Senior Design Quality Assurance Engineer- Medical Device #2322

About the role

Ensure all requirements are met for the Product Lifecycle Process, Risk Management, Design Controls, and Usability Testing.

Work in fast-paced cross-functional teams to maintain and support quality-engineering methodologies, systems, and practices that meet company, customer, and regulatory requirements.

Responsibilities

• Provide quality and compliance input to project teams for decisions and deliverables (e.g., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Review, Design V&V, Usability Testing, Process Validation, and Labeling)
• Support Risk Management planning, updating and maintenance of the product risk documentation in compliance with regulatory standards
• Support Usability Engineering and planning documentation
• Provide key quality trending information and data
• Offer quality and compliance input for post-market activities such as design changes, supplier auditing, and customer complaint investigations
• Identify, prioritize, communicate, and resolve quality issues
• Lead implementation activities for post-market surveillance, product feedback, and corrective and preventive action programs
• Support internal and external audits

Requirements

• Bachelor’s Degree in Biomedical/ Mechanical/ electrical engineering or equivalent is preferred
• Minimum of 10+ years direct experience in medical device industry
• Ability to perform work accurately and thoroughly
• Ability to communicate effectively in written and oral form
• Excellent report writing skills essential along with the ability to find a solution or deal proactively with work related problems
• Ability to develop and sustain positive relationships with internal as well as external customers
• Identifying creative and efficient solutions to engineering challenges, Translating customer requirements into workable product ideas and solutions.
• Good analytical and problem-solving skills
• Broad and in-depth regulatory knowledge in medical device (Class II and III medical devices)
• Vast experience in writing/reviewing design control documents and compilation of DHFs
• Experience with Minitab Statistical software

Qualifications

ECI is an equal opportunity employer. All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.