ECI · 1 day ago
R&D Engineer II (Medical Device) #5075
Marlborough, MA
Full-time
Onsite
Mid, Senior Level
3+ years expECI is a global leader in professional consulting services for the life sciences industry, committed to providing transformative solutions. As an R&D Engineer, you will support design history file remediation activities and develop new products in the medical device sector, working closely with clients and adhering to design control requirements.
BiotechnologyConsultingLife ScienceProject Management
No H1B
Responsibilities
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. Product lines associated with the division and design history file documentation creation, updates, and approval within the client’s documentation management system
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. Support team to develop and executes plans for a design and development/design change projects following design control requirements
Qualification
Required
Bachelor's Degree in Engineering or equivalent work experience
3 - 7 year direct R&D experience in medical device industry
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 along with experience with medical devices from concept to commercialization
Understanding of FDA Quality Systems Regulations
Preferred
Experience with durable medical capital equipment in addition to single-use-devices
Company
ECI
ECI (Enhanced Compliance Inc.) stands as a beacon of excellence in the life sciences consulting arena.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Michael Boyer
Chief Financial Officer
Shital Patel
Chief Operating Officer
Company data provided by crunchbase