Senior R&D Engineer

Position: Senior R&D Engineer #4896
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About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients rely on our diverse perspectives and decades of expertise to tackle their toughest challenges. We pride ourselves on providing transformative solutions with sustainable, long-term value. ECI has a proven track record in full product lifecycle consulting on challenging projects. Our collaborative culture, welcoming team, and flexible employment and benefit options help us maintain strong relationships with talented individuals in the industry.

Role Overview

As a Senior R&D Engineer, you will support DHF remediation activities for our client’s division.

Responsibilities

• Support design history file remediation activities, including Design Inputs, Design Outputs, Design Verification, Design Validation, and Risk Management.

• Interface with client’s team members and coordinate activities within their Quality Management System.

• Create, update, and approve documentation within the client’s documentation management system related to product lines and design history files.

• Develop and sustain products such as single-use devices and capital equipment with software and hardware, supporting design and development projects following design control requirements.

Qualifications

• Bachelor’s Degree in Engineering or equivalent work experience.

• At least 5 years of direct R&D experience in the medical device industry.

• Experience with durable medical capital equipment and single-use devices is preferred.

• Excellent communication, presentation, and technical writing skills.

• Collaborative attitude and ability to work well in a team.

• Strong engineering, design, and analysis skills, with experience from concept to commercialization.

• Knowledge of FDA Quality Systems Regulations.

Additional Information

ECI is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition, veteran status, marital or citizenship status, or any other protected class.

Applicants must be authorized to work in the U.S. without visa sponsorship now or in the future. ECI does not sponsor work visas for this role.

Job Details

• Seniority Level: Mid-Senior level

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Employment Type:

Full-time

• Job Function:
Engineering and Information Technology

• Industries:
Business Consulting and Services

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