Brief Description
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.
About The Role
The Sr. Mechanical Engineering consultant develops new products and / or sustains 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.
What You Will Do
* Contributes to design and development project teams typically including the following activities: product design and development, test of materials, product specifications development, engineering/technical reports to support product specifications, Risk management, usability studies, process capability studies, research investigations, report preparation, and process/test documentation ensuring compliance to design control requirements.
* Lead and support gap assessment and remediation of DHFs/Technical Files in compliance of 21 CFR and EU MDR requirements.
* Development and validation of new/revised test methods.
* Fabrication and evaluation of materials, components, devices, test fixtures and prototypes.
* Generation, review and approval of all necessary design control documentations.
* Perform design verification and validation .
* Identification of device improvement opportunities (quality, cost, performance).
* Lead effectively within a technical and project team environment, including conducting meetings and presentations, Planning and tracking projects, etc.
* Work extensively with product managers, other engineers, technicians and cross-functional specialists, physicians, nurses, internal and external suppliers, and contract manufacturers.
* Provide mentorship and work direction to junior-level engineers, engineering technicians and other cross-functional support personnel.
* Build Quality into all aspects of their work by maintaining compliance to all quality and regulatory requirements.
* Contributes to team effort by accomplishing related duties as requested.
What We Look For
* Advanced computer skills including MS Office applications
* Word/Excel/powerpoint/project/visio/Teams)
* Minitab statistical analysis software are required
* SolidWorks experience preferred. Experience with electronic data management system.
* Bachelor's Degree in Engineering or equivalent work experience.
* Minimum of 7 (seven) years direct design experience in medical device industry.
* Some experience with durable medical capital equipment in addition to single-use-devices is preferred.
* Excellent written and verbal communication skills with good presentation and technical writing skills.
* Collaborative attitude with the ability to work well in a team environment.
* Strong engineering, design, and analysis skills.
* Experience with medical devices from concept to commercialization.
* Understanding of FDA Quality Systems Regulations and EU MDR Regulations
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.