Mechanical Designer

Job Title Mechanical Designer 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 Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all. In this role, you have the opportunity to In this role, you will have the opportunity to participate in an exciting and progressive environment developing products that save lives. You will be part of the remediation, relaunch, NPI (New Product Introduction) and Sustenance Mechanical Engineering Team within the R&D (Research and Development) Department at Philips SRC (Sleep and Respiratory Care) division. You will be directly involved in the design and development of Ventilators and disposables (masks). You are responsible for For RDD MDR project Lead Sustenance activities for respiratory products, including CAPA child tasks Support ongoing MDD and MDR regulatory compliance Lead and execution remediation tasks Execute any verification activities – as required in the lab for elements and parts Support DHF (design history file) remediation for mechanical engineering deliverables which includes; defining strategy and planning, gap analysis, creating new and revising DHFs, reviewing and releasing DHFs DHF’s accountability and responsibility for mechanical and mechatronic parts and sub systems (Gas path, valves, sensors (air, O2 and Pressure), manifold, patient interface, solenoid valves, filters, blowers, motors and enclosure) Review & mentor - correctness and approve design documentation including requirements specification, design docs, engineering analysis & simulation studies, calculations, capture, test plans, test procedures, test records & reports Lead project team members to produce development plans and identify and mitigate development risks. Conceive, design, develop, evaluate, and implement new systems and products in the field of medical ventilator product development and sustaining engineering. Utilize best practices in mechanical design analysis, modeling, and tolerance analysis to produce a highly viable mechanical. Create documentation, including component details, assembly details, incoming and finished inspection requirements, using CAD (Computer Aided Design) as a design tool. Responsible for all aspects of design documentation including requirements specification, engineering analysis, drawings, test plans/procedures, validation, the release of components, assemblies and products to production, and production start-up support. Supports the manufacturing engineering team in troubleshooting and resolving issues discovered during production. Be a self-starter, action oriented, organized and disciplined. Keep abreast of technical developments in own field through literature, technical contacts, and industry competition. Work in close co-ordination with PMG and manufacturing engineering for resolution of issues as they arise during sample build phases and actual production Lead & or support CAPA activities for closure of CAPA with effective implementation of containment, corrective and preventive actions. Lead RCA investigation for any issues arises in the plant or in the field using fish bone diagrams, probable and potential causes, why-why analysis, replicating issues in the lab and taking containment and corrective actions for re-occurrence prevention. FMEA, RMM and engineering design especially for HW ME elements and parts You are a part of Sleep & Respiratory Care (S&RC) business, a global leader in Sleep & Respiratory, committed to discovering and developing novel solutions to help people sleep & breathe better. Our success spans more than 3 decades and can be attributed to our passion for deeply understanding the needs of the customers we serve and leveraging these insights to develop intuitive, seamlessly connected solutions that lead to healthier patients, healthier practices & healthier businesses. We improve lives by empowering people to breathe easier & to sleep better. By committing to being bold & innovative, challenge convention & collaborating with our customers, we create richer, better solutions to help deliver exceptional & efficient health care. At Philips we are passionate about improving quality of life with solutions designed around the needs of customers and their patients. Innovation is driven by gaining insight to the needs of the people who use our sleep and respiratory solutions. This tradition of innovation, combined with our ability to anticipate market needs, has made Philips a global leader in the markets we serve. To succeed in this role, you’ll need a customer-first attitude and the following Bachelor’s or Master’s degree in Mechanical or Mechatronics Engineering. Minimum of 8 years' experience in the design and analysis of medical devices or similar products Experience in design and analysis of sleep CPAP and BIPAP devices or medical gas delivery systems a plus. Experience leading a technical team in product development. In depth knowledge of pneumatic systems including pressure and flow sensing. Experience in the design and analysis of low and medium pressure gas valves. Experience with low pressure gas blowers. Experience with Computational Fluid Dynamics Experience in the design of plastic injection molded parts. Knowledge of ASME (American Society of Mechanical Engineers) Y14.5 Dimensioning and Tolerancing. Proficiency with solid modeling CAD software (Pro-E/Creo a plus). Good mechanical aptitude and solid understanding of mechanical engineering principles. Effective communication skills, both oral and written. Familiarity with FDA (Food and Drug Administration (USA)) quality systems including ISO13485, 21CFR Part820 (a plus). Familiarity and experience with SAP, Windchill, MBSE tools, CITOL, Ansys WB would be added advantage How we work together We believe that we are better together than apart. This is an office-based role, which means working in-person at least 3 days per week. 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. #connectedcare 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. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success. It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. Know Your Rights