide variety of activities to ensure compliance with applicable quality and regulatory requirements. Oversee day-to-day activities of the complaint handling team, ensuring complaints are handled promptly and accurately Work closely with Product Quality Engineering team to ensure that investigations and complaints are completed and closed out in a timely manner Review complaint files to ensure all complaint elements have been addressed and properly documented within the complaint file Manage adverse event reporting activities including decision rationale and reporting documentation. Submit adverse event  reports to regulatory authorities Manage complaint metrics and analytics including trending and measure against statistical trend limits Schedule post market surveillance reviews and complete post market surveillance reports based on applicable regulatory requirements Coordinate with clinical, marketing, sales, regulatory, and R&D to obtain their respective post market surveillance information based on regulatory requirements Initiate risk file updates based on post market data such as complaint rates and new hazards Review customer inquiries and service reports for potential complaints Identify and escalate complaints for potential adverse event reporting decisions Perform complaint case final reviews for closure Manage complaint handling team activities and provide guidance as needed Review, revise and create SOPs (Standard Operating Procedures) and/or WIs(Work Instructions) related to complaint handling, adverse event reporting Prepare SOPs and WIs and gather data as needed to support ISO 13485:2016 clause 8.2.1 Feedback and for OUS regulatory requirements Assist in audits (internal and external). May also conduct internal audits as needed. Other QMS activities as assigned About You At minimum a BS degree in a technical field such as engineering, computer science, or a science related discipline. 5+ years of complaint-handling experience in the medical device industry. Ability to manage others, their work, and your own multiple competing priorities. Working knowledge of the entire complaint handling process from intake, investigation, closure, and reportability assessments. Strong Working knowledge of US FDA 21 CFR 820.198, 803, and 806 requirements. Basic Working knowledge of OUS adverse event reporting requirements. Basic Working knowledge of OUS post market surveillance requirements. Working statistical knowledge as it pertains to trending Intermediate understanding of mechanical and software aspects of medical devices. Benefits & Perks (For Full Time Employees): Competitive Salary Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options Equity & Bonus Program Life Insurance (company paid & supplemental) and Disability insurance Mental health support through medical insurance programs Legal and Pet Insurance 12+ paid holidays, 15-20 days of PTO + use-what-you-need sick days Paid parental leave In-office snacks and beverages  In-office lunch stipend Learning & Development Opportunities: On-demand online training and book reimbursement Team building and company organized social and celebration events #LI-Onsite