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Senior Software Quality Assurance Engineer

2 months ago

Carlsbad, United States Bolt Medical Full time
Job Description

Bolt Medical is seeking a highly skilled Senior Software Quality Assurance Engineer to lead our Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development projects and for automated data processing systems used as part of the quality system.

Key Responsibilities:
  • Lead Design Control and Software Development: Ensure compliance with FDA and EU regulations for medical devices.
  • Support Risk Management Activities: Collaborate with various teams to generate, document, verify, and validate requirements in line with ISO14971 and IEC 62304 standards.
  • Collaborate with Cross-Functional Teams: Work with software, hardware, UX, marketing, manufacturing, and QA teams to optimize design control and software development processes.
  • Guide Design Control Document Creation: Focus on software development and ensure compliance to IEC 62304, FDA, and EU Guidance on Software Contained in a 510(k) or EU MDR/IVDR submissions.
  • Support Software Tools and Computerized Systems Validation: Ensure compliance to IEC 62304, FDA, and EU Guidance on Software Contained in a 510(k) or EU MDR/IVDR submissions.
  • Participate in Software Development Activities: Design and code reviews, requirements analysis, defect tracking, and configuration management.
  • Maintain Effective Risk Management: Use feedback from various sources, including validation, field service, post-market surveillance, etc.
  • Support Medical Device Software Documentation: Create and review documentation, including cybersecurity assessments.
  • Ensure Product Compliance: Ensure products comply with company procedures and global standards.
  • Support Inspection and Testing: Assist with design and manufacturing inspection and testing.
  • Assist with Downstream Processes: Field service procedures and product returns.
  • Review Design History Files and Technical Files: Ensure compliance to IEC 62304, FDA, and EU Guidance on Software Contained in a 510(k) or EU MDR/IVDR submissions.
  • Support Internal and Supplier Audits: NCR, and CAPA programs.
Requirements:
  • Education: Bachelor's degree in Electrical, Computer/Software, or Biomedical Engineering.
  • Experience: Minimum of 7 years of experience in software quality engineering in a regulated environment.
  • Preferred Qualifications: ASQ-CSQE certification, knowledge of FDA software guidance, ISO TR-80001, IEC 62304, and medical device standards.
  • Skills: Software development lifecycle methodologies, new product development, analytical, problem-solving, and communication skills.
  • Abilities: Ability to work in a team, manage priorities in a fast-paced environment, and highly motivated hands-on engineer with a proven record of meeting timelines and goals.