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Added 2 mins ago
UG
SCA Engineering Tech
UIC Government Services and the Bowhead Family of Companies
Crane, IN
- $36.8 USD / hour
…instructions, equipment requirements, and advice from Supervisor or engineer as needed, performs recurring work…
Added 2 mins ago
Design Engineer
Caterpillar, Inc.
Lafayette, IN
The Large Power Systems Division is currently seeking a Design Engineer to join the G3500 Engine Platform team, located in Lafayette, IN. In this role, you will provide critical support for…
Added 2 mins ago
Electrical Design Engineer
Caterpillar, Inc.
Lafayette, IN
As a Design Engineer with the Large Power Systems Division (LPSD), you will have the opportunity to direct and contribute to the concept, development, and design of complex components,…
Added 3 mins ago
C
Staff Engineer, Firmware & Embedded Software
Carrier
Indianapolis, IN
- $96,000 to $192,000 USD / year
The Staff Engineer is a technical expert responsible for leading the embedded design, development, and optimization of embedded software for our next-generation air-conditioner products.
Added 3 mins ago
Front End Web Applications Developer (Mid-Level) (5664)
SMX
Indianapolis, IN
SMX is currently looking for a highly motivated Software Engineer - Front End Web Applications to contribute to the design, build, support, and implementation of the Budget and Spend (BAS)…
Added 3 mins ago
Front End Web Applications Developer (Junior) (5660)
SMX
Indianapolis, IN
SMX is currently looking for a highly motivated Software Engineer - Front End Web Application s to contribute to the design, build, support, and implementation of the Budget and Spend (BAS)…
Added 3 mins ago
Senior Software Engineer (Institutional, Financing)
Coinbase
Indianapolis, IN
As a Senior Software Engineer on the Financing Engineering team within the Institutional group, you'll design, build, and scale the systems that safely manage billions of dollars in loans…
Added 3 mins ago
Biomedical Engineer
Veterans Affairs, Veterans Health Administration
Indianapolis, IN
Added 3 mins ago
Senior Engineer
PwC
Indianapolis, IN
As a Senior Engineer you will help design, build, and test custom applications within our Advisory practice, bringing together software engineering, cloud-based solution delivery, and…
Added 3 mins ago
Senior Telecom Engineer
Maximus
Indianapolis, IN
Maximus is seeking an experienced Senior Telecom Engineer to lead the design, implementation, and optimization of Genesys Cloud solutions. This role is responsible for executing large-scale…
Added 3 mins ago
LillyDirect Pharmacy Master Data Technical Lead
Lilly
Indianapolis, IN
8+ years of professional experience in data engineering or software engineering, including 3+ years as a tech lead, principal engineer, or senior individual contributor.
Added 3 mins ago
Agentic automation, Frontier AI
Lilly
Indianapolis, IN
You will engineer the connective tissue between Agentic AI and physical lab systems building practical integrations with robotic platforms, analytical instruments, and data pipelines.…
Added 3 mins ago
Lead Engineer
PwC
Indianapolis, IN
As a Lead Engineer you will guide the design, build, testing, and modernization of custom applications across cloud-native and on-premise environments, using modern engineering approaches,…
Added 3 mins ago
Senior Lead Engineer
PwC
Indianapolis, IN
As a Senior Lead Engineer you will lead custom application development and testing efforts that help clients turn business needs into scalable software solutions across cloud-native and…
Added 3 mins ago
Principal CSV Engineer - Automation Engineering
Lilly
Indianapolis, IN · Lebanon, IN
This role will work as a member of the Automation Engineering Department at Eli Lilly, Foundry. The engineer will serve as a technical subject matter expert, providing automation support…
Added 8 mins ago
Associate Engineer, Embedded Firmware
Leviton Manufacturing
Tualatin, OR
This position is responsible for the research, development, and application of software as it relates to new and existing commercial products. As required, this position may encompass the…
Added 9 mins ago
Staff Research Engineer, Expressive Motion and Believability, DeepMind
DeepMind
San Francisco, CA · Mountain View, CA
8 years of experience in software development.
Added 18 mins ago
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Mechanical Design Engineer (HVAC / Plumbing)
GPAC
Union City, CA
- $85,000 to $100,000 USD / year
We are seeking a motivated Mechanical Design Engineer to join an established engineering team in Union City, CA. This position is ideal for someone with a Mechanical Engineering degree and…
Added 19 mins ago
Staff Machine Learning Engineer - Edge AI
Samsara
Remote, United States
…ML infrastructure for Samsara. As a Staff Machine Learning Engineer, you will be working with petabyte-scale sensor, diagnostic, video, and text data to solve critical problems for Physical…
Added 20 mins ago
Senior Engineer
PwC
Birmingham, AL
As a Senior Engineer you will help design, build, and test custom applications within our Advisory practice, bringing together software engineering, cloud-based solution delivery, and…
Added 20 mins ago
Lead Engineer
PwC
Birmingham, AL
As a Lead Engineer you will guide the design, build, testing, and modernization of custom applications across cloud-native and on-premise environments, using modern engineering approaches,…
Added 20 mins ago
Staff Engineer Software Architect - Level 5
Northrop Grumman
Huntsville, AL
…Business Unit (BU) has an exciting career opportunity for a Staff Software Architect Engineer – Level 5 to join our team of qualified, diverse individuals . The position can be located…
Added 20 mins ago
Principal/ Sr Principal Mission Assurance Engineer
Northrop Grumman
Huntsville, AL
Northrop Grumman Defense Systems is seeking a Principal/Sr. Principal Mission Assurance Engineer to support the SLCM-N Program Quality & Mission Assurance Team in Huntsville, AL. This role…
Added 20 mins ago
Senior C/C++ Embedded Software Engineer/Analyst
Intuitive Research and Technology Corporation
Huntsville, AL
We are seeking an experienced C/C++ Embedded Software Engineer who will support the Software and Integration Directorate (S3I) program in the development of launcher control software. In…
Added 20 mins ago
Autonomous Systems Project Engineer- Launched Effects
Integration Innovation, Inc. (i3)
Huntsville, AL
i3 is searching for an Autonomous Systems Project Engineer to serves as the technical innovator and engineering lead driving the development, integration, and flight-testing of…

