Senior Design Quality Engineer

About the role

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.

Responsibilities

• 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
• 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.

Requirements

• 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
• Proven experience/knowledge in Risk Management (ISO 14971), FMEA/DFMEA, Design Verification/Validation, Root Cause analysis and Defect Management
• 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
• Experience in utilizing Post Market Surveillance (PMS) insights/data analytics to lead continuous improvement throughout all stages of the product lifecycle
• Ability to share knowledge, insights regarding quality standards, and regulatory requirements
• A minimum of a Bachelor’s Degree (Required), in Quality, Engineering or similar disciplines

Qualifications

If you are the right fit, 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 are experienced in utilizing Post Market Surveillance (PMS) insights/data analytics to lead continuous improvement throughout all stages of the product lifecycle. You are 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.

Skills

Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Benefits

Details about our benefits can be found here.

Pay

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

Schedule

This is an Office role. May require travel up to 10%.