Senior Design Quality Engineer

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

• Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design
• Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability, and costs
• Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle
• Performs independent technical assessment on product quality performance and post-market product quality analysis.
• Can Lead quality related problem solving and root cause analysis during design and manufacturing
• Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required.
• Performs independent technical assessment on product quality performance and post-market product quality analysis
• Provide leadership and oversight to ensure Quality Management System Compliance
• Be able to plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement systems
• Ensure the compliance requirements are met during Design review , design verification & Design validation , Design transfer
• Apply and facilitate Design for Quality & Reliability best practices (FMEAs, robust design, V&V, root cause analysis & problem solving)

You are a part of

The Philips Hospital Respiratory Care business group, supporting products including invasive and noninvasive hospital ventilators, patient interfaces, sensors, and monitoring equipment.   We believe that by understanding our customers’ problems we can ease the discomfort of ventilation by providing innovative solutions to improve the patient-ventilator experience, permit speech, and speed liberation. These technological breakthroughs allow the clinician to concentrate more on the patient and less on the device.

To succeed in this role, you’ll need a customer-first attitude and the following

• Bachelor’s Engineering degree with 12+ years of related experience or Master’s degree with 5+ years of related experience -Mechanical/ Electrical/ Electronic or Equivalent Engineering
  • Engineering Degree or equivalent experience in medical device industry
  • 5+ years’ experience with a medical device company preferably
• Can Lead quality related problem solving and root cause analysis during design and manufacturing

• Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards (21 CFR Parts 820, ISO13485, ISO14971, MEDDEV, EU MDR, etc.)
• Experience or understanding of Software or Hardware development, Verification and Validation, Risk management, RCA, Requirements Management, Design, Usability.
  • Have an understanding of Sample Size Determination and Statistical Methods , Safety Risk Management (i.e ISO 14971) and Failure Modes and Effects Analysis (FMEA) / Fault Tree Analysis-.
  • Have understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
  • Have an understanding of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
  • Be able to develop and implement quality programs, including tracking, analyzing, reporting, and problem solving.

In return, we offer you

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long-term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.

How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.

Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.

Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.