RapidAI

Senior Quality Engineer

Golden, CO, United States

$95,000 to $115,000 USD / year

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Job details

Pay: $95,000 to $115,000 USD / year
Experience: Experience: 5+ years of software quality engineering experience within the medical device, digital health, or life sciences industry.
Posting language: English
Posted: Nov 4, 2026

Original job description

RapidAI is the trusted leader in deep clinical AI, helping hospitals deliver faster, more informed care through intelligent imaging and integrated workflows. The Rapid Enterprise™ Platform supports disease states across the care spectrum, but it’s our clinical depth that drives the most meaningful impact - improving decision-making, patient outcomes, and health-system performance. Used by more than 2,500 hospitals in over 100 countries and backed by 700+ clinical studies, including research that helped expand national stroke-treatment guidelines, RapidAI is the most clinically validated AI platform in healthcare.

As a Senior Quality Engineer at RapidAI, you will serve as an essential guardian of patient safety, compliance, and product excellence across our industry-leading Software as a Medical Device (SaMD) portfolio. You will embed directly with Engineering, Clinical, and Product teams to ensure our cutting-edge AI diagnostic and workflow solutions meet the highest standards of safety, efficacy, and regulatory compliance from initial concept through global release.

In this role, you will champion robust design controls, lead risk management initiatives, oversee verification and validation (V&V) activities, and continuously refine our Quality Management System (QMS). Working in an agile, AI-first environment, you understand that rapid product iteration must go hand-in-hand with uncompromising regulatory rigor (IEC 62304, ISO 13485, ISO 14971, and FDA QMSR / 21 CFR Part 820).

