Manufacturing Process Engineer
In this role, you have the opportunity to manage the manufacturing of Philips AED products. Within this role, you will have end-to-end responsibility for a production line, which included part delivery, manufacturing and test flows and packaging. You will implement and validate the changes required to meet maintain compliance with Internal documents and regulated industry requirements.
You are responsible for
• Responsible for creating the code for the templates necessary to run the paperless factory.
• Responsible for defining and implementing Manufacturing processes for new products and managing the changes for exiting products.
• Responsible for defining, selecting, and validating Manufacturing equipment.
• Fundamental understanding of Lean Manufacturing Principals
• Ability to generate process flow maps and utilize results to improve processes and manufacturing operations.
• Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacturing.
• Lead teams in performing and updating Process FMECA risk management.
• Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities.
• Ensure that all appropriate documentation, drawings specifications are generates in compliance with Philips procedures and regulatory requirements (US FDA and ISO).
• Knowledge of IQ, OQ, PQ Validation Strategies is highly desirable.
You are a part of You are a part of a team consisting of Manufacturing Process Engineers, Manufacturing Life Cycle Engineers, and Manufacturing Test Engineers. Your team will be responsible for Automated External Defibrillators (AEDs) production lines, and will implement and validate the changes required to meet and maintain compliance with internal standards in a regulated Medical Device industry.
To succeed in this role, you should have the following skills and experience
• B.S. in an Engineering discipline or Technical field is highly desired.
• Prefer 1-3 years’ experience
• Basic understanding of software coding in any standard language.
• Microsoft Office applications, including PowerPoint and Project
• Statistics, including SPC and DOE is highly desirable
• Experience with process and equipment validations is highly desirable
• Knowledge of GMP ISO-14971, and ISO-13485 is highly desirable
• Experience with FDA-regulated medical device manufacturing helpful
• Good technical writing ability
In return, we offer you a dynamic working environment in an innovative business, which offers you excellent opportunities to further develop and fully exploit your talents. This job comes with a competitive salary, excellent benefits and up-to-date training.
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.
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.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 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.