Job Title: Client Operations Engineer   Employment Status: Full-time Office Hours: Monday - Friday, 8am - 5pm, in-office Location: Boston, Massachusetts Compensation: $65,000 - $90,000 *compensation may be negotiated based on experience level <hr /> Ketryx is on a mission to save and improve lives by making medical software and AI safe, secure, and reliable. We empower software teams building medical applications to create compliant, high-quality products that patients and providers around the world can trust. By automating the complex documentation and quality processes that slow innovation, we help our customers build safer, more innovative medical software—faster. As a leader in the emerging field of AI/ML in MedTech, we’re building a Client Operations team that blends technical excellence with empathy, service, and growth. We’re looking for Client Operations Engineers who are eager to learn, excited by complexity, and driven to make a real impact through meaningful work. If you’re curious, team-oriented, and motivated to grow in a mission-driven environment, we’d love to meet you. <h2>The role</h2> We’re growing our Client Operations team to support an expanding group of customers who rely on Ketryx to power their safety-critical development processes. As a Client Operations Engineer, your role is to help our customers thrive—by becoming a trusted partner, delivering exceptional service, and applying technical and quality expertise to solve meaningful problems. In this role, you’ll support customers from onboarding through long-term partnership. You’ll configure and tailor the Ketryx platform to meet their needs, help optimize quality and regulatory workflows, and ensure they get the most from our technology. You’ll also collaborate with internal teams to shape the product and improve how we work—contributing to solutions that define the future of medtech. This is a foundational role in achieving our ambitious goal of impacting over 20 million patient lives in 2024. You’ll help bring safer, more innovative technologies to the world—while growing alongside a team that values curiosity, humility, and service. If you thrive in fast-paced, mission-driven environments and are looking to build something that matters, we’d love to hear from you. <h2>About you</h2> You’re energized by meaningful work and driven to help others succeed. You bring a strong sense of care and curiosity to everything you do—whether learning a complex system, supporting a teammate, or helping a customer solve a challenging problem. You have experience in regulated environments or technical systems, and you understand the importance of precision, safety, and process. You communicate clearly, think critically, and thrive in dynamic, fast-paced settings where trust, growth, and collaboration matter. You’re humble, thoughtful, and eager to grow—ready to take ownership of your work while contributing to something larger than yourself. If this sounds like you, we’d love to meet you. <h2>Responsibilities (General)</h2> Support Client Success Assist with client onboarding, training, and support—ensuring customers are set up for long-term success with the Ketryx platform. Help solve real problems in regulated environments with clarity and care. Configure and Optimize the Platform Learn the Ketryx platform inside and out. Support product configuration, data workflows, and documentation processes tailored to safety-critical applications and customer needs. Contribute to Technical Problem Solving Work closely with clients and teammates to troubleshoot issues, improve workflows, and identify opportunities for optimization. Escalate challenges thoughtfully and follow through with reliability. Collaborate on Product Development Share insights from real-world customer experience to help shape product direction. Participate in feedback cycles with Product and Engineering teams, helping us build tools that truly work. Support Quality and Compliance Efforts Help maintain clear, accurate, and compliant documentation within the Quality Management System (QMS). Support internal process improvements and reinforce our shared commitment to quality. Grow as a Professional Take ownership of your learning and development. Build the skills, habits, and maturity needed to become a trusted contributor—both to our clients and to the Ketryx team. <h2>Required Skills (General)</h2> <ol> <li>Regulated Environment Experience: Previous experience working within a regulated environment on a validated product. Examples include roles like Quality Engineer, Quality Manager, or Software Developer in the medical device, pharma, or biotech industries. </li> <li>Product Configuration and Technical Literacy: Familiarity with configuring technical systems, software architecture, and data flows. Experience with software V&amp;V (Verification and Validation) protocols is a plus. </li> <li>Customer-Focused Problem Solving: Strong interpersonal skills with the ability to build trust, solve complex problems, and communicate technical concepts clearly to clients. </li> <li>Process Discipline and Continuous Improvement: Experience in process execution, manufacturing, or operations with a focus on quality and efficiency. </li> <li>Communication Skills: Strong technical writing skills, with the ability to produce clear, concise documentation for both internal and external audiences. </li> <li>Team Orientation: Effective collaborator, able to work in cross-functional teams and adapt to dynamic environments. </li> <li>Educational Background: Bachelor’s degree in a relevant field or equivalent work experience.