Lead and support the engineering team throughout the full software development lifecycle for FDA 510(k) regulated medical device software (SaMD) . * Collaborate with clinicians, regulatory, and ...
Lead and support the engineering team throughout the full software development lifecycle for FDA 510(k) regulated medical device software (SaMD) . * Collaborate with clinicians, regulatory, and ...
Lead and support the engineering team throughout the full software development lifecycle for FDA 510(k) regulated medical device software (SaMD) . * Collaborate with clinicians, regulatory, and ...
Quick apply
Lead and support the engineering team throughout the full software development lifecycle for FDA 510(k) regulated medical device software (SaMD) . * Collaborate with clinicians, regulatory, and ...
As a software engineer on the Apple Watch team, you will be responsible for building extraordinary ... device software. These include: - We collaborate closely with the design team to open up the ...
As a software engineer on the Apple Watch team, you will be responsible for building extraordinary ... device software. These include: - We collaborate closely with the design team to open up the ...
Clinical Engineering Medical Device Security Engineer
$45.26 - $74.67/hr
... Medical Device Security Engineer I, you will play a critical role in safeguarding CommonSpirit ... Experience working with the software development life cycle or project management methodologies
Clinical Engineering Medical Device Security Engineer
$45.26 - $74.67/hr
... Medical Device Security Engineer I, you will play a critical role in safeguarding CommonSpirit ... Experience working with the software development life cycle or project management methodologies
... Medical Device Security Engineer I, you will play a critical role in safeguarding CommonSpirit ... Experience working with the software development life cycle or project management methodologies
... Medical Device Security Engineer I, you will play a critical role in safeguarding CommonSpirit ... Experience working with the software development life cycle or project management methodologies
Clinical Engineering Medical Device Security Engineer
$45.26 - $74.67/hr
... Medical Device Security Engineer I, you will play a critical role in safeguarding CommonSpirit ... Experience working with the software development life cycle or project management methodologies
Clinical Engineering Medical Device Security Engineer
$45.26 - $74.67/hr
... Medical Device Security Engineer I, you will play a critical role in safeguarding CommonSpirit ... Experience working with the software development life cycle or project management methodologies
Director of Software Engineering - Lead 50+ Engineers (Colorado Springs)
Colorado Springs, CO · On-site
$200K/yr
SRAM is seeking a Director of Software Engineering to lead an organization of approximately 50 engineers across mobile app development, cloud services, and device software. This role includes ...
New
Director of Software Engineering - Lead 50+ Engineers (Colorado Springs)
Colorado Springs, CO · On-site
$200K/yr
SRAM is seeking a Director of Software Engineering to lead an organization of approximately 50 engineers across mobile app development, cloud services, and device software. This role includes ...
New
Clinical Engineering Medical Device Security Engineer II
$49.78 - $82.14/hr
... Medical Device Security Engineer II, you will be a key architect of CommonSpirit Health's robust ... Experience working with the software development life cycle or project management methodologies ...
Clinical Engineering Medical Device Security Engineer II
$49.78 - $82.14/hr
... Medical Device Security Engineer II, you will be a key architect of CommonSpirit Health's robust ... Experience working with the software development life cycle or project management methodologies ...
... Medical Device Security Engineer II, you will be a key architect of CommonSpirit Health's robust ... Experience working with the software development life cycle or project management methodologies ...
... Medical Device Security Engineer II, you will be a key architect of CommonSpirit Health's robust ... Experience working with the software development life cycle or project management methodologies ...
Lead and mentor a two-pizza team of 8-12 Software Development Engineers focused on infrastructure provisioning and device lifecycle * Conduct regular 1:1s, deliver continuous feedback, and drive ...
Lead and mentor a two-pizza team of 8-12 Software Development Engineers focused on infrastructure provisioning and device lifecycle * Conduct regular 1:1s, deliver continuous feedback, and drive ...
Software Development Manager, Device Engagament Metrics
Denver, CO · On-site
$127K - $167K/yr
Lead and mentor a two-pizza team of 8-12 Software Development Engineers focused on infrastructure provisioning and device lifecycle * Conduct regular 1:1s, deliver continuous feedback, and drive ...
Software Development Manager, Device Engagament Metrics
Denver, CO · On-site
$127K - $167K/yr
Lead and mentor a two-pizza team of 8-12 Software Development Engineers focused on infrastructure provisioning and device lifecycle * Conduct regular 1:1s, deliver continuous feedback, and drive ...
