Senior Software Design Quality Engineer job vacancy

Vacancy expired!

Job Title Senior Software 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

Provide software quality engineering support in design and development of medical device products. Facilitate the application of software design controls in product development and sustaining changes.

We are seeking candidates who can be onsite. We are also open to candidates who are willing to relocate to the Carlsbad, CA area. (relocation assistance will be provided.)

You are responsible for

Ensure software development and V&V processes meet quality and regulatory requirements of FDA and ISO
Provide ongoing software quality engineering support throughout the product software life cycle by participating in Software development reviews, code reviews and formal software technical reviews
Review new and modified product designs for quality characteristics, testability and traceable to product requirements.
Review verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance.
Review Design History Files and Technical Files for conformance to applicable requirements
Assist, when appropriate with internal and supplier audits.
Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
Contribute to software life cycle process improvements
Responsible for validating Non-Product Systems Software
Create all required documents for Non-Product Systems Software
Provide support on Non-Product Systems Software for various groups within the business

You are a part of

The Philips Hospital Respiratory Care business group, supporting products including 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

Bachelor's degree required
ASQ CQE, CSQE certification desirable
4+ years of software quality engineering experience within the medical device industry.
Familiarity with regulatory requirements e.g. IEC 62304, ISO 13485, 21 CFR Part 11, GAMP, 21 CFR 820 & ISO 14971.
Experience in risk evaluation techniques, such as DFMEA & Product Risk Assessment.
Test Automation experience is preferred.
Experience with Software Reliability is desirable
Understand the processes and intent of all aspects of the QMS related to Design Controls
Experience with test methods and standards for the design, verification, and validation of medical device products with emphasis around software development/testing.
Understanding of Object-Oriented Programming
Experience with analyzing data from SQL databases and writing SQL queries
Skilled in test plan development and root cause/failure analysis.
Excellent communication both written and verbal.

In return, we offer youA 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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ID: #20677193
State: California Carlsbad 92008 Carlsbad USA
City: Carlsbad
Salary: USD TBD TBD
Job type: Permanent
Showed: 2021-10-05
Deadline: 2021-11-08
Category: Software/QA/DBA/etc