Job Details

Job Description

The Lead Solutions Engineer is responsible for overseeing and leading technical design, implementation and delivery of projects aiming to launch new diagnostic tests and services. The lead solutions engineer acts as the technical owner for bioinformatics in a project, being responsible for the end-to-end solution from technical side. They also engage with the stakeholders of bioinformatics, leading communication and coordinating work, supporting project manager with status of the work, timelines and LOEs. They also solicit information within bioinformatics, working in tight collaboration with platform/product directors and teams to ensure alignment on technology strategy and that best fitting software systems are used in project level solution architecture. This position requires a proactive and flexible mindset, strong communication skills, and a commitment to continuous learning and innovation. This position also requires expertise in software development processes under FDA design control.

This professional will work in a remote capacity and must be located in the US.

Technical Leadership:

• Lead technical design, implementation and delivery of projects aiming to launch new diagnostic tests and services. Act as technical owner for your project, being responsible for the end-to-end solution from technical side.
• Work with cross-functional partners from business, operations, IT, R&D lab, geneticists, medical directors, and other bioinformatics stakeholders to create solutions that meet business and operational requirements.
• Lead solution architecture and interface design including system architecture for bioinformatics and detailed data flow mapping.
• Collaborate with stakeholders to ensure compliance of the solution with internal and external IT security and clinical policies and processes. Collaborate with quality team members across the organization to ensure compliance with FDA design control requirements.
• Work with bioinformatics domain leaders to select appropriate technology platforms for each step in the diagnostic process.
• Oversee end-to-end testing and diagnostic test validation activities with the project team.
• Lead the technical documentation and plan and execute handover to operations to ensure effective launch and operation of the solution.
• Work with project management and report on progress, analyze risks and escalate issues to ensure accurate project management.

Required WorkExperience:

• Proven experience as a Solutions Engineer, Solution Architect or Tech Lead with strong technical leadership skills and understanding of software architecture.
• Extensive experience in software design and implementation.
• Strong knowledge of API development, system integration, and scalable solutions.
• Proficiency in modern software development practices and tools (e.g., CI/CD pipelines, version control, testing frameworks).
• Experience with software development initiatives developed under FDA design control requirements.
• Excellent communication skills to engage with both technical and non-technical stakeholders.
• At least 5 years of experience working in a regulated industrial life sciences environment.
• At least 4 years of professional software development or technical engineering experience

Preferred Work Experience:

• Experience in mentoring and team development.

Physical and Mental Requirements:

• This role is required to collaborate with teams in US and EU, and at least 2 hour overlap during the respective stakeholder's business hours is expected
• This role supports our laboratory in the Dallas metro area and hybrid or near-site is preferred.

Knowledge and Skills:

• Thorough understanding of end-to-end diagnostic process including ordering, wet lab, dry lab, result interpretation and result and data delivery.
• Experience with solution design, system architecture, solution architecture, data flow modeling.
• Experience in leading technical design and implementation of complex projects.
• Experience with sequencing data analysis, bioinformatics, variant data analysis.
• Knowledge of bioinformatics tools and workflow managers for sequencing data analysis and quality control.
• Experience working with SQL and NoSQL databases.
• Experience with designing and working with application programming interfaces (e.g. JSON based RESTful APIs).
• Experience with designing and implementing solutions in the cloud. AWS experience is preferred.
• Experience of working in clinical diagnostics setting (regulations, controlled processes, diagnostic test validation, environment management).
• Solid understanding of human genetics and oncology in diagnostic setting.
• Solid understanding of web lab process for DNA sequencing and working with or developing LIMS systems.
• Infrastructure management: Terraform, AWS CDK.
• Architecture design: Microsoft Visio, DrawIO, similar for crafting architecture diagrams.
• Programming Languages: Python, javascript/typescript, R, etc.
• Containerizing: Docker
• Web Frameworks: Python Flask, React Native, Bootstrap
• Reporting: R Markdown, Jupyter Notebook
• Visualization: Experience with any of ggplot2/tidyverse, Plotly, matplot lib, Tableau, d3.js
• Exceptional problem-solving and analytical skills.
• Ability to lead, motivate, and collaborate effectively within a team.
• Flexibility to adapt to changing priorities in a fast-paced environment.
• A commitment to continuous learning and professional growth.

Education:

* Bachelor's degree in any of the Sciences, Engineering or a related field, or equivalent experience. (Required)

* Master's degree in Computer Science, Software Engineering, or a related field (Preferred)

Certifications:

No formal certification is required, but expertise in software architecture, API development, and modern development tools is essential.

* Development of software under FDA design control.

* Certifications in cloud platforms, architecture frameworks, or Agile methodologies (e.g., AWS Certified Solutions Architect, TOGAF, Certified ScrumMaster) are preferred.

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