In this role, you have the opportunity to
In this role, you will support post market activities and other quality tasks for the Sleep & Respiratory Care business unit with primary responsibilities in ensuring compliance in a fast-paced, changing global regulatory environment. The role includes development of strategies to act proactively where appropriate and reactively where necessary based on product performance in the field. The Senior Engineer interfaces with all elements of the quality management system, Sleep & Respiratory Care business, global Philips businesses and markets, regulators, and notified bodies.
You are responsible for
Team with a variety of roles such as Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers, and Manufacturing personnel to facilitate post market surveillance processes globally
Provide primary quality engineering support for global post market surveillance processes including complaint handling, vigilance reporting, field action, and post market surveillance planning activities
Drive technical product investigations in support of field complaints, regulatory agency inquiries, CAPA, service actions, or other objectives and translate results for use in the quality management system.
Consistently apply established device Risk Management File (RMF) decisions to investigations for both individual device failures and systemic failure modes. Identify and escalate issues not represented in established RMF.
Ensure continued alignment of RMF with strategy for global vigilance reporting
Coordinate development of strategy and implementation of field actions including risk assessment and plans for global vigilance reporting
Drive execution of field actions on a global scale with responsibility to identify, assess, and overcome barriers to correction, keep current records, provide periodic status updates, and close field actions
Team with Design Quality Engineering to ensure post market surveillance process capability is established for new product introductions
Evaluate and apply regulatory guidance and changes to post market surveillance processes to ensure continued regulatory compliance
Create responses to regulatory and customer inquiries
Develop, implement, execute, and maintain post market surveillance plans for all products in partnership with Design Quality Engineering and Clinical Affairs
Provide support to Corrective and Preventive Action (CAPA) device investigations and corrections.
Support the internal audit program and participate in preparation and execution of internal and external audits of the local quality management system
Enable a culture of continuous improvement by identifying individual opportunities for improvement and delivering results using LEAN concepts
Lead continuous improvement projects driving cost savings and efficiency gains
Develop and share best practices locally and with other Philips business partners
You are a part of
The post-market surveillance team is responsible for monitoring, investigating, tracking and reporting on the performance of all Sleep & Respiratory Care products in the field. This activity is undertaken primarily through the management of the Complaint Handling System. The team is responsible for global vigilance reporting of individual events, field actions, communications with regulatory authorities and notified bodies, and creating the data required to make key decisions at the executive level to drive business critical decisions.
To succeed in this role, you should have the following skills and experience
Bachelor of Science in an engineering or applied science discipline
Minimum of 5 years' experience in the medical device or other regulated industry
Demonstrated understanding of quality management system elements and interactions
Experience with process improvement, six-sigma, lean manufacturing, or equivalent
Experience with statistical analysis concepts and techniques
Demonstrated success in project management, teaming and influencing others to achieve results
Familiarity in quality complaint handling, vigilance reporting, field action, risk management, and detailed product investigation
Applied knowledge and understanding of global medical device regulations
Experience working with electromechanical devices; medical devices supporting respiratory and pulmonary clinical applications
Experience teaming and interacting on a global scale
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
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 improving 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech/philips-recruitment-process.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation 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.