- Driving, coaching, supporting and training (or leading in workshops) the use of Requirements Engineering, Risk Management, FMEA and CTS/CTQ flow down best practices and relevant techniques that assure identification and End-2-End (E2E) control of software safety and quality characteristics. Next to that, those best practices to define objective verification, validation and useability evaluation strategies and acting as a go-to Subject Matter Expert for project team(s), business functions and design quality engineers in our team(s) on these Design for software Quality, Reliability, and Testing (DfX) best practices.
- Optimize the reliability of software through a software reliability plan.
- Driving Software Design Quality and Reliability improvement identification in New Product Introductions and Sustaining product development for stand-alone software products (SaMD).
- In partnership with other functions, defining and managing the holistic patient and user safety, quality and reliability strategy and approach.
- Validates key design inputs like useability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy serviceability, sustainability, and costs. This includes leading the target setting for Quality and Reliability aspects.
- Supporting the creation and review of medical device software documentation. Ensuring correctness and completeness of requirements and test evidence traceability through the V-model, with specific emphasis on CTQs and CTSs.
- Support the creation and review of risk management files and effective use of feedback from post-market surveillance.
- PhD or Masters (MSc) degree in Computer Engineering, Computer Science, Systems Engineering or Reliability Engineering with 7+ years of relevant experience; preferably in Quality- or Reliability Engineering role in a software development (embedded or stand-alone) environment in the medical or aerospace industry.
- Certification in Software Quality Engineering (CSQE) from ASQ or other bodies is desirable..
- Experience with Software Reliability Engineering (SRE) models including growth models.
- Expert level experience on SRE activities; Software fault tolerant design, Fault prevention techniques implementation, software FMEA and FTA, design for testability methods,
- Fault detection and removal activities including efficient test design & test automation.
- Expert level experience in code review techniques in a wide range of platforms, excellent problem-solving skills and root cause analysis in Software. Able to read and understand multiple programming languages.
- Hands-on experience with both automated and manual software tests including tools from HP, IBM and Micro Focus, etc. is preferred.
- You have a DfSS Black belt certification.
- Excellent communication skills, able to clearly and concisely summarize complex technical problems.
- You combine analytical and conceptual thinking, physical insight, system view, flexibility and a hands-on mentality to deliver sustainable results and creative solutions.
- Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR. Advanced level knowledge of IEC62304, IEC62366 and ISO14971 has a strong preference.
- Ability and willingness to work at least 3 days in office.
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Sr. Software Design Quality Manager - Bangalore, India - Philips
Description
Job Title
Sr. Software Design Quality ManagerJob Description
Sr. Software Design Quality Manager
You will be part of the global Philips Quality organization and will be reporting within the Design Quality team for IGT-Systems. As member of this team, you contribute to our constant strive for further product quality improvements, so we continuously exceed both internal and external stakeholder expectations.
We are looking for a leader by example with deep understanding of design capabilities for design for software Quality, Reliability, and Testing (DfX) best practices. Someone with a proven track record in applying those to design, develop and realize safe, effective and reliable complex medical systems.
Your role:
You're the right fit if:
We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life, not just as a job. We're looking for someone who can inspire others to adopt this mentality of prioritizing patient safety and quality above all else in a relentless pursuit to improve the quality of life for the billions of people Philips brand touches each year.
Specific skill requirements for this role include:
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
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