Senior Design Quality Engineer

The Senior Design Quality Engineer is accountable for system/hardware design quality and risk management throughout the product life cycle for Philips Sleep & Respiratory Care products.

Your role:

• Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design
• Provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met.
• Validates key design inputs: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
• Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle
• Performs independent technical assessment on product quality performance and post-market product quality analysis. Provides analytics to the Business on the efficacy and efficiency of the design and product realization processes.
• Performs post-market data analysis/statistics to report on product quality performance in the field and to the Business on the efficacy and efficiency of the design and product realization processes.
• Initiates field actions/CAPA when required.

• You have a minimum of 5+ years' experience in FDA regulated medical device environments, with a focus on Design Assurance/Control and strong Understanding of ISO 13485 / 9001 / FDA / Canada
• You have proven experience/knowledge in Risk Management (ISO 14971), FMEA/DFMEA, Design Verification/Validation, Root Cause analysis and Defect Management.
• You have detailed experience in identifying, promoting, and supporting processes and design quality tools for use in tracking/preventing product defects, design traceability, and Design for Reliability.
• You're experienced in utilizing Post Market Surveillance (PMS) insights/data analytics to lead continuous improvement throughout all stages of the product lifecycle.
• You're able to share knowledge, insights regarding quality standards, and regulatory requirements.
• You have a minimum of a Bachelor's Degree (Required), in Quality, Engineering or similar disciplines.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

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 improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details:

• The pay range for this position in Murrysville, PA is $92,000 to $146,000.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.