Sr. Software Quality Engineer - Medical Devices

Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $12 billion in FY23 and approximately 26,000 people globally working alongside 125,000 global customers, ADI ensures today’s innovators stay Ahead of What’s Possible. Learn more at www.analog.com and on LinkedIn.

Job Summary: We are seeking an experienced Software Quality Engineer to join our dynamic team in the medical device industry. The ideal candidate will have a strong background in computer software validations and a deep understanding of regulatory requirements. This role is critical in ensuring the quality and compliance of our software products, which are integral to the safety and effectiveness of our medical devices.

Key Responsibilities:

• Develop, implement, and maintain software quality assurance processes and procedures.
• Conduct software validation activities in accordance with regulatory standards (e.g., FDA, ISO 13485).
• Collaborate with cross-functional teams to ensure software development and validation activities meet quality and compliance requirements.
• Perform risk assessments and develop mitigation strategies for software-related issues.
• Review and approve software documentation, including validation plans, protocols, and reports.
• Participate in internal and external audits, providing expertise on software validation processes.
• Monitor and analyze software quality metrics to identify trends and areas for improvement.
• Provide training and support to team members on software quality and validation processes.
  
  

Qualifications:

• Bachelor’s degree in Computer Science, Engineering, or a related field.
• Minimum of 10 years of experience in software quality engineering, preferably in the medical device industry.
• Proven experience in computer software validations and familiarity with regulatory requirements (e.g., FDA 21 CFR Part 11, ISO 13485).
• Strong understanding of software development life cycle (SDLC) and quality assurance methodologies.
• Excellent problem-solving skills and attention to detail.
• Strong communication and interpersonal skills.
• Ability to work effectively in a team environment and manage multiple projects simultaneously.
  
  

Preferred Qualifications:

• Advanced degree in a related field.
• Certification in software quality engineering (e.g., ASQ CSQE).
• Experience with automated testing tools and techniques.
• Knowledge of cybersecurity principles as they apply to medical device software.
  
  

For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls. As such, applicants for this position – except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) – may have to go through an export licensing review process.

Analog Devices is an equal opportunity employer. We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group.

EEO is the Law: Notice of Applicant Rights Under the Law.

Job Req Type: Experienced

Required Travel: Yes, 10% of the time

Shift Type: 1st Shift/Days