Vital Bio

Frontend Engineer

• Lead the design, development, and optimization of front end applications and internal tools for VitalOne, the flagship diagnostic device.
• Participate in all phases of UI design: from initial concept and rapid prototyping to testing, iteration, and final deployment.
• Develop and integrate UI components using modern JavaScript frameworks (Vue, React, or Angular), emphasizing usability, scalability, and compliance.
• Build and maintain automated test suites for front end applications and support manual verification efforts.
• Collaborate closely with software, hardware, and product teams to ensure seamless integration and delivery.
• Champion best practices in project documentation, version control, and code review.
• Support sustainable engineering functions to help shape a reliable, regulatory-compliant front end for medical technologies.

Front-End Software Engineer

Systems Engineer

• Translate product-level and user requirements into clear and actionable technical specifications for engineering teams.
• Define and maintain system-level design inputs that align with regulatory, usability, and performance requirements.
• Ensure technical specifications are traceable to user needs and regulatory standards (e.g., ISO 13485, IEC 62304, FDA 21 CFR 820).
• Develop and maintain system architecture documentation, ensuring alignment across hardware, software, mechanical, and assay disciplines.
• Serve as a technical liaison between R&D, software, mechanical, electrical, and assay teams to ensure seamless integration.
• Support design reviews, system modeling, and prototype evaluations.
• Lead and execute system-wide risk analysis activities (e.g., FMEA, Fault Tree Analysis, Hazard Analysis).
• Ensure system design and risk assessments comply with IVD regulatory requirements such as ISO 14971.
• Collaborate with Quality Assurance and Regulatory Affairs teams to support submission documentation.
• Conduct impact analysis for proposed design changes, ensuring modifications are assessed for potential risks and unintended consequences.
• Work with cross-functional teams to implement design changes while maintaining system integrity and compliance.
• Continuously refine system-level documentation to reflect the latest design decisions and risk assessments.

Engineer

• Support the transfer of new products and processes from engineering and assay development into cGMP manufacturing
• Assist in designing, developing, and refining assembly processes and workflows for reagent-containing consumables and instruments, including those with molded plastic components
• Design, implement and qualify assembly fixtures and tooling to facilitate the manufacturing process
• Help document and implement process changes, standard operating procedures (SOPs), work instructions, and acceptance criteria to ensure consistent, compliant operations
• Participate in process validation and equipment qualification activities (IQ, OQ, PQ) under supervision
• Contribute to the investigation and troubleshooting of manufacturing issues, assisting with root cause analysis and implementation of corrective actions
• Gather, analyze, and report manufacturing data to support process optimization, yield improvements, and cost reduction initiatives
• Help maintain and update cGMP manufacturing records and documentation in compliance with ISO 13485 and FDA requirements
• Work collaboratively with engineering, assay development, and quality teams to address daily production needs and support ongoing improvement projects

Associate Manufacturing Engineer

• Lead the transfer of new products and manufacturing processes from engineering and assay development into a cGMP manufacturing environment.
• Design, develop, and implement robust manufacturing processes and scale-up activities for combination consumable assemblies and diagnostic instruments.
• Provide DFx input to new designs and processes, ensuring manufacturability and scaleability.
• Define and evaluate different assembly strategies, introduce equipment and process automation, and maintain cost-effective, repeatable operations.
• Develop process flow maps, optimize assembly sequences applying lean principles, and recommend new processes/equipment.
• Develop and execute design transfer plans, identify gaps, and establish plans to close gaps.
• Serve as manufacturing SME, identifying risks and mitigation strategies related to process steps, raw materials, and product performance.
• Collaborate with engineering, assay development, manufacturing and supply chain teams for inventory management and prototype supply.
• Establish and maintain manufacturing controls and documentation, including SOPs, work instructions, acceptance plans, and compliance with ISO 13485 and cGMP.
• Plan and execute validation protocols (IQ, OQ, PQ) and support procurement, installation, qualification, and maintenance of equipment.
• Perform root cause analysis for manufacturing failures and implement process improvements.
• Proactively identify and drive opportunities for continuous improvement in manufacturing operations.

Manufacturing Engineer II

Application Engineer

• Develop robust applications in Rust for real-time medical devices running on embedded Linux.
• Implement and optimize algorithms for data processing in regulated healthcare environments.
• Ensure seamless integration between software and hardware components as well as cloud backend services.
• Work closely with our science team to translate requirements into tailored software solutions.
• Collaborate with systems and hardware engineers to integrate software with embedded systems.
• Ensure all software adheres to medical device regulations (e.g., FDA, ISO 13485).
• Drive the adoption of best practices in software engineering, including automated testing, CI/CD pipelines, and robust version control strategies.
• Provide technical guidance to junior engineers and lead initiatives to drive continuous improvement.
• Stay at the forefront of advancements in Rust programming, embedded systems, and medical device development.
• Contribute to the validation, documentation, and testing processes to align with internal quality systems.

Senior Application Engineer, Rust

Project Manager

• Facilitate and drive the execution of manufacturing-focused development, design transfer, and facility expansion projects from initiation through commercialization.
• Manage weekly task execution, project controls, and KPI tracking to ensure projects meet scope, schedule, and budget.
• Spearhead cross-functional teams spanning manufacturing engineering, assay development, consumable and hardware design engineering, manufacturing, facilities, quality, supply chain, and service.
• Oversee project readiness for design transfer to manufacturing, managing the DMR, ensuring BOM accuracy, procedure readiness, and production documentation is complete.
• Collaborate with manufacturing engineering and operations to develop manufacturing processes, establish production activities and material flow, implement equipment and tooling, and validate manufacturing processes in line with cGMP and ISO 13485 requirements.
• Scope work, identify dependencies, and escalate budget or resource constraints promptly.
• Establish dashboards and standard work processes for project management, monitoring and reporting.
• Maintain close control of project deliverables through regular project meetings, dashboards and ad hoc standup meetings.
• Work with project teams to apply Lean and Six Sigma principles into the development activities.
• Ensure project visibility with clear reporting to leadership and stakeholders.
• Develop and maintain detailed project schedules, dashboards, issue logs, and decision registers.
• Create and execute risk management plans, monitoring risks throughout and implementing contingency actions when necessary.
• Drive process improvement initiatives within the project execution framework to enhance efficiency and repeatability for future facility stand-ups.
• Coordinate with suppliers, contractors, and external partners to ensure equipment commissioning, validation, and readiness for product build.

Front-End Software Engineer

Systems Engineer

Associate Manufacturing Engineer

Manufacturing Engineer II

Senior Application Engineer, Rust

Project Manager, Manufacturing Operations