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Software Design Assurance Engineer

Company: Philips
Location: Colorado Springs
Posted on: January 11, 2021

Job Description:

Job TitleSoftware Design Assurance EngineerJob DescriptionIn this role, you have the opportunity to Support New Product Development projects within Image Guide Therapy with respect to software, firmware, and hardware from a design quality assurance perspective.You are responsible for * Leading the creation and review of risk management file to include the risk management plan, product hazard analysis, FMEAs, Software Risk Assessment, Risk Management Matrix, and Benefit Risk Determination.* Ensuring Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc. Expertise in ISO 14971, Risk Management for medical devices and IEC 62304 Medical Device Software.* Support in the creation and review of all medical device software documentation including cyber security assessments such as Data Protection, Privacy, and Security Assessments etc.* Understanding of all aspects of the QMS related to Design Controls. 21 CFR 820, ISO 13485* Development and status reporting of Quality and Reliability metric during phase reviews.* Participate in Design Verification Planning, Protocol Review, Report Review.* Participate in Design Validation Planning, Protocol Review, Report Review.* Participate in Process Validation Planning, Protocol Review, Report Review.* Provide Guidance on Quality aspects of PDLM Deliverables in addition to Design Verification/Validation.Your TeamOur solutions combine navigational tools such as catheters and guide wires with advanced software to help confirm the optimal treatment at the point of care: measurement technology, procedure-specific application support and on-board imaging and monitoring with improved anatomical and functional information to optimize therapy delivery. The IGT Devices organization consists of three segments: Coronary, Peripheral Vascular and Electrophysiology.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.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.* Electrical, Computer/Software, or Biomedical Engineering degree.* 8+ years of software quality or electrical engineering experience.* ASQ-CQE preferred.* Expertise in applying IEC 60601 and working knowledge with IEC 62304 and other relevant medical device standards* Knowledge in electrical and electronic manufacturing processes* Experience with software development lifecycle mythologies including Agile and SAFe* Familiar with software tools:* Defect tracking and management tools such a Jira or Clearquest.* Statistical software solutions such as JMP or Minitab* Design for reliability concepts and relating complaint history to reliability goals on new projects* Strong leadership skills and ability to work in a team environment* Highly motivated hands-on engineer with a proven record of meeting timelines and goals* Must possess strong analytical & problem solving skills* Non-Product Software Validation, IQ OQ PQ* Non-conforming product investigation, issue and defect tracking, CAPA* Post Market Surveillance and complaint reviewReady to start improving lives by putting your personal skills & passions to work? Apply Today! Not yet ready to apply? That's okay! Learn more about us by joining our Talent Network on LinkedIn or following us on Twitter at @PhilipsJobsNA.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/VeteranLI-PH1ContactIf you forgot your password, you can click the Forgot Password button on the Sign In screen to reset it.If you have any other questions regarding the recruitment process please refer to our FAQs. In case of technical difficulties with the website, please send an email to To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)

Keywords: Philips, Colorado Springs , Software Design Assurance Engineer, IT / Software / Systems , Colorado Springs, Colorado

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