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Staff Engineer, Quality Design Assurance
We create meaningful work that impacts the future of healthcare.
This role is ideal for someone who challenges conventional thinking and drives positive change.
As a key team member in the Design and Reliability Assurance Engineering department, you will lead risk management activities and collaborate with cross-functional teams to plan, organize, and report on these efforts.
You will be responsible for driving continuous improvement in risk management work products and deliverables, supporting new product development, sustaining engineering, and continuous improvement projects of varying scope and complexity.
Key Responsibilities:
* Provide leadership and expertise in risk management and human factors throughout project phases.
* Develop efficient processes, procedures, and tools to support continuous improvement in risk management.
* Establish and implement key performance indicators (KPIs) and metrics for the risk management process.
* Conduct assessments to identify areas for improvement in risk management.
* Lead planning, organizing, and reporting of risk management activities through collaboration with cross-functional teams.
* Support New Product Development, Sustaining Engineering, and Continuous Improvement projects.
* Collaborate with internal customers and external partners, participating in project teams through all phases of product development.
Requirements:
* Bachelor's degree in engineering or science.
* 8 years of experience in medical device or regulated industry with knowledge of ISO 14971, MDD, IEC 62366, and FDA QSR.
* Strong analytical skills and problem-solving abilities.
* Working knowledge of DFSS techniques and statistical sampling and analysis tools.
* Excellent organizational, verbal, and written communication skills.
* Proficient in MS Office Suite and statistical software.
* Able to work independently and prioritize projects to meet organizational goals.