Software Development Manager, Device Engagament Metrics
Denver, CO · On-site
$127K - $167K/yr
Recruit, hire, and onboard top engineering talent in alignment with organizational growth goals ... Amazon also offers comprehensive benefits including health insurance (medical, dental, vision ...
Software Development Manager, Device Engagament Metrics
Denver, CO · On-site
$127K - $167K/yr
Recruit, hire, and onboard top engineering talent in alignment with organizational growth goals ... Amazon also offers comprehensive benefits including health insurance (medical, dental, vision ...
Software Engineer, Watch Software
$142K - $263K/yr
... device software. These include: - We collaborate closely with the design team to open up the ... Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and ...
Software Engineer, Watch Software
$142K - $263K/yr
... device software. These include: - We collaborate closely with the design team to open up the ... Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and ...
Software Engineer, Watch Software
$142K - $263K/yr
... device software. These include: - We collaborate closely with the design team to open up the ... Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and ...
Software Engineer, Watch Software
$142K - $263K/yr
... device software. These include: - We collaborate closely with the design team to open up the ... Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and ...
Software Engineer, Watch Software
$142K - $263K/yr
... device software. These include: - We collaborate closely with the design team to open up the ... Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and ...
Software Engineer, Watch Software
$142K - $263K/yr
... device software. These include: - We collaborate closely with the design team to open up the ... Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and ...
Software Engineer II
Lafayette, CO · On-site
$101K - $139K/yr
The Software Engineer II will be responsible for maintaining existing software medical products ... Preferred : • Experience in medical device industry (or other regulated industry) • Experience ...
Software Engineer II
Lafayette, CO · On-site
$101K - $139K/yr
The Software Engineer II will be responsible for maintaining existing software medical products ... Preferred : • Experience in medical device industry (or other regulated industry) • Experience ...
Software Engineer Internships
Denver, CO · On-site
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2025 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Software Engineer Internships
Denver, CO · On-site
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2025 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2025 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2025 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2025 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2025 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Software Engineer Internships
Greeley, CO · On-site
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2025 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Software Engineer Internships
Greeley, CO · On-site
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2025 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Medical Device Software Engineer information
See Colorado salary details
$66.8K - $80.3K
2% of jobs
$80.3K - $93.9K
4% of jobs
$93.9K - $107.5K
6% of jobs
$107.5K - $121.1K
8% of jobs
$128.3K is the 25th percentile. Wages below this are outliers.
$121.1K - $134.6K
7% of jobs
$134.6K - $148.2K
18% of jobs
The median wage is $151.4K / yr.
$148.2K - $161.8K
16% of jobs
$161.8K - $175.4K
2% of jobs
$180.9K is the 75th percentile. Wages above this are outliers.
$175.4K - $188.9K
26% of jobs
$188.9K - $202.5K
1% of jobs
$202.5K - $216.1K
8% of jobs
$66.8K
$155.1K
$216.1K
How much do medical device software engineer jobs pay per year?
What are the key skills and qualifications needed to thrive in the Medical Device Software Engineer position, and why are they important?
To thrive as a Medical Device Software Engineer, you need a solid background in software development, embedded systems, and biomedical engineering, often supported by a degree in computer science, electrical engineering, or a related field. Experience with programming languages like C/C++, knowledge of real-time operating systems, and familiarity with medical device regulatory standards such as IEC 62304 are typically required. Strong problem-solving skills, attention to detail, and effective communication are essential soft skills for this position. These skills ensure high-quality, compliant software that contributes to safe and reliable medical devices, which are critical for patient health.
What is a Medical Device Software Engineer job?
A Medical Device Software Engineer is responsible for designing, developing, testing, and maintaining software used in medical devices. They ensure compliance with regulatory standards like FDA and IEC 62304 while working on embedded systems, user interfaces, or cloud-based healthcare applications. Their role involves collaborating with cross-functional teams, including hardware engineers and regulatory specialists, to ensure patient safety and product effectiveness.
What are some typical daily responsibilities of a Medical Device Software Engineer?
Medical Device Software Engineers typically spend their days designing, coding, and testing software for medical devices in compliance with health regulations. They collaborate closely with hardware engineers, quality assurance teams, and regulatory specialists to ensure that the software integrates seamlessly with device hardware and meets performance and safety standards. Documenting development processes, participating in code reviews, and addressing feedback from cross-functional teams are also common aspects of the role. This position often requires troubleshooting issues in both simulated and real clinical environments to ensure the reliability and safety of the device.
