Software Quality Manager

Quality        ·         Herzliya, Tel Aviv, Israel          ·        Full time

Locations: Herzliya, Tel Aviv, Israel

Job ID: 22000HCK

Careers That Change Lives

The Software Quality Manager position will have supervision responsibilities of software quality engineering function throughout the software development lifecycle and during changes of software medical devices. In addition, the position is responsible for advancing best practices in medical device software development, risk management, and product security as well as ensuring that the software development process is followed. This includes identifying and mitigating risks appropriately. This individual will support the development of documentation required for FDA and MDD/ EU-MDR device approval. The individual will work as a principal member of new product development team.

A Day in the Life

• Lead a team Software quality engineers partnering with R&D to deliver world class software that is part of a medical device
• Software Quality assurance of product and development practices during all phases of development to ensure compliance with Medtronic procedures and global regulatory requirements.
• Lead and participate in design, requirements, product security, risk analysis and code reviews (as applicable) and ensure risks are appropriately mitigated.
• Evaluates SW suppliers and third-party developers.
• Track and report on software defects to ensure the resolution of issues found
• Support R&D test automation
• Proficient at analyzing system and software requirements, tracing, testing, and other strategies that maximize test coverage and/or improve system reliability and performance
• Review and approvals of quality system deliverables for submission to regulatory authorities to demonstrate that software developed according to IEC 62304.
• Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.

Must Have:

• BS in Engineering, Computer Science or related field, MS preferred
• A minimum of 3 years in software quality engineering in the medical device field.
• A minimum of 3 years in quality management positions in the medical device field.
• Experience working with an international team.
• Experience with FDA and MDD/ EU-MDR regulations and recommended practices for software.
• Ability to accurately estimate tasks and track/communicate progress
• Experience with requirements management, configuration management and defect tracking tools.
• Excellent verbal and written communication skills
• In-depth knowledge and practical application of ISO 14971, IEC-62304, IEC 62366, 21 CFR 820 & Part 11, ISO 13485 and related standards
• Experience in Agile, change management, and software configuration tools
• Excellent interpersonal, negotiation, and conflict resolution skills
• High level Hebrew and English.

Nice to Have

• Preference – experience releasing medical device software on a regular cadance
• Preference – Knowledge of C/C++ and some familiarity with UML
• Preference – Experience with test automation, especially scripting languages (e.g. Python, Perl, etc.)

We Offer

We offer a competitive salary and benefits package to all our employees:

• Flexible working environment
• Annual Incentive Plan % depending on company results
• Pension scheme and group discount on healthcare insurance
• Training possibilities via Cornerstone/Harvard Manage Monitor/Skills Lab
• Employee Assistance Program and Recognize! (our global recognition program)

About Medtronic

Bold thinking. Bolder actions. We are Medtronic.

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world.

In everything we do, we are engineering the extraordinary.

Travel: Yes, < 25 % of the Time

Please click here to apply.