Job Description

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.

In this role, you have the opportunity to make life better

Lead on setting Quality and Reliability targets for IGT Systems medical software products so that these innovative products deliver high quality and outstanding reliability to the lives they will improve. Next to setting targets, you use your expert Quality and Reliability engineering skills to provide coaching and support to the organization and assure that those targets are achieved. This involves being a confident advisor on quality and reliability engineering topics.

You are responsible for
 

Ensure that appropriate SW Quality plans are designed that include all stages of the software lifecycle.
Validate key product design inputs like useability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy serviceability, sustainability and costs.
Provide effective oversight over the execution of the SW Quality Plan; which includes risk management activities and all design related activities during the software lifecycle.
Ensure software design quality and reliability targets are met for every project milestone.
Leading software quality related problem solving.
Using post-market data analysis to report on software performance in the market (provide feedback to manufacturing, suppliers or design teams) and initiate field actions when required.
Act as a single point of contact (person assigned to) for project team(s);
Make substantial contribution to ways of working of combining Agile with medical software development.
 

You are a part of

You will be part of the global Philips Q&R organization and will be reporting within the Design Quality team for IGT-Systems. As member of this team, you contribute to our constant strive for further product quality improvements, so we continuously exceed both internal and external stakeholder expectations. 

To succeed in this role, you should have the following skills and experience

We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life for the billions of people Philips brand touches each year.
 

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

Bachelor’s engineering degree with 8+ years of experience / Master’s degree with 5 years of experience; preferably in Software- or Reliability Engineering role in the medical or aerospace industry.
Ability to define detailed SW Quality and Reliability plans for new SW product development to ensure SW products are Safe, Effective and Reliable. 
Ability to perform SW Risk Management and SW Design FMEAs with teams on all new products and recommend design changes to improve product safety and product quality; and subsequent assurance that control measures are translated in appropriate (critical) requirements.
Strong exposure to application of Design Controls; ability to do thorough Design Reviews during new product development to ensure robustness of SW product design.
Ability to partner with V&V teams to assure thorough SW Verification, Validation and Useability testing.   
Analyze development and field data for trends of Product Safety, Quality and Reliability performances and areas for further improvements of Product design and related development processes.
Ability to conduct reliability analysis to assess the risks associated with design concepts.
Perform statistical data analysis, regression modeling, reliability growth assessment and reliability prediction.  
Experience with adequate and accurate review of DHF and DMR documents.
Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, IEC 62366, IEC 62304 and ISO 14971.
Certified DfSS greenbelt or blackbelt.
Experience with working in multidisciplinary teams in a high tech R&D environment.
Effective interpersonal, written and oral communication skills expected.
Ability and willingness to work at least 3 days in office.