Associate Design Quality Engineer

Description

The Associate Design Quality Engineer participates in all aspects of new product development in order to ensure the highest level of quality and their compliance to applicable regulations and standards.

Responsibilities

• Represent Quality Engineering on cross-functional teams, interfacing among multiple departments and teams such as Manufacturing, R&D, Regulatory Affairs, Operations/Planning, and Marketing.
• Apply knowledge of Design Control principles and Quality Engineering to positively influence new product development efforts.
• Review and approve engineering change orders on assigned projects.
• Participate in the creation or review of Design Inputs, Design Outputs, Design Verification, Design Validation, DFMEA, Risk Management Report.
• Assist in creation and implementation of risk analysis documentation for new products with identified hazards and harms.
• Provide guidance, within the scope of quality system, to ensure regulatory compliance to standards within designated projects and product lines.
• Apply statistical rationale to plan, analyze, and interpret engineering test data collected during Design Verification Testing.
• Perform other duties as assigned.

Qualifications

• Bachelor’s degree in Engineering or technical field.
• Minimum 1 year of experience in a design quality engineering role in medical devices.
• Excellent, proven interpersonal, verbal, and written communication skills
• Detail oriented; deliver high quality work product consistently and on time.
• Ability to thrive in a fast-paced and dynamic work environment.
• Certification in Six Sigma Black Belt / ASQ certification preferred.

Inari Medical offers competitive health and wealth benefits for our employees. The base pay range for this position is $65,000 - $80,000. A range of factors, including location, skills, and experience, will be considered. Actual compensation may vary. Inari Medical, Inc. advises applicants that employment is subject to completion of a successful background check.