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Advancing intervention for ischemic stroke.
The Role
The Staff Software Quality Engineer ensures compliance and quality assurance for medical device software, manages quality processes, and reviews documentation and deliverables throughout software lifecycle.
Summary Generated by Built In
Title: Staff Software Quality Engineer
This position is based in our Campbell, California offices. This position is on-site & full-time
Why Telos Health?
At Telos Health, an Imperative Care company, we are developing novel robotic-assisted technologies and interventional capabilities that will forever change the disparate outcomes of ischemic stroke – a disease that impacts close to a million people a year in the U.S., and 10 million worldwide. Not only is Telos changing the way stroke is treated, but also bringing this treatment to the greater population who is currently without. We are actively building a team who is focused on developing novel solutions for this complex disease – a disease in which one in four adults will face in their lifetime.
What You’ll Do
This position contributes to Quality Assurance development and maintenance of Imperative Care (Telos Health)’s medical device software products in alignment with the Company’s Quality Policy and Objectives. The role ensures compliance with applicable standards and regulations, and delivering safe, effective, and high-quality medical device software solutions.
What You’ll Bring:
Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.
Join Us! Apply today.
Salary Range: $160,000 to 177,000 annually
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources.
This position is based in our Campbell, California offices. This position is on-site & full-time
Why Telos Health?
At Telos Health, an Imperative Care company, we are developing novel robotic-assisted technologies and interventional capabilities that will forever change the disparate outcomes of ischemic stroke – a disease that impacts close to a million people a year in the U.S., and 10 million worldwide. Not only is Telos changing the way stroke is treated, but also bringing this treatment to the greater population who is currently without. We are actively building a team who is focused on developing novel solutions for this complex disease – a disease in which one in four adults will face in their lifetime.
What You’ll Do
This position contributes to Quality Assurance development and maintenance of Imperative Care (Telos Health)’s medical device software products in alignment with the Company’s Quality Policy and Objectives. The role ensures compliance with applicable standards and regulations, and delivering safe, effective, and high-quality medical device software solutions.
- Implement and maintain Quality Management System (QMS) processes, procedures, and techniques applicable to software development, verification, and validation.
- Provide quality engineering support throughout all phases of the software development lifecycle, including requirements development, design reviews, risk management, V&V, and design transfer.
- Create, review, and approve software documentation to ensure compliance with internal processes and external standards (e.g., IEC 62304).
- Actively participate in the software risk management process, ensuring risks are appropriately identified, analysed, mitigated, and documented.
- Review software verification and validation (V&V) deliverables, including test protocols, test reports, and traceability matrices, ensuring they meet regulatory and internal quality standards.
- Review cybersecurity documentation, including threat assessments, vulnerability analyses, and mitigation plans, to confirm compliance with applicable standards such as FDA guidance on cybersecurity for medical devices.
- Prepare and maintain the software design history file (DHF) in alignment with FDA and international regulatory requirements.
- Perform document control activities related to software deliverables, ensuring accurate versioning and proper traceability.
- Review design change orders (DCOs) involving software changes to ensure compliance with QMS and regulatory requirements.
- Collect and report software quality metrics to monitor performance and identify opportunities for improvement.
- Support projects with a sense of urgency consistent with corporate objectives.
- May provide quality metric data to various functional groups within the organization.
What You’ll Bring:
- Implement and maintain Quality Management System (QMS) processes, procedures, and techniques applicable to software development, verification, and validation.
- Provide quality engineering support throughout all phases of the software development lifecycle, including requirements development, design reviews, risk management, V&V, and design transfer.
- Create, review, and approve software documentation to ensure compliance with internal processes and external standards (e.g., IEC 62304).
- Actively participate in the software risk management process, ensuring risks are appropriately identified, analysed, mitigated, and documented.
- Review software verification and validation (V&V) deliverables, including test protocols, test reports, and traceability matrices, ensuring they meet regulatory and internal quality standards.
- Review cybersecurity documentation, including threat assessments, vulnerability analyses, and mitigation plans, to confirm compliance with applicable standards such as FDA guidance on cybersecurity for medical devices.
- Prepare and maintain the software design history file (DHF) in alignment with FDA and international regulatory requirements.
- Perform document control activities related to software deliverables, ensuring accurate versioning and proper traceability.
- Review design change orders (DCOs) involving software changes to ensure compliance with QMS and regulatory requirements.
- Collect and report software quality metrics to monitor performance and identify opportunities for improvement.
- Support projects with a sense of urgency consistent with corporate objectives.
- May provide quality metric data to various functional groups within the organization.
Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.
Join Us! Apply today.
Salary Range: $160,000 to 177,000 annually
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources.
Top Skills
Cybersecurity Methodologies
Fda Guidance
Iec 62304
Quality Management System (Qms)
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The Company
What We Do
At Telos Health we’re developing innovative, robotic-assisted technology that’s expected to transform the way ischemic stroke is treated - so that we can transform the way life is lived.
As a subsidiary of Imperative Care, Telos Health is part of a broader purpose-driven organization dedicated to addressing gaps in the health care system from disease detection through patient recovery. Together, Imperative Care companies are reimagining the way stroke and vascular diseases are treated.
