Senior Software Quality Engineer

2 months ago

Carlsbad, United States Bolt Medical Full time

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS: DO NOT CONTACT.


Position overview: The Software Quality Engineer is responsible for leading 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. The software engineer is responsible for participating in and contributing to the architecture, design and development of the system software, algorithms, and to ensure software development process is compliant with applicable standards, regulations and guidance documents for medical devices and GxP computerized system.


Essential duties and responsibilities:

  • Lead design control and software development for medical devices, ensuring compliance with FDA and EU regulations.
  • Support risk management activities in line with ISO14971 and IEC 62304 standards.
  • Collaborate with various teams (software, hardware, UX, marketing, manufacturing, QA) to generate, document, verify, and validate requirements.
  • Support and optimize design control and software development processes.
  • Guide the creation, review, and approval of design control documents, focusing on software development.
  • Support software tools and computerized systems validation used in production and quality processes.
  • Participate in software development activities, including design and code reviews, requirements analysis, defect tracking, and configuration management.
  • Ensure compliance to IEC 62304, FDA, and EU Guidance on Software Contained in a 510(k) or EU MDR/IVDR submissions
  • Maintain effective risk management using feedback from various sources (validation, field service, post-market surveillance, etc.).
  • Support the creation and review of medical device software documentation, including cybersecurity assessments.
  • Ensure products comply with company procedures and global standards.
  • Support inspection and testing in design and manufacturing.
  • Assist with downstream processes like field service procedures and product returns.
  • Review Design History Files and Technical Files for compliance.
  • Support internal and supplier audits, NCR, and CAPA programs.
  • Perform other duties as assigned.


Required Education/Training and experience:

  • Bachelor’s degree in Electrical, Computer/Software, or Biomedical Engineering.
  • Minimum of 7 years of experience in software quality engineering in a regulated environment.
  • Preferred: ASQ-CSQE certification.
  • Knowledge of FDA software guidance, ISO TR-80001, IEC 62304, and medical device standards.
  • Experience with software development lifecycle methodologies and new product development.
  • Strong analytical, problem-solving, and communication skills.
  • Ability to work in a team and manage priorities in a fast-paced environment.
  • Preferred: Knowledge of IEC 60601 medical device safety standards.


Knowledge, Skills, and Abilities:

  • Experience with medical device software development
  • Experience in Non-Product Software Validation, IQ OQ PQ
  • Experience with a risk-based approach to validate computerized systems
  • Detail oriented and organized
  • Skilled in written and verbal communication
  • Highly responsive
  • Ability to work in a team environment
  • Highly motivated hands-on engineer with a proven record of meeting timelines and goals
  • Must possess strong analytical & problem-solving skills
  • Ability to manage priorities and meet deadlines in a fast-paced environment
  • Must have strong analytical reasoning
  • Must have problem solving capabilities.
  • Self-driven individual who is capable and excited to learn about new technologies.

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