About the position
The Product Quality Engineer is accountable for oversight of system and hardware quality and risk management throughout the product life cycle. This role ensures that appropriate quality plans are made that include all stages of the lifecycle of the product and supports Quality plan design. The engineer validates key design inputs for usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs. They provide effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle. Additionally, the engineer performs independent technical assessment on product quality performance and post-market product quality analysis, leading quality related problem solving and root cause analysis during design and manufacturing. They create and use post-market analytics, statistics and deliverables to report on product quality performance in the field and initiate field actions when required.
Responsibilities
- Ensures that appropriate quality plans are made that include all stages of the lifecycle of the product and supports Quality plan design.
- Validates key design inputs for 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.
- Leads quality related problem solving and root cause analysis during design and manufacturing.
- Creates and uses post-market analytics, statistics and deliverables to report on product quality performance in the field and initiates field actions when required.
Requirements
- 2+ years of Design Quality Engineering experience in a regulated environment, preferably within Medical Device.
- Bachelor's degree in a scientific discipline, Engineering preferred or equivalent.
- 2+ years of experience in Assessing quality plans and product designs, reviewing test and other performance data, Analyses of market feedback, Leading root cause analysis and quality problem solving.
- Ability to successfully perform the minimum Physical, Cognitive and Environmental job requirements with or without accommodation.
Benefits
- Generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- Stock purchase plan
- Education reimbursement