</li> </ol> <h2>Responsibilities (QA/RA)</h2> Support Client Success: Assist with client onboarding, training, and support—ensuring customers are set up for long-term success with the Ketryx platform. Help solve real problems in regulated environments with clarity and care. Configure and Optimize the Platform: Learn the Ketryx platform inside and out. Support product configuration, data workflows, and documentation processes tailored to safety-critical applications and customer needs. Regulatory and Technical Expertise: Working knowledge of regulatory standards (e.g. ISO 13485, ISO 14971, FDA QSR) and apply them in the configuration of validated systems. Support clients in aligning their processes with safety and compliance expectations. Document Ownership and Process Control: Contribute to drafting and managing SOPs, validation records, and other quality documentation. Ensure accuracy, clarity, and alignment with internal QMS standards and regulatory requirements. Contribute to Technical Problem Solving: Work closely with clients and teammates to troubleshoot issues, improve workflows, and identify opportunities for optimization. Escalate challenges thoughtfully and follow through with reliability. Collaborate on Product Development: Share insights from real-world customer experience to help shape product direction. Participate in feedback cycles with Product and Engineering teams, helping us build tools that truly work. Support Quality and Compliance Efforts: Help maintain clear, accurate, and compliant documentation within the Quality Management System (QMS). Support internal process improvements and reinforce our shared commitment to quality. Grow as a Professional: Take ownership of your learning and development. Build the skills, habits, and maturity needed to become a trusted contributor—both to our clients and to the Ketryx team. <h2>Required Skills (QA/RA)</h2> <ol> <li>Regulated Environment Experience: Previous experience working within a regulated environment on a validated product. Examples include roles like Quality Engineer, Quality Manager, or Software Developer in the medical device, pharma, or biotech industries. </li> <li>Document Ownership: Skilled in drafting, reviewing, and managing policies, work instructions, and SOPs within formal quality frameworks. </li> <li>Product Configuration and Technical Literacy: Familiarity with configuring technical systems, software architecture, and data flows. Experience with software V&amp;V (Verification and Validation) protocols is a plus. </li> <li>Customer-Focused Problem Solving: Strong interpersonal skills with the ability to build trust, solve complex problems, and communicate technical concepts clearly to clients. </li> <li>Technical and Regulatory Expertise: Ability to read, interpret, and apply technical standards and regulations relevant to safety-critical systems. </li> <li>Process Discipline and Continuous Improvement: Experience in process design, manufacturing, or operations with a focus on quality and efficiency. </li> <li>Communication Skills: Strong technical writing skills, with the ability to produce clear, concise documentation for both internal and external audiences. </li> <li>Team Orientation: Effective collaborator, able to work in cross-functional teams and adapt to dynamic environments. </li> </ol> Educational Background: Bachelor’s degree in a relevant field or equivalent work experience. Keywords: customer success, client operations, professional services, systems engineer, Solutions Architect, Software as a Medical Device, SaMD, product management, technology, client management, quality, regulatory, system engineer, B2B, regulation, task management, project management, Greater Boston, MA, SQL, KQL, python, java<div><h3>What We Offer</h3> <ul> <li>Competitive compensation</li> <li>Generous stock options possible</li> <li>Work in an exciting field with a positive impact on the world</li> <li>Opportunity to learn and grow as part of a global team</li> <li>Hybrid work model (mix of work from home and office is possible)</li> <li>Generous PTO for full-time</li> </ul> Ketryx is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances Ketryx is saving and improving lives by making medical software safe and reliable. We empower software teams building medical applications to create safe, secure, and compliant products used by patients and providers worldwide. We believe that, by automating much of the documentation and quality processes, teams will be able to produce safer and more innovative medical software faster. Ketryx is at the forefront of helping teams incorporate AI/ML into medical software and that’s why we need you!  </div>