€ 50,000 - € 70,000
Detachering via YER
Medical & Health
Over deze vacature
You will hold the Quality Engineering role in a New Business Development venture in the cardio-vascular field. Philips has a strong and unique position in this field through its interventional X-ray, cardiovascular devices and ultrasound portfolio. We are developing a new image-guidance solution based on a revolutionary navigation technology, encompassing a combination of medical consumable devices and imaging equipment. Your challenge is to ensure that these new solutions and ways of working meet the quality requirements to help to make the product a commercial success for Philips.
- 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;
- Act as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone.
With a growing presence in cardiology, oncology, and women's health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor's office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare's unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision making.
Image Guided Therapy (IGT) is a new business group within Philips, spanning the interventional X-ray business, the recently acquired Volcano business and the Business Incubation group. The overall purpose of IGT is to create a clinical solutions business, changing the way Philips interacts with our customers and portfolio. The Business Incubation group (BI) is a dedicated corporate venturing organization tasked to create new solutions for IGT, focusing on procedure innovation and new business model development in the cardio-vascular domain. Within BI, entrepreneurial multidisciplinary teams act as start-ups (ventures) in the larger corporation, tasked to build new businesses and acquire new skills whilst leveraging the competencies of the broader Philips organization. The Quality Engineer BI venture will report to the Head of Quality & Regulatory of IGT BI, who is part of the IGT BI management team.
We welcome you to a challenging, innovative environment with great opportunities for you to explore. YER is preferred supplier. You will be employed by YER and seconded to Philips.
Our benefits are very competitive and designed around your preferences:
- A competitive salary depending on experience
- Extensive set of tools to drive your career, such as a personal development budget, training and coaching
- Healthy work-life balance
We are looking for:
- Rich experience in the field of design transfer and post-market quality assurance;
- Preferable experience on reliability engineering;
- Innovative mindset & entrepreneurial spirit, hands-on approach;
- Passionate personality with outstanding communication and interpersonal skills;
- Academic degree or comparable working experience, excellent analytical and conceptual skills.
- Experience in design transfer & post market quality assurance;
- Ability / willingness to travel when needed abroad;
- Experience in a medical device and or healthcare environment;
- Experience with strict regulations, preferably FDA, ISO 13485;
- Preferably reliability engineer experience.