- Efficient collaboration within a team of Software Quality Assurance Engineers.
- Ensuring software system quality across the developmental stages within a rigorously controlled setting for Active Implantable Medical Devices.
- Validating software and firmware requirements, guaranteeing adherence to security and compliance criteria.
- Assisting in all facets of software creation, testing, and validation for Neuromodulation product ranges.
- Participation in developing and executing Design Validation Plans, Protocols, and Reports for comprehensive system-level testing and issue reporting.
- Scrutinizing design, development, and testing operations for Neuromodulation software and firmware.
- Assessment and endorsement of documents connected to user requirements, hazard analysis, security risk assessments, usability, and more.
- Contribution to validation undertakings involving Automated Test Equipment.
- Backing Software-related Corrective and Preventive Action (CAPA) methods.
- Engagement in Design Validation tasks, encompassing the review of diverse design process elements, testing operations, risk management, and regulatory conformity.
- Undergraduate degree in Computer Science, Software/Electrical Engineering, Biomedical Engineering, or an analogous domain.
- Over 2 years of relevant professional involvement.
- Robust comprehension of testing frameworks and approaches.
- Proficiency in manual system-level testing within a regulated environment.
- Familiarity with Software Development Life Cycle (SDLC) practices following IEC 62304 standards.
- Competence in various programming languages (C#, C++, Swift, Node.js, Java/JavaScript, etc.).
- Postgraduate degree in Computer Science, Software/Electrical Engineering, or a correlated field.
- Superb communication (oral and written) and organizational proficiencies.
- Strong teamwork skills coupled with a constructive mindset. Ability to handle multiple tasks efficiently and collaborate productively with different departments (R&D, Marketing, Manufacturing, Quality & Regulatory, Clinical, Project Management, etc.).
- Precise and detail-focused with a dedication to excellence.
- Experience in the medical device sector or a closely regulated context (desirable).
- Basic grasp of Neuromodulation principles.
- Understanding of CAPA, Complaint Handling, and External Audits (desirable).
- Proficient in Risk Management guidelines as per ISO 14971 (desirable).
- Familiarity with Premarket Cybersecurity Guidance, Post Market Cybersecurity Guidance, and 81001-5-1 standards (desirable).
- Knowledge of Bluetooth technology (desirable).
- Background in mobile application development (desirable).
- Awareness of HIPAA and GDPR compliance protocols (desirable).
- ASQ Certified Quality Engineer (CQE) or ASQ Certified Software Quality Engineer (CSQE) certification (desirable).
Software Quality Assurance Engineer - California, United States - BioTalent
Description
Company Culture
Our client promotes a diverse, forward-thinking, and team-oriented work environment. As a prominent player in the Medical Device sector, you'll be part of impactful projects alongside top-tier teams. Continuous support, access to cutting-edge tools, and ongoing training are all designed to propel your professional growth.
About the Position
This hybrid role is located in Valencia, CA, with an anticipated presence of 3 days per week at the office. Joining a group of skilled professionals, you'll function as a Software Quality Assurance Engineer II, pivotal in enhancing Neuromodulation Software/Firmware products. Your duties will cover the entire product life cycle, from conception to release and beyond.
Leadership in Neuromodulation Technology
Our client specializes in developing implantable medical devices that aid patients in coping with chronic pain and neurological ailments. In this capacity, your contributions will be instrumental to this vital mission.
Main Responsibilities
Requirements
Preferred Qualifications