Role OverviewAs a Quality Engineer 2, Design Assurance, you will fulfill the hardware design assurance role on new product development and sustaining projects. You will contribute to planning and execution of design controls, risk management, test method development and validation, and design verification/validation for new and existing products. You will support Regulatory Affairs with creating submissions and responding to submission questions.
What You Will Do
Your main day-to-day responsibilities will include understanding product user needs and assuring they are translated to the design, while ensuring compliance to usability and human factors standards and regulations. You will contribute to new product development Technical Reviews and Design Reviews, and partner with R&D to determine and define design inputs, design outputs, and design input/output relationships.
Why It Might Be a Fit
To be successful in this role, you will need to have a strong understanding of applicable standards and regulations, knowledge of electrical and electronic manufacturing processes, and the ability to utilize applied statistics in data analysis. You will also need to be able to work independently and with minimal direction, and have excellent interpersonal skills for working in a team and as an individual contributor.
Requirements
- BA/BS in Engineering or physical sciences
- Three years of related experience in a regulated industry
- Understanding of applicable standards and regulations
- Knowledge of electrical and electronic manufacturing processes
- Ability to utilize applied statistics in data analysis
- Ability to work independently and with minimal direction
- Excellent interpersonal skills
Benefits
- Comprehensive benefits package
- Paid time off
- Health insurance
- Retirement plan
- Learning budget
- Parental leave
- Wellness programs
- Visa/relocation assistance
- Remote flexibility
- Stipends
- Bonus/commission
- Paid holidays
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