StaffPrincipal Software Quality Engineer

Campbell, OH - USA

Monthly Salary: $ 150000 - 200000

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Job Summary

Laza Medical a Shifamed Portfolio Company is at the forefront of developing state-of-the-art imaging solutions for cardiovascular applications. Our mission is to democratize top-quality cardiovascular imaging using robotics and AI. To learn more about Laza Medical please visit SHIFAMED

Founded in 2009 by serial entrepreneur Amr Salahieh Shifamed LLC is a privately held medical technology incubator focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.

Description:

The Staff/Principal Quality Engineer will be responsible for driving quality into software product development at Laza Medical. This individual will work proactively with cross functional team members on software development lifecycle processes as applied within the regulated medical device industry.

Responsibilities Skills & Hands-On Experience:

Lead as a quality core team member responsible for driving quality into the design and development of software solutions.
Lead quality focused design and development of software within the software development lifecycle (Agile/Waterfall/DevOps) by defining the requirements design verification and validation plan and strategies while maintaining traceability.
Participate in design reviews for the system as well as review and approve design input/design output artifacts including requirements design documents code review test results verification and validation reports and defects.
Lead and conduct risk management activities including system risk analysis and software FMEAs.
Participate in both internal and external regulatory audits and inspections.
Manage compliance to standards for software quality operating methods processes and procedures (such as ISO 13485 IEC 62304 AAMI TIR 45 Security Standards and Data Privacy).

Education & Work Experience:

Bachelors degree in Engineering Science or Technical Field with a minimum of 8 years of experience in Engineering and/or Quality.
Experience with software quality engineering activities for new product development.
Ability to author technical reports and standard operating procedures.
Exposure to medical imaging solutions leveraging machine learning/ artificial intelligence (AI).
Demonstrated ability to support multiple projects.

Our salary ranges are calculated by role level and location. Please note that your position within that range will be determined by your job-related knowledge location skills experience relevant education and training/certifications. The base salary range for this full-time position is between $150000 - $200000 equity benefits.

NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to

Required Experience:

Staff IC