R&D Engineer I

Anika Therapeutics•Bedford, MA

21d

About The Position

This position is responsible for providing general support of R&D on various existing and new product development projects. This technical role will support R&D scientists and engineers while working closely with Operations, Manufacturing Engineering, Quality, and Regulatory executing activities associated with design control and product launch.

Requirements

Bachelor’s degree in Engineering or related discipline and demonstrated working knowledge of scientific principles
Working knowledge of ISO 14971 Risk Management for Medical Devices and ISO 10993 Biological Evaluation of Medical Devices
Working knowledge of cGMPs, QSRs, MDDs and MDRs
Familiar with FDA, ISO 13485, MDSAP, TGA, ANVISA and other regulatory agency regulations.
Familiarity with the principles of Design Control
Strong writing and presentation skills.

Responsibilities

Works with various departments of the organization including Engineering, Marketing, Operations, and Quality & Regulatory for effective communication and input for existing and new product development projects.
Supports EU MDR efforts for R&D including design control, biocompatibility and risk management.
Participates in / manages inhouse or outside testing necessary to fulfill regulatory and design control requirements, including packaging and sterilization validations, component inspections etc.
Contributes to Design History Files with necessary inputs ensuring design control documentation is complete, accurate and in compliance with FDA and EU Regulations.
Interfaces with Contract Manufacturers and suppliers to ensure product development issues are resolved under established timelines.
Records experiments in an organized laboratory notebook and generates necessary technical reports and documentation.