Work Location:This role requires a hybrid work location arrangement. You will be required and expected to be present and work in the Golden office (1120 Washington Ave, Golden,CO 80401)up to 3 days per week, and as needed for department or functional project meetings. On days when you are not required to be in the office, you will have the flexibility to work remotely, subject to the needs of the team and business. How You Help Us Grow!

Position Duties and Responsibilities:

Lead Software Quality Assurance for SaMD: Establish, implement, and maintain software quality engineering processes across the complete software development life cycle (SDLC) in alignment with IEC 62304, ISO 13485, and FDA regulations.
Design Controls & Requirement Traceability: Review and evaluate software product requirements, architecture specifications, and user stories to ensure complete bidirectional traceability, objective testability, and appropriate risk mitigations.
Risk Management Leadership: Drive product risk analysis in accordance with ISO 14971, ensuring that software hazards, failure modes (dFMEA), and risk controls are systematically identified, mitigated, and verified.
Verification & Validation (V&V) Oversight: Review, audit, and approve software test plans, automated and manual test protocols, V&V execution reports, and clinical evaluation deliverables to guarantee compliance with global regulatory submissions.
Defect & Deviation Management: Oversee and track software problem reports, anomalies, bug escalations, and non-conformances from triage through root cause analysis (RCA), corrective actions, and verified closure.
Test Tool & Automated Infrastructure Validation: Support the development, update, validation, and documentation of internal and third-party software tools utilized in testing and qualifying SaMD (CSV / Software Tool Validation according to ISO/TR 80002-2).
Cross-Functional Quality Partnership: Act as the primary Quality Engineering liaison to R&D, Platform Engineering, Clinical Affairs, and Regulatory, advising teams on design controls without impeding sprint momentum.
Continuous QMS Enhancement: Participate in internal audits, support external regulatory audits (FDA, Notified Bodies/MDR), and drive continuous improvements across our quality management procedures.

What You Bring!

Required Qualifications:

Experience: 5+ years of software quality engineering experience within the medical device, digital health, or life sciences industry.
Education: Bachelor of Science degree in Biomedical Engineering, Computer Science, Software Engineering, Electrical Engineering, or a related technical discipline.
SaMD & Standards Expertise: In-depth, hands-on working knowledge of Software as a Medical Device (SaMD) standards including IEC 62304 (Medical Device Software Life Cycle Processes), ISO 13485, ISO 14971 (Risk Management), and FDA 21 CFR Part 820 / QMSR.
Design Controls & Traceability: Demonstrated track record managing end-to-end design history files (DHF), requirement traceability matrices (RTM), risk documentation, and V&V reports for commercial releases.
Problem Solving & Root Cause Analysis: Proven experience managing software defect lifecycles, CAPA, non-conformances, and driving rigorous root cause investigations with engineering teams.
Communication & Collaboration: Outstanding written and verbal communication skills; ability to hold cross-functional collaborators accountable to strict delivery milestones while maintaining collaborative, trusted relationships.
Results-Driven: Relentless attention to detail with the ability to thrive under tight sprint cycles and shifting priorities in a high-growth environment.

Preferred Qualifications:

Clinical AI & Machine Learning: Experience qualifying or testing AI/ML-based algorithms, computer vision pipelines, or diagnostic decision support software.
Cloud & Agile Environments: Familiarity with modern cloud-native architectures (AWS), CI/CD automated validation pipelines, and Agile/Scrum development methodologies.
Tool Validation: Direct experience with Software Tool Validation (CSV) under ISO/TR 80002-2, including validation of ALM/QMS tools such as Jira, GitHub, Propel, or TestRail.
Regulatory Submissions: Direct experience participating in FDA 510(k), De Novo, or EU MDR technical documentation submissions and external audits.
Certifications: ASQ Certified Software Quality Engineer (CSQE) or Certified Quality Engineer (CQE).

RapidAI is committed to creating an inclusive and diverse workplace. We provide equal employment opportunities to all employees and applicants and prohibit discrimination and harassment of any type in regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Please review our CPRA policies here. For more information on the information we collect about our applicants and how we use it, see our CPRA Privacy Notice here.

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