Job Description

Senior Software Quality Engineer

Burlingame, CA

POSITION SUMMARY:

Our cleint is a rapidly growing medical robotics company. As a Software Quality Engineer, you will play a pivotal role in ensuring the quality and compliance of software systems used in complex medical devices. You will be responsible for implementing and maintaining software quality processes in accordance with industry standards, with a primary focus on IEC 62304 and product software verification and validation.

The ideal candidate will act with passion and intensity in a medical device start-up that is fast-paced and collaborative and will display the ability to perform to the requirements outlined below. For the right person, this position will be a tremendously exciting and career-defining opportunity, making core contributions to a genuinely new type of medical robotic platform.

ROLES AND RESPONSIBILITIES:

Software Quality:

• Work closely with the product development team to develop software requirements and manage the quality of software used in a complex electromechanical robotic system.
• Develop and implement software quality plans, procedures, and policies to ensure adherence to quality standards.
• Conduct internal audits and assessments to identify areas for improvement and ensure compliance with QMS as relates to the area of software quality.
• Provide CAPA and audit support in the area of software quality.

Verification and Validation:

• Plan, execute, and oversee software verification and validation activities, including test strategy development, test case creation, and test execution for product software and non-product software.
• Analyze test results and provide recommendations for corrective actions to ensure software meets specified requirements and quality standards.

Risk Management:

• Participate in risk management activities related to software development, including hazard analysis, risk assessment, and risk mitigation planning per ISO 14971.
• Collaborate with cross-functional teams to identify and address software-related risks throughout the product lifecycle.

Documentation and Reporting:

• Prepare and maintain documentation related to software quality activities, including test plans, test reports, and compliance documentation.
• Generate periodic reports on software quality metrics, trends, and compliance status for management review.

Compliance Assurance:

• Ensure compliance with relevant regulations and standards, particularly IEC 62304, throughout the SDLC.
• Review and interpret regulatory requirements related to software quality and provide guidance to the development team.
• Monitor industry trends, best practices, and regulatory updates related to software quality assurance and incorporate them into existing processes.

Continuous Improvement:

• Drive continuous improvement initiatives to enhance software development processes and increase efficiency and effectiveness.

REQUIRED QUALIFICATIONS:

• Bachelor's degree in Computer Science, Software Engineering, or a related field.
• Minimum of 5 years of experience in software quality assurance, preferably in the medical device industry.
• Strong understanding of IEC 62304, ISO 14971, and other relevant standards and regulations governing medical device software.
• Experience with software verification and validation methodologies, including test planning, execution, and reporting.
• Proficiency in risk management techniques and tools, with experience in conducting risk assessments.
• Excellent communication and collaboration skills, with the ability to work effectively in cross-functional teams.
• Attention to detail and strong analytical skills, with the ability to troubleshoot and solve complex problems.

PREFERRED QUALIFICATIONS:

• Advanced degree in Computer Science, Software Engineering, or a related field
• Prior experience in and understanding of systems engineering and robotic controls
• Cybersecurity experience
• Experience with medical device non-product software validation
• Small company or startup experience
• Experience with disposables/consumables
• Experience working with contract manufacturers
• Experience working on roboticized surgical systems
• Certification in software quality assurance or related areas (e.g., ASQ Certified Software Quality Engineer)

Job Tags

Similar Jobs