Design Quality Engineer

Philips•Bedford, MA

1d•$103,000 - $163,000•Onsite

About The Position

The Design Quality Engineer is accountable for design quality, risk management, sustaining and complaint investigations for Philips Image Guided Therapy products. Ensures that appropriate quality plans are followed with a focus on sustaining and product complaint investigations. Provides input to design I/O 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. Maintain Desing history files updated. Provides effective input for Risk Management activities, and of all design related activities during the product/system lifecycle. Perform routine risk management updates. Performs technical assessment on product quality performance and post-market product quality analysis. 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

Minimum of 3+ years’ experience in FDA regulated medical device environments, with a focus on Design Assurance, Sustaining and Post Market Complaint investigations.
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.
Experienced in utilizing Post Market Surveillance (PMS) insights/data analytics to lead continuous improvement throughout all stages of the product lifecycle.
Able to share knowledge, insights regarding quality standards, and regulatory requirements.
Minimum of a Bachelor’s Degree (Required), in Quality, Engineering or similar disciplines.
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
May require travel up to 10%.

Responsibilities

Ensures that appropriate quality plans are followed with a focus on sustaining and product complaint investigations.
Provides input to design I/O 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
Maintain Desing history files updated.
Provides effective input for Risk Management activities, and of all design related activities during the product/system lifecycle
Perform routine risk management updates.
Performs technical assessment on product quality performance and post-market product quality analysis.
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.