R&D Engineer II; Medical Device

About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long‑term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects.

Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long‑term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects.

Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

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

• Support design history file remediation activities associated with the client’s division, including as needed but not limited to:
  Design Inputs, Design Outputs, Design Verification, Design Validation and Risk Management.
• Interface with client’s team members along with coordinating activities within our client’s Quality Management System.
• Additional items discussed between client and ECI as determined reasonably will not require scope re‑evaluation. किश.
• Develop new products and/or sustain current products including single use devices, and capital equipment devices with software and hardware (medical device systems) with minimal supervision to develop, maintain or improve current released device design and/or quality. Support team to develop and execute plans for a design and development/design change projects following design control requirements.

• Bachelor’s Degree in Engineering or equivalent work experience.
• 3 - 7 year direct R&D experience in medical device industry.
• Experience with durable medical capital equipment in addition to single‑use devices is preferred.
• Excellent written and verbal communication skills with good Fate presentation and technical writing skills.егка.
• Collaborative attitude with the ability to work well in a team environment.
• Strong engineering, design, and analysis skills along with experience with medical devices from concept to commercialization.
• Understanding of FDA Quality Systems Regulations.

Mid‑Senior level

Full‑time

Engineering and Information Technology

Business Consulting and Services

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,Animate, 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.