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Remote Medical Device Software Engineer Jobs in California

Tempus

Senior Quality Engineer

Redwood City, CA · On-site +1

Be involved in the medical device software design controls activities, in accordance with the FDA ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...

Stryker

Staff Software Engineer

San Jose, CA · On-site +1

$133K - $222K/yr

Design, develop, modify, and verify medical device software components in accordance with defined ... Remote Procedure Calls (gRPC). Preferred: * Knowledge of Ethernet and IP networking, including ...

Proticom

Knowledge of ISO 9001/13485, FDA 21 CFR Part 820, and medical device software documentation requirements. * Ability to mentor engineers and testers, provide constructive feedback, and elevate team ...

Jj

Software Quality Engineering Lead

Santa Clara, CA · On-site +1

$187K - $207K/yr

Manage Direct Reports and oversees their medical device software projects to ensure compliance to ... Certified Software Quality Engineer (CSQE) certification required. *Project Management Professional ...

Tang and Company

Software Engineer

Torrance, CA · On-site +1

Software Engineer Employment Type Full-Time About the Role We are seeking a talented and motivated ... Ability to work independently in a remote environment while contributing effectively to a ...

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Remote Medical Device Software Engineer information

What are some common challenges faced by Remote Medical Device Software Engineers, and how can they be addressed?

Remote Medical Device Software Engineers often encounter challenges related to stringent regulatory compliance, secure communication, and effective collaboration with cross-functional teams such as QA, hardware engineers, and clinicians. Managing time zones and clear documentation is essential to ensure code quality and traceability, especially since these devices directly impact patient safety. To address these challenges, engineers should prioritize robust version control, frequent virtual check-ins, and proactive communication to align with team goals and regulatory requirements. Leveraging collaboration tools and maintaining detailed documentation can further streamline the development process and facilitate smooth teamwork.

What does a Remote Medical Device Software Engineer do?

A Remote Medical Device Software Engineer designs, develops, tests, and maintains software used in medical devices while working from a remote location. They are responsible for ensuring the software complies with healthcare regulations and safety standards, such as FDA or ISO requirements. Their work often involves collaborating with cross-functional teams, troubleshooting issues, and updating software throughout the product lifecycle. This role requires expertise in both software engineering and medical device regulations.

What are the key skills and qualifications needed to thrive as a Remote Medical Device Software Engineer, and why are they important?

To thrive as a Remote Medical Device Software Engineer, you need strong programming skills (especially in C/C++ or Python), a solid understanding of embedded systems, and a degree in computer science, biomedical engineering, or a related field. Familiarity with medical device standards (such as IEC 62304), version control systems like Git, and experience with software validation and regulatory documentation are typically required. Excellent problem-solving abilities, proactive communication, and strong collaboration skills are vital for working effectively in distributed teams. These skills ensure the development of safe, high-quality software that meets strict regulatory requirements and supports patient health.
What are the most commonly searched types of Medical Device Software Engineer jobs in California? The most popular types of Medical Device Software Engineer jobs in California are:
What are popular job titles related to Remote Medical Device Software Engineer jobs in California? For Remote Medical Device Software Engineer jobs in California, the most frequently searched job titles are:
What job categories do people searching Remote Medical Device Software Engineer jobs in California look for? The top searched job categories for Remote Medical Device Software Engineer jobs in California are:
What cities in California are hiring for Remote Medical Device Software Engineer jobs? Cities in California with the most Remote Medical Device Software Engineer job openings:
Remote Medical Device Software Engineer jobs near you
Senior Quality Engineer

Senior Quality Engineer

Tempus

Redwood City, CA • On-site, Remote

Full-time

Posted 23 days ago

Job description

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

PLEASE NOTE: This is a hybrid role requiring three days a week in the office. Candidates can be based out of our Chicago (Headquarters), New York, or Redwood City locations.

As a Senior Quality Engineer, you will:

  • Lead verification, validation and maintenance of host systems supporting Tempus Medical Device(s).

  • Lead risk assessments to determine testing strategies.

  • Be involved in the medical device software design controls activities, in accordance with the FDA Quality System Regulation, ISO 13485, GAMP5, Computer System Validation (CSV) standards and FDA guidance, other applicable regulatory requirements, as well as best practices in the software industry.

  • Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and computer systems against user, functional and regulatory requirements.

Responsibilities:

  • Support regulatory compliance of the host system operating with Tempus Medical Device(s).

  • Develop and maintain CSV policies, procedures, templates and work instructions.

  • Lead risk-based approach to host / computer system validation (HSV/CSV), SDLC and design controls activities.

  • Perform validation, re-validation and change controls of various AI, SaaS, and Tempus in-house developed software.

  • Author and review software validation deliverables, including Risk Assessments, Validation Plans, Requirements (URS), Validation Protocols (IQ, OQ, PQ), UAT (User Acceptance Test), and Validation Reports.

  • Collaborate with cross-functional teams in developing test-driven system/functional requirements, defining testing strategies and participating in test execution.

  • Support Change Management and Major Incidents (MI) processes, ensuring organizational compliance and continuous improvement.

  • Provide support to Quality and IT organizations in maintaining compliance to various policies, procedures and activities, including support during internal/external inspections and regulatory and customer audits.

  • Provide CSV guidance, coaching, mentorship, and training to test engineers within the team.

Qualifications

  • BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines.

  • 5+ years experience in FDA regulated domain (e.g. medical device, pharma, biotech)

  • 3+ years experience in Computer System Validation (CSV).

  • Experience with industry standards and best practices for Medical device software and CSV such as Design Controls, GAMP 5, FDA 21 CFR Part 11, FDA (QSR) FDA 21 CFR 820.30, Medical device software (QMS) ISO 13485:2016, FDA 21 CFR 820, and Software life cycle processes (IEC 62304:2006).

  • Knowledge of quality system principles, practices, and standards for the life science industry.

  • Ability to deliver quality outputs without directions or under minimal supervision.

Chicago Pay Range: $90,000-$130,00

NYC/SF Pay Range: $100,000-$150,000

The expected salary range above is applicable if the role is performed from California and may vary for other locations (Colorado, Illinois, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.

Additionally,for remote roles open to individuals in unincorporated Los Angeles - including remote roles-Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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