Software Quality and Reliability Leader
1 day ago
As a Software Quality and Reliability Leader, you will play a critical role in ensuring the development of high-quality software products that meet regulatory requirements.
About the RoleIn this position, you will be responsible for designing and implementing comprehensive software quality plans that cover all stages of the software lifecycle.
- You will validate key product design inputs such as usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy serviceability, sustainability, and costs.
- Effective oversight over the execution of the SW Quality Plan will be provided by you, which includes risk management activities and all design-related activities during the software lifecycle.
- You will ensure software design quality and reliability targets are met for every project milestone.
- Leading software quality-related problem-solving is an essential part of your role.
- Using post-market data analysis to report on software performance in the market (provide feedback to manufacturing, suppliers or design teams) and initiate field actions when required.
- You will act as a single point of contact for project team(s).
- A substantial contribution to ways of working of combining Agile with medical software development is expected from you.
To succeed in this role, you should have a Bachelor's engineering degree with 15+ years of experience / Master's degree with 13 years of experience; preferably in Software- or Reliability Engineering role in the medical or aerospace industry.
- You should have ability to define detailed SW Quality and Reliability plans for new SW product development to ensure SW products are Safe, Effective and Reliable.
- Ability to perform SW Risk Management and SW Design FMEAs with teams on all new products and recommend design changes to improve product safety and product quality; and subsequent assurance that control measures are translated in appropriate (critical) requirements.
- Strong exposure to application of Design Controls; ability to do thorough Design Reviews during new product development to ensure robustness of SW product design.
- Ability to partner with V&V teams to assure thorough SW Verification, Validation and Useability testing.
- Analyze development and field data for trends of Product Safety, Quality and Reliability performances and areas for further improvements of Product design and related development processes.
- Ability to conduct reliability analysis to assess the risks associated with design concepts.
- Perform statistical data analysis, regression modeling, reliability growth assessment and reliability prediction.
- Experience with adequate and accurate review of DHF and DMR documents.
- Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, IEC 62366, IEC 62304 and ISO 14971.
- Certified DfSS greenbelt or blackbelt.
- Experience with working in multidisciplinary teams in a high-tech R&D environment.
- Effective interpersonal, written and oral communication skills are expected.
- Ability and willingness to work at least 3 days in office.
We offer a competitive salary range $180,000 - $220,000 per year, depending on your qualifications and experience. Our benefits package includes health insurance, retirement plan, paid time off, and opportunities for professional growth and development.
About PhilipsWe are a health technology company that believes every human matters. We strive to exceed both internal and external stakeholder expectations by continuously improving our products and services. Join us and contribute to making a meaningful impact on people's lives.
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