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Senior Design Quality Engineer

Company: Philips Electronics North America Corporation
Location: Carlsbad
Posted on: September 15, 2021

Job Description:

Job Title

Senior Design Quality Engineer

Job Description

If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request.  You may contact 888-367-7223, option 5, for assistance.

In this role, you have the opportunity to

The Senior Design Quality Engineer will be assigned to R&D and Post Market Surveillance teams supporting the design life cycle and transfer of the products into manufacturing, ensuring compliance with the Quality System Regulations, especially 21 CFR Part  803, 806, 820 and ISO 13485.  

The Senior Design Quality Engineer will provide independent oversight for system, hardware, and software quality during the design input process, design V&V activities, product realization and contribute to complaint closure, FI analysis, Quality Reviews, and CAPA’s. The product focus will be on Gas Sensing Technology Business. 

You are responsible for

  • Ensures appropriate quality and design plans are created that include all stages of the life cycle of the product
  • Performs and completes assigned complaints investigations, including but not limited to Product Failure Analysis and complaint documentation review (DHR, complaints history, products instructions, risk management, etc.) and prepare investigation reports.
  • Work with cross functional groups such as New Product Development and Sustaining Engineering to ensure Quality problems have been identified and contained.
  • Prepare information for Quality Management Reviews and Operational Reviews such as: trend charts, Pareto Analysis, etc., as required on complaint data.
  • Evaluation of complaint information received from clinical environments, such as device failure mode, manufacturing documentation review, labeling and instructions for use review.
  • Support and handling of Corrective and Preventive Actions.
  • Assist the Research and Development department to verify that; modifications to the manufacturing processes and/or product design do not affect product suitability for its intended use.
  • Ensure compliance to EU MDR requirements, particularly Annex I, the General Safety and Performance Requirements, (GSPR).
  • Performs other duties as needed to ensure compliance with relevant FDA QSRs, EU MDR and other ISO regulations.

You are a part of

Philips is one of the world's leading healthcare technology companies. We are committed to understanding the technological and human needs of patients and caregivers and to delivering solutions that enable more confident diagnoses, more efficient delivery of care, and more positive user experiences. People focused. Healthcare simplified.

The Philips Hospital Respiratory Care business products include invasive and noninvasive hospital ventilators, patient interfaces, sensors, and monitoring equipment.   We believe that by understanding our customers’ problems we can ease the discomfort of ventilation by providing innovative solutions to improve the patient-ventilator experience, permit speech, and speed liberation. These technological breakthroughs allow the clinician to concentrate more on the patient and less on the device.

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

  • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
  • B.S. degree in an engineering discipline, Electrical Engineer degree or a related technical field or equivalent is highly desirable. ASQ (CQE, CRE, CQA) Certifications a plus.
  • 5+ years of experience as a Quality/Reliability Engineer, Design Engineer working within the framework of a Quality System.
  • Experience with medical device manufacturing with electronic and/or electromechanical products preferred.
  • Experience with design review processes, CAPA Process, and capable to perform risk analysis in accordance with EN ISO 14971:2019 and develop and document risk mitigation plans desired. Previous experience with SAP MRP or QM module and TW desired
  • Experience with FDA 820.30, design controls
  • Experience with ISO 13485, design controls
  • Working knowledge of EU MDR requirements, particularly Annex I, the General Safety and Performance Requirements, (GSPR).
  • Excellent written and verbal communication skills with demonstrated ability to work cross-functionally across different functional groups and demonstrated ability to prioritize and manage multiple tasks and projects effectively and efficiently.

In return, we offer you
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.

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. 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 on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

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.

Equal Employment and Opportunity Employer/Disabled/Veteran

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Keywords: Philips Electronics North America Corporation, San Diego , Senior Design Quality Engineer, Other , Carlsbad, California

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