Verification and Validation Engineer 3
Great innovations start with the people that are passionate and skilled enough to create them. As a diversified health and well-being company, Philips focuses on improving people’s lives through those timely and meaningful innovations.
• Analyzing product and sub-system requirements early in the product design process to ensure SMART requirements.
• Analyze industry standards to ensure product requirements keep the products in compliance. (e.g. 60601, 61010, etc.)
• Writing detailed test procedures that evaluate medical devices and systems against documented mechanical, electrical and software requirements.
• Create trace matrices that show complete risk mitigation and product requirement coverage.
• Conducting large-scale usability studies to ensure the customer’s needs are met
• Instrumentation and test of pneumatic circuits, electrical signals, sound and various physical/environmental characteristics.
• Conducting statistical analysis of test results.
• Maintaining and controlling test execution records using good lab practices.
• Technical writing, including development of test reports.
• Support Domestic/International product registrations by providing proper test result documentation
• Provide design control audit support during internal and regulated body audits, as necessary
Philips Children's Medical Ventures New Product Development organization is responsible for full product lifecycle management of medical devices utilized in the care of neonates and infants. The team designs and develops novel products and services to enable caregivers to provide the best care to newborn's and their families.
Our 2013 Commitment outlines what we are committed to do in the coming year to continue on our journey to become a global leader in health and well-being.
Each and every plan in our business — country, sector, business-unit, or function — must to be driven by, and linked to, our group level 2013 Commitment.
We all have an important role to play in shaping a more successful future for our company. This is an exciting time to be a part of Philips as we will accelerate our journey and become an even stronger Company for you, our employees, and the customers we serve.
We are looking for
• BS in Electrical Engineering, Computer Science or other related disipline required.
• Experience in development of technical user documentation required.
• Minimum of 3 years of related experience,required.
• 1-3 years programming in C# or Visual Basic, or similar-preferred.
• Experience with automated User interface testing-preferred.
• Experience withSoftware testing at various levels.
• Experience with Software development process using ISO 62304 or equivalent.
• Risk Management using IEC 14971 and IEC 60601.
• Systems engineering and testing of mechanical systems.
• Disciplined, regulated industries, medical device experience preferred, including FDA’s 21 CFR 820/ISO 13485 experience.
• ASQ certification, preferred.
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Philips Global - 30+ days ago