R&D Engineer II

Fully participates in and successfully contributes to project teams typically including the following activities: product design and development, product design changes & troubleshooting, test method development & validation, testing & characterization of materials, development & assessment of specifications, research investigations, data analysis, report preparation etc. Responsible for design related documentation including EDS Package, prints and specifications in compliance with the pharmaceutical quality system (PQS). Demonstrates design control & PLCP knowledge through generation of high-quality deliverables. Uses design change process to ensure proposed changes are systematically and thoroughly analysed before beginning the change process. Maintain product performance through Quality Investigations and ensuring rigorous support for design changes. Designs and coordinates product testing and experiments. Summarizes, analyses and draws conclusions from test results. Performs troubleshooting on products/process problems as related to design, material or process. Prepares standard reports/documentation to communicate results to technical community. Interprets evolving global regulatory and standard requirements and assess impact to product design. Works cross-functionally & cross-site with project management, quality, manufacturing, regulatory, clinical and marketing to ensure project success. Work collaboratively with manufacturing to reduce product costs through design improvements Collaborates with vendors and supplier engineering teams to investigate and resolve supplier-related issues, ensuring full understanding of their impact on product design, quality, and performance. Provides technical input to supplier corrective and preventive actions (CAPA) and support implementation of design or specification changes that improve product robustness, manufacturability, and cost efficiency. Interfaces with vendors and physicians where projects require. Works independently to plan and schedule own activities necessary to meet timelines. Works under minimal direction regarding the progress of projects and special assignments. May seek guidance in resolving problems, interpreting established policies, procedures and practices. May train and/or provide work direction to technicians and interns. Must be able to provide technical guidance within a team and be an effective communicator within a multidisciplinary and international organisation. Demonstrates a primary commitment to patient safety and product quality. Level 8 qualification required in a relevant discipline including Biomedical, Mechanical, Polymers & Materials, Chemical Engineering. 5+ years industry experience within a regulated industry environment and with a track record of accomplishments. R&D/technical experience in the pharmaceutical or medical device industry essential. Experience in pharmaceutical product development, formulation, or manufacturing is an advantage. Experience in a PDP and/or Sustaining/Post-Commercial Support role an advantage. Excellent interpersonal and communication skills with good leadership abilities. Excellent analytical & problem-solving skills. Knowledge of polymers & materials characterization an advantage. Experience with rapid prototyping, product concepts, ideation an advantage. Demonstrated ability to work with key stakeholders across the globe. Self-Starter with the ability to work independently to plan, schedule and execute activities necessary to meet project timelines to schedule.