RnD Engineer (Medical Device)

Lead design risk identification and related mitigation activities Test execution including but not limited to test method validation, test fixture design, verification test protocol and report release
New product development implementation from an R&D and design perspective
Documentation of risk management procedures but not limited to creation of risk management plan, reports and creating engineering rationales.
Support & lead design controls of new product development projects from concept to product launch and global regulatory submissions.
Support and lead design concept creation, computer aided design, rapid prototyping, and print release
Define design inputs, generate design concepts, and perform significant and timely design evaluations (i.e., tolerance analysis, FEA, simulated use testing, dry labs and wet tissue labs etc.)
Lead R&D team in design transfer to manufacturing engineering and/or suppliers to optimize designs for manufacturability and assembly
Work within cross-functional project teams including R&D, Quality Assurance, Regulatory, and Medical Affairs for obtaining necessary reviews and approvals.
Documents test results, design history, risk analysis, and other activities as required by the company's quality management system.

Mandatory Skills

Good knowledge of medical devices regulatory process.
Regulatory data analysis, mapping and migration activities from legacy systems.
Ensure timely registration of all new products and obtaining of relevant licenses.

Desired Skills

Must have ability to develop and maintain business partnerships at all levels of the organization.
Expertise / proven record of working with onsite-offshore business model on regulatory and / or mechanical engineering projects.
Adheres and comply to work instructions, Standard Operating Procedures.

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