SW Quality Assurance Engineer

Vectorious has developed the world’s first in-heart microcomputer and is on a mission to transform heart failure treatment. As part of our first in-human clinical study, we have successfully implanted our sensory device in patients across Europe and Israel, while demonstrating a huge potential in helping millions of people living with heart failure to take control and manage their disease. As an increasingly growing company we’ve been accepted to FDA’s prestige Breakthrough Device Designation program.

We are looking for an experienced SW Quality Assurance Engineer to join our QA Team and support our meaningful growth.

What will you do?

• To be Quality expert for SW Development Lifecycle and as such Provide Design Assurance/Quality Engineering support of R&D and V&V teams
• Provide guidance for SW product development under Design Controls and Software Development Lifecycle processes
• Assist with defining and documenting product SW requirements in accordance to internal procedures and quality regulations
• Implement and maintain SW Development process and SW Validation and verification policy and procedures
• Identify the opportunities for continuous improvement of development processes and  product quality and robustness
• Provide guidance and decisions on R&D activities to ensure compliance with internal procedure and regulatory requirements
• Write and review verification and validation protocols and reports
• Be valuable partner in Defect Tracking Management
• Define and implement process control & monitoring of SW projects and development processes

What do you need to bring with you?

• Bachelor’s degree in Electrical/SW Engineering
• 3+ years of experience in SW Design Assurance preferable in Medical Device companies (active implants companies – an advantage)
• Familiarity with international quality regulations –ISO 13485, ISO 14971, ISO 62304, US 21 CFR 820 and other SW Development Guidances for medical device industry
• Ability to partner with R&D and V&V departments and collaborate with various departments within the organization
• Experience in implementing and guide quality standards in day-to-day activity
• Impactful experience in SW validationand risk management tools
• Experience in writing SW validation and verification protocols
• Experience in defect tracking and management
• Technical writing skills
• An ability to successfully communicate and educate QMS regulations, policies and strategies to employees at all levels of the organization