Overview
Due to continued expansion of our operations, we are seeking applications from a suitably qualified and experienced R&D Engineer II
Job Purpose
Develops products, materials, or test methods for medical device products in the treatment of heart disease specifically in the development of Drug Eluting Stents
Under limited supervision/guidance, compiles, analyzes, and reports operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials.
Key Responsibilities
As R&D team member works co-operatively in a development team with process development, quality, manufacturing, regulatory, clinical and marketing to ensure project success.
Knowledgeable in the areas of stent drug/polymer coatings especially biodegradable polymer coatings
Knowledgeable in the design features of stent delivery systems
Knowledgeable in the area of drug performance aspects of Drug Eluting Stents
Prepares standard reports/documentation to communicate results to technical community
Ability to present information to team on critical issues in a concise and efficient manner
Proven ability to use data analysis techniques to provide statistical support of scientific rationale – Summarizes, analyses, and draws conclusions from test results.
Participates in design review and designing products and processes for manufacture
Ensures the efficient transfer of prototype and pilot products to full production status and supports these product lines on an ongoing basis.
Communicates changes in project milestones and writes project reports as required
Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
Demonstrate a primary commitment to patient safety and product quality.
Ensure regulatory compliance to GMP’s of all medical device regulatory agencies (e.g., FDA, ISO and MDD).
Qualifications
Primary Degree in either Mechanical, Polymers, Chemical, Materials or Biomedical Engineering.
Strong R&D experience preferably in the area of Drug Eluting Stents
Excellent interpersonal and communication skills with good leadership abilities.
Excellent analytical and problem solving skills.
Candidates should have a proven track record of working in a fast paced environment with strong technical capabilities and be capable of handling multiple development aspects of assigned projects.
