Job Title: Lead Product Support Engineer
Employment Status: Full-time
Office Hours: Monday - Friday; hybrid schedule
Location: Boston, Massachusetts
Compensation: $115,000-$145,000 base + variable + equity options
*OTE may be negotiated based on experience level

As a Lead Product Support Engineer at Ketryx, you will play a critical role in ensuring customer success across highly regulated industries. Acting as the primary technical liaison, you will provide expert-level support, resolve complex issues, and empower customers to achieve maximum value from the Ketryx platform. You’ll work hands-on with customers, Engineering, and Product teams to troubleshoot challenges, share best practices, and contribute insights that shape the future of our product.

This role is ideal for someone who thrives in a fast-paced environment, has a deep understanding of regulated software systems, and enjoys translating technical expertise into customer impact. In this position, you’ll apply your problem-solving skills and regulated-industry knowledge to help Ketryx advance its mission to impact 100 million patient lives by 2030. This position will be based in our Cambridge, MA office. 

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of employment Visas (including H-1B), F-1 visas, or Optional Practical Training (OPT) status at this time.

Responsibilities

Technical Support & Troubleshooting

• Serve as the primary point of contact for complex technical inquiries and product issues.
• Diagnose and resolve configuration, workflow, and integration challenges with speed and accuracy.
• Lead structured root-cause analysis and manage escalations to Engineering or Product teams when necessary.

Product Expertise & Enablement

• Develop deep technical expertise in the Ketryx platform and its applications in regulated environments.
• Provide training sessions, best-practice guidance, and technical documentation for customers.
• Maintain and improve internal and external knowledge bases, troubleshooting guides, and process documentation.

Customer Partnership & Success

• Collaborate closely with Client Operations teams to ensure technical barriers don’t impede adoption and value realization.
• Proactively identify opportunities for customers to optimize implementations and prevent recurring issues.
• Act as a trusted advisor by aligning technical support to customers’ compliance and business goals.

Feedback & Continuous Improvement

• Capture and synthesize customer feedback to inform product roadmap discussions.
• Contribute to product improvement initiatives based on real-world usage patterns and support trends.

Required Skills & Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related technical field, or equivalent professional experience.
• 3+ years of experience supporting software in regulated industries (medical device, pharmaceutical, biotech).
• Hands-on knowledge of quality management systems, validation processes, or compliance frameworks (FDA 21 CFR Part 820, ISO 13485, etc.).
• Proven experience troubleshooting and configuring complex SaaS or cloud-based platforms, including APIs and integrations.
• Exceptional ability to communicate technical concepts to both technical and non-technical audiences.
• Strong analytical and problem-solving skills with a systematic approach to troubleshooting.
• Excellent technical writing and documentation skills.

Preferred Skills

• Experience with software validation protocols (IQ/OQ/PQ) and verification practices.
• Background in quality management system implementation or auditing.
• Familiarity with regulatory submission processes (510(k), PMA, CE marking).
• Experience with data integrity requirements in regulated environments.
• Previous experience in technical account management, customer success, or similar customer-facing roles.
• Certifications in quality management (ASQ CQE, CQA) or project management (PMP, Agile).

Success Metrics

• Customer satisfaction and support ticket resolution times.
• First-call resolution rates and escalation effectiveness.
• Depth of product knowledge and quality of customer training.
• Contributions to product feedback and roadmap improvements.
  Documentation quality and knowledge base usage.

Keywords: medical device software, software as medical device, SaMD, software in a medical device, SiMD, software validation, software verification, technical support engineer, product support, SaaS support, regulated software, compliance software, quality management systems, QMS, FDA 21 CFR Part 11, ISO 13485, software troubleshooting, customer support engineer, API integrations, cloud platforms, enterprise support, life sciences software, software validation engineer, technical account management