Systems Engineer Norm Compliance

New York, New York, United States

Description

Job Description

As a System Engineer Norm Compliance, you will ensure our products meet medical standards by managing life cycle activities, investigating complaints, and conducting post-market surveillance.

Your role:

You are part of the Systems Engineering group in MR R&D

You will work with colleagues around the globe, especially in India, US and China

Support life cycle management, complaint investigations and post-market surveillance activities related to applicable medical standards/regulations

Provide a deep understanding of IEC60601-1 series of medical standards and its translation into requirements, design, and implementation

Support regulatory activities to comply with applicable medical standards/regulations.

Create Test Report Forms (TRF) with proof of compliance to clauses of the applicable standards

Support the certification process. Contribute to managing the certification bodies. Contribute to quality and process improvements in this area

Drive, manage, and contribute to improvement activities in the generation of Test Report Forms

Drive improvements in design in relation to the applicable medical standards/regulations

From a competitive salary to flexible working, a career at Philips comes with all sorts of wonderful benefits. Be sure to speak to your recruiter about benefits in your region.

You're the right fit if you have:

Bachelor's / master's degree in electrical engineering, Electronic Engineering, Mechanical Engineering, Computer Science Engineering or equivalent

5+ years of working experience in relevant areas such as systems engineering, research, development and/or test and verification

Experience with complex, high-tech systems

Experience in the medical device industry. Experience and knowledge of MRI systems will be considered a plus.

Experience in the interpretation and implementation of medical standards in high-tech systems in a global environment

Experience working directly with healthcare regulatory bodies and reporting to competent authorities on compliance with medical standards

Experience in risk management of processes and implementations in a healthcare environment

Experience in arranging a test program with testing laboratories in the medical device industry is a plus

Strong analytical and accuracy skills, quality mindset with a continuous drive to improve

Good communication skills and ability to collaborate in a cross-functional team and experience in creating alignment between broad varieties of stakeholders (internal and external).

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This role is an office role.

*This role is not open to a relocation.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.

• Learn more about our business.

• Discover our rich and exciting history.

• Learn more about our purpose.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

Company

Philips

Royal Philips of the Netherlands is a diversified technology company, focused on improving people’s lives through meaningful innovation in the areas of Healthcare, Consumer Lifestyle and Lighting. The company is a leader in cardiac care, acute care and home healthcare, energy efficient lighting solutions and new lighting applications, as well as male shaving and grooming and oral healthcare.

Since the introduction of the first Philips light bulb more than 120 years ago, innovation and a people-centric approach have always been at the core of our company.

Our commitment is to deliver new healthcare and lighting technologies, as well as innovative and locally relevant consumer products that make a real difference to our customers, consumers and stakeholders across the globe. We believe that the best way for us to do this, is through deep understanding of people’s needs and desires.

When we bring the two together – people and innovation – we create the next generation of technology and things that people truly want and need. These are meaningful innovations that help people to be healthy, live well and enjoy life. This sets us apart and makes us Philips.

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