Position Summary

We are seeking a Senior Software Engineer  to join our multi-disciplinary team, which is tasked to maintain a world-class, fully automated instrument system for high precision proteomic analysis. The title and salary will depend on software development and leadership experience. 

Duties and Responsibilities

• Operate as part of a team developing proteomic machines, algorithms, and machine and web user interfaces.  
• Lead projects and mentor junior software engineers. 
• Take full advantage of AI to accelerate development, review software, and fix bugs. 
• Partner with scientists to identify needs and deliver tailored workflows that streamline daily research. 
• Write clear user guides and conduct training sessions for algorithms and tools. 
• Collaborate with fellow developers, share best practices, and contribute to a culture of knowledge exchange and continuous improvement. 
• Step into evolving challenges and projects with enthusiasm, ensuring agility and success for the team. 

Qualifications

• Master’s degree in engineering or computer science. 
• Four years of C# programming experience is required, with Python, JavaScript/TypeScript, or C/C++ experience is desirable. 
• Proficiency in software engineering principles: version control (Git/GitHub), debugging, and comprehensive testing. 
• Experience working in an FDA-regulated software development environment is a plus. 
• Hands-on experience managing cloud infrastructure such as Azure and GitHub. 
• Experience building and consuming web in Blazor is a plus. 
• Strong database management skills. 
• Ability to work independently with a strong sense of ownership. 
• Excellent analytical, problem-solving, written, and verbal communication skills. 
• Proactive, adaptable, and eager to learn and grow with evolving technologies. 

The base salary range for this full-time position is $155,000 - $180,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process. 

Position Summary

We are seeking a detail-oriented and experienced Senior QA/Verification Specialist to join our team. In this role, you will be responsible for ensuring the quality, reliability, and regulatory compliance of our software products. You will design and execute comprehensive test cases, and develop FDA-compliant documentation in support of our product submissions and quality management system. 

Duties and Responsibilities

• Plan, design, and execute functional, integration, regression, and system-level software tests across multiple product releases. 
• Author and maintain detailed software test cases, test plans, and test reports in accordance with internal standards and regulatory requirements. 
• Review, and maintain FDA-required software documentation, including Software Requirements Specifications (SRS), Software Design Specifications (SDS), Hazard Analysis, Traceability Matrices, and Verification & Validation (V&V) protocols and reports. 
• Ensure documentation aligns with FDA guidance, including 21 CFR Part 11, 21 CFR Part 820, IEC 62304, and relevant ISO standards. 
• Collaborate with software developers, product managers, and regulatory affairs teams to define acceptance criteria and quality benchmarks. 
• Identify, document, and track software defects through resolution using issue tracking tools. 
• Participate in design reviews and risk analysis activities. 
• Support internal audits, external audits, and FDA inspections by ensuring documentation is accurate, complete, and audit-ready. 
• Contribute to continuous improvement of QA processes, tools, and documentation templates. 

Qualifications

• Bachelor's degree in Science or Engineering. 
• 6+ years of experience in quality assurance, preferably in a regulated industry (medical device, pharmaceutical, or life sciences). 
• Demonstrated experience writing and executing test cases and test plans. 
• Hands-on experience maintaining FDA regulatory documentation (e.g., 510(k)). 
• Understanding of FDA guidance documents, such as:  
  • Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
• Familiarity with risk management frameworks such as ISO 14971. 
• Proficiency with defect tracking and project management tools. 
• Strong written communication skills with meticulous attention to detail. 

The base salary range for this full-time position is $120,000 - $140,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process.