Sr R&D Engineer

Cardinal Health•Mansfield, MA

12h

About The Position

As a Senior R&D Engineer, you will be instrumental in driving the development of innovative medical products from conception to launch, ensuring adherence to R&D milestones. Your expertise will be crucial in researching and selecting medical-grade materials, identifying and resolving technical challenges, and coordinating extensively with cross-functional teams to manage product development activities. This role requires a strong understanding of FDA Quality System Regulations (21 CFR 820), ISO 13485, and GMP standards, with a focus on design control, risk management, and maintaining comprehensive Design History Files.

Requirements

Bachelor's degree in Biomedical, Mechanical, Plastics, or Materials Engineering preferred
2+ years product development experience in the medical device or regulated disposables industry preferred
Knowledge of FDA Quality System Regulations (21 CFR 820), ISO 13485, and GMP standards.
Proficiency with statistical analysis software (preferably Minitab) and risk analysis tools.
Experience with PLM Software

Nice To Haves

Preferred Certifications: DFSS

Responsibilities

Meet R&D milestones within the broader product launch schedule.
Ensure raw materials meet medical-grade standards consistently.
Identify milestone obstacles and develop solutions to well defined technical problems.
Conduct research on the structures and properties of materials (fibers, filaments, foams, films, nonwovens, wovens, adhesives, etc.,) to obtain information that could be used to develop new products or enhance existing ones.
Design a product within COGS (Cost of Goods Sold) targets.
Coordinate with cross-functional teams (marketing, sales, manufacturing, sourcing, packaging, regulatory etc.) as well as with nurses/clinicians to manage product development activities.
Execute design control deliverables, support product(s) risk management execution
Ensure products are complying for the claimed shelf-life, biocompatibility, and ‘material of concern’ requirements.
Create and maintain DHF (Design history file) to ensure Product lifecycle management complies to internal/external audits.
Support or execute design transfer for production.
Lead projects and effectively communicate to team members and management on the project status.
Participate in the Maintenance of Business activities and support manufacturing facilities.
Create and deliver effective multi-media presentations that are appropriate for reaching cross-functional audience.