Software Quality Assurance Engineer
In this role, you have the opportunity to join a fast-growing Philips venture, disrupt a billion dollar industry and touch millions of lives by developing a unique medical device solution. You will have the opportunity to work with a very entrepreneurial venture organization and support the growth of this organization with the right fundaments and will be the quality responsible within the team, with a primary focus on the software design controls and quality assurance.
You are responsible to
Assure and control the hardware and software design quality of EPD products
Work closely with the R&D and Validation & Verification team and review their inputs and outputs including plans, specifications, requirements, drawings, protocols, test reports results and raw data.
Work closely with the HW and SW development teams and review design specifications, requirements, participate in design reviews and be a core-team member representing QA.
Promoting awareness of product, regulatory and customer requirements
Participate and coordinate the risk management process
Participate in design related complaint investigations and failure analysis teams.
You are a part of
Philips EPD Solutions, a recently acquired venture with ambitious plans for growth, developing a disruptive technology, which will improve the efficiency and efficacy of life-saving cardiac ablation procedures treating among others atrial fibrillation. EPD’s technology has the potential to address the key unmet need of real-time therapy assessment, which is one of the more significant limitations of the current standard of care. We aim to help to improve outcomes for millions of people and help maintain the rapidly rising cost of managing the disease. Having obtained CE mark in 2018, we are preparing for a commercial product launch in Europe, US and other territories and are seeking regulatory approvals around the world. You will have many interfaces with the corporate Q&R team in Best Eindhoven and will be based in Caesarea, Israel. You will be reporting into the global Q&R Lead of EPD in the US.
To succeed in this role, you should have the following skills and experience
A Masters or Bachelor Degree in SW, HW, Electrical or other Engineering discipline (or equivalent knowledge). Thorough understanding of HW and Electrical design, Software development/software QA/Development experience working in a medical device business.
Extensive knowledge of Design controls, Software development process (IEC 62304), software validation and verification as well as the software hazard evaluation process (risk management)
Knowledgeable in medical regulations and international regulatory requirements including proficient understanding and knowledge of QMS regulations and activities.
Understanding Python and or C++ coding language is a big advantage
Excellent verbal and written communication skills in English
Excellent organizational skills and ability to execute on multiple priorities in a fast paced environment
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