Development Quality Engineer I

The Development Quality Engineer I works with product development teams to design and qualify new life-saving products. You will help develop and implement appropriate quality system elements to ensure the high-quality level of new and existing products and to ensure their compliance to all applicable regulations and standards. Help products safely and efficiently get to market by following standards and procedures to analyze situations and data from which conclusions can be readily obtained.

Responsibilities

Participate in the product development and qualification activities for new and existing products; Participate in Product Development teams; Develop testing, inspection methodology, and documentation for new and existing products; Design and install quality sampling systems and procedures utilizing statistical analysis; Design or specify inspection and testing equipment to meet product requirements; Perform failure analyses and defect investigations; Analyze and apply design control standards; Recommend revision of specifications, procedures, and work instructions for device design and process improvement; Interface with other internal departments, customers, and suppliers on product and quality-related issues; Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures; Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company; Ensure other members of the department follow the QMS, regulations, standards, and procedures; Perform other work-related duties as assigned

Requirements

Associate’s or Bachelor's degree in Engineering, a Life Science or a related field, plus quality engineering or relevant experience, or equivalent combination of education and experience; Familiarity with QSR, ISO and other applicable regulations and laws required; Excellent verbal, written, and interpersonal communication skills; Proficiency with MS Word, Excel, and PowerPoint

Nice to have

Medical device environment experience

Benefits

Collaborative teamwork environment where learning is constant, and performance is rewarded; Opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases; Competitive compensation package plus benefits and equity program when applicable; Medical, dental, vision, life, AD&D, short and long-term disability insurance; 401(k) with employer match; Paid parental leave; Eleven paid company holidays per year; Minimum of fifteen days of accrued vacation per year, which increases with tenure; Paid sick time in compliance with applicable law(s)