Senior System Engineer - Product Safety & Risk Management

1 Month ago • 5-7 Years • Product Management

Job Summary

Job Description

As a Senior Systems Engineer, you will contribute to the creation and maintenance of high-quality products while meeting user, business, and regulatory requirements. You will provide technical leadership and manage stakeholders effectively. Your role will involve leading teams in product safety risk management, overseeing engineering execution to ensure designs meet quality, safety, and reliability standards, and conducting risk assessments while implementing control measures. The role also includes supporting regulatory submissions, complaint investigations, and post-market surveillance. This position requires understanding of ISO 14971 and experience with document management systems, creating and maintaining documentation.
Must have:
  • Bachelor’s or Master’s degree in relevant field.
  • 5+ years of Quality/Risk Management experience.
  • Experience creating risk management deliverables.
  • Extensive experience in product development.
Good to have:
  • PhD in a relevant field.
  • Experience with audits

Job Details

Job Title

Senior System Engineer - Product Safety & Risk Management

Job Description

As a Senior Systems Engineer you will contribute to the creation and maintenance of high-quality products, meeting user, business and regulatory requirements. You will manage complexity and show technical leadership and effective stakeholder management.

Your role:

  • You will be an expert leading our teams in the domain of product safety risk management
  • You are part of the Systems Engineering group in MR R&D
  • You will oversee the engineering team's execution to ensure designs meet criteria for quality, safety and reliability, while maintaining comprehensive risk management related documentation and advancing system engineering practices
  • You will conduct risk assessments, implement control measures, and support regulatory submissions to align with medical standards and ensure product safety throughout the life cycle, including support of complaint investigations and post-market surveillance
  • You are aware of ISO 14971 and its implications for medical device development and are comfortable communicating and implementing the standard in your work context.
  • You are able to work with industry standard document management systems.
  • You are comfortable using office tooling to create and maintain documentation.
  • 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 hold a Bachelor’s degree in a relevant field* and have a minimum of 7 years of relevant work experience OR a Master’s degree in a relevant field* and a minimum of 5 years of relevant experience. A PhD degree in a relevant field* would be a plus. *relevant fields: safety engineering, mechanical engineering, electrical engineering, physics
  • You hold 5+ years of Quality/Risk Management experience and have experience creating risk management deliverables in a highly regulated industry (preference will be given to the medical device/healthcare industry)
  • Extensive experience in product development and preferrably post-market surveillance in a highly regulated industry (preference will be given to the medical device/healthcare industry)
  • You have a strong drive to maintain state of the art risk management files
  • Experience with audits would be considered a plus
  • You can work independently but also as part of a team
  • You can influence the thinking of, and gain acceptance from, others including stakeholders and take responsibility for timely decisions.

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 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 improve the lives of others. 

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

#LI-EU

#LI-OFFICE

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About The Company

At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.Together, we deliver better care for more people because we believe that every human matters.

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