Sr Software Quality Engineer

Title: Sr Software Quality Engineer

This position is based in our Campbell, California offices. This position is hybrid & 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 provides Quality Assurance support for the 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, supporting the delivery of 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.
• Support the creation, review, and approval of 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, analyzed, mitigated, and documented.
• Support the review of 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.
• Support the preparation and maintenance of 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.
• Support the collection and reporting of software quality metrics to monitor performance and identify opportunities for improvement.
• Support projects in an aggressive manner consistent with corporate objectives.

What You’ll Bring:

• Bachelor’s degree in Software engineering, Computer Science, Biomedical Engineering, or a related Science/Engineering field and a minimum of 5 years of related experience in the medical device or related regulated industry; or equivalent combination of education and work experience.
• Strong knowledge of software development lifecycle processes and standards, including IEC 62304 for medical device software.
• Demonstrated experience with software risk management in alignment with ISO 14971 and cybersecurity requirements for medical devices, including familiarity with FDA cybersecurity guidance.
• Experience reviewing and managing software verification and validation (V&V) deliverables such as test protocols, reports, and traceability matrices.
• Familiarity with integration of cybersecurity principles into software development, including threat modelling, vulnerability analysis, and mitigation plans.
• Experience working with electro-mechanical systems, robotics, or other complex medical devices is a plus.
• Excellent communications skills (both written and verbal)
• Must be able to write clear, concise, and well thought out technical documentation with a focus on element of traceability, external standard or regulations rationale, risk management.
• Must be able to perform multiple tasks concurrently with accuracy.

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: $150,000 to 165,000 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.