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Full-time
Posted 20 days ago
Job description
We're Cleerly - a healthcare company that's revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world's leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location.
Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly's solutions are supported by more than a decade of performing some of the world's largest clinical trials to identify important findings beyond symptoms that increase a person's risk of heart attacks.
At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description.
While we are mostly a remote company, travel is required for some team meetings and cross function projects typically once per month or once per quarter, for some roles like sales or external facing roles travel could be up to 90% of the time.
Cleerly is committed to providing safe and effective medical software that meets customer needs and our intended use. The adherence to all applicable regulatory and statutory requirements establishes a clear framework for setting measurable quality objectives. Our commitment to continually improving our products and processes proactively manages risks, ensuring ongoing compliance throughout the entire software lifecycle. Understanding this role's relevance and importance is critical to achieving Cleerly's quality objectives.
About the Opportunity
Cleerly, Inc. is a technology-based healthcare company whose mission is to create digital care pathways to prevent heart attacks. Cleerly, Inc, in Denver, CO is seeking an Engineering Manager, Software to assist with the development of the next generation healthcare diagnosis system, with cutting-edge technologies.
Job responsibilities and duties include:
- Lead and support the engineering team throughout the full software development lifecycle for FDA 510(k) regulated medical device software (SaMD).
- Collaborate with clinicians, regulatory, and quality teams to ensure software development aligns with IEC 62304, ISO 13485, and other relevant standards.
- Drive decomposition of clinical and regulatory product requirements into actionable technical designs and software features.
- Manage and mentor engineers, fostering expertise in healthcare software, image processing, and cardiac CT workflows.
- Collaborate with AI/ML teams to integrate validated algorithms into the clinical product, ensuring regulatory compliance, performance, and usability.
- Ensure compliance with cybersecurity, HIPAA, and FDA guidance for medical device software.
- Define and contribute to agile practices tailored to regulated environments, including CI/CD with validated pipelines and automated testing under design controls.
- Partner closely with product managers, radiologists, and data scientists to ensure clinical accuracy and usability of solutions.
- Oversee risk management activities, including software hazard analysis and mitigation.
- Participate in cross-functional design reviews, regulatory audits, and technical file preparation.
- Recruit and onboard top engineering talent with experience in healthcare and regulated domains.
Requirements:
- Bachelor's degree in Computer Science, Software Engineering, or related discipline (Master's preferred).
- 8+ years of software engineering experience, including 2+ years in management/leadership roles.
- Demonstrated experience in medical device software development or healthcare technology, ideally with FDA 510(k) submissions or CE marking.
- Strong programming skills in Python, TypeScript/JavaScript, Node.js, React, and SQL/NoSQL databases.
- Experience developing and securing RESTful and GraphQL APIs.
- Familiarity with AWS cloud services and infrastructure-as-code (Terraform, CloudFormation).
- Experience integrating AI/ML algorithms into production healthcare or medical device software, including validation and performance monitoring.
- Deep understanding of medical imaging (DICOM, PACS, cardiac CT) is a strong plus.
- Knowledge of IEC 62304, ISO 14971 (risk management), ISO 13485 (QMS) and other regulatory frameworks.
- Excellent verbal and written communication skills for both technical and clinical audiences.
- Ability to thrive in a fast-paced, startup-like environment while maintaining regulatory discipline.
- Passion for mentoring engineers and advancing clinical innovation in cardiovascular care.
The base salary range for this role varies by location and is aligned to market benchmarks.
- Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
- Final compensation is determined based on location, experience, skills, and internal equity.
This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:
- Base Salary: $190,000 - $219,000
- TTC: $218,000 - $251,000
*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.
Working at Cleerly takes HEART. Discover our Core Values:
- H: Humility- be a servant leader
- E: Excellence- deliver world-changing results
- A: Accountability- do what you say; expect the same from others
- R: Remarkable- inspire & innovate with impact
- T: Teamwork- together we win
Don't meet 100 percent of the qualifications? Apply anyway and help us diversify our candidate pool and workforce. We value experience, whether gained formally or informally on the job or through other experiences. Job duties, activities and responsibilities are subject to change by our company.
OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation.
For more information see our Privacy Policy (https://cleerlyhealth.com/privacy-policy). All official emails will come from @cleerlyhealth.com email accounts.
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