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Manager Medical Device Software Engineer Jobs in Colorado

Alphatec Spine

Software Engineer II, Valence

Louisville, CO · On-site

$95K - $110K/yr

Experience with medical device software a plus * Experience with C++ and Linux strongly preferred * Experience with Agile software development methodologies, Git / Azure DevOps / Jira * Experience in ...

Alphatec Spine

Software Engineer II, Valence

Louisville, CO · On-site

$95K - $110K/yr

Experience with medical device software a plus * Experience with C++ and Linux strongly preferred * Experience with Agile software development methodologies, Git / Azure DevOps / Jira * Experience in ...

Apple

Software Engineer, Watch Software

Boulder, CO · On-site

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 ...

Apex Systems

Sr. Software Engineer

Greenwood Village, CO · On-site

$124K - $163K/yr

Familiarity with mobile device lifecycle management concepts (activation, provisioning, SIM/eSIM ... Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life ...

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Manager Medical Device Software Engineer information

What does a manager medical device software engineer do?

A Manager Medical Device Software Engineer oversees teams that design, develop, and maintain software for medical devices. They ensure that the software complies with regulatory standards, works reliably, and meets the needs of healthcare professionals and patients. In addition to technical leadership, they coordinate with cross-functional teams, manage project timelines, and mentor engineers. Their role is critical in ensuring products are both safe and effective for use in medical settings.

How does a manager medical device software engineer typically collaborate with cross-functional teams during product development?

A Manager Medical Device Software Engineer frequently works alongside teams such as regulatory affairs, quality assurance, hardware engineering, clinical specialists, and marketing. They coordinate software development activities to ensure compliance with industry standards and regulatory requirements, while also aligning software features with clinical and business needs. These managers often lead design reviews, facilitate risk assessments, and ensure effective communication between software engineers and non-technical stakeholders. This collaborative environment is essential for delivering safe, effective, and user-friendly medical devices.

What are the key skills and qualifications needed to thrive as a manager medical device software engineer, and why are they important?

To thrive as a Manager Medical Device Software Engineer, you need expertise in software development, medical device regulations (such as FDA or ISO 13485), and a background in engineering or computer science, often supported by advanced degrees or certifications. Familiarity with tools like version control systems (e.g., Git), embedded systems platforms, and quality management software is essential, along with understanding regulatory documentation processes. Strong leadership, effective communication, and problem-solving abilities distinguish top performers in this role. These skills are crucial for ensuring safe, compliant, and innovative medical device software development while leading teams to deliver high-quality products.

What are the most commonly searched types of Medical Device Software Engineer jobs in Colorado?

The most popular types of Medical Device Software Engineer jobs in Colorado are:

What are popular job titles related to Manager Medical Device Software Engineer jobs in Colorado?

For Manager Medical Device Software Engineer jobs in Colorado, the most frequently searched job titles are:

What job categories do people searching Manager Medical Device Software Engineer jobs in Colorado look for?

The top searched job categories for Manager Medical Device Software Engineer jobs in Colorado are:

Manager Medical Device Software Engineer jobs near you
Infographic showing various Manager Medical Device Software Engineer job openings in Colorado as of August 2026, with employment types broken down into 1% As Needed, 75% Full Time, 19% Part Time, and 5% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution.

Sr. Engineering Manager (Clinical Labs - Clinical Insights)

Cleerly

Denver, CO • On-site, Remote

Full-time

Re-posted 22 days ago

Key responsibilities

  • 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.

  • Manage and mentor engineers, fostering expertise in healthcare software, image processing, and cardiac CT workflows.

Job description

About Cleerly

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. 

#Cleerly