Our client a high potential and well funded start up are currently seeking a Senior R&D Engineer to join their team. Reporting to Director of R&D Senior R&D Engineer will support the product development of a cutting edge device through design development, verification, clinical trials, validation and regulatory approval. This position offers the opportunity to join an exciting early stage company.


Role/Responsibilities

• Responsible for developing device specifications, in line with user needs and Design Inputs, including innovative solutions. Provide technical and project leadership for R&D activities
• Design sub assemblies and finished devices, including design selection, material selection and assembly method selection. Create detailed component and finished device assembly drawings/specifications
• Build and test prototypes; analyse test data and interpret to identify optimal solution
• Identify and select product materials, assembly methods and define process settings. Participate in sourcing, testing and approving materials.
• Develop test methods for product evaluation and validation. Develop and execute test method validations.
• Leverage and liaise with external resources to achieve project goals
• Drives risk management for sub-assemblies under their responsibility and drives a system level risk based design approach.
• Ensure quality in the product’s design for durability, usability, reliability, functionality, marketability, and manufacturability
• Ensure interactions with colleagues/stakeholders fully reflects the company values:

• One Team: working together to ensure the whole is greater than the sum of the parts
• Personal Ownership: deliver on commitments
• Open Communication: Honest open-minded communication
• Fun: celebrate the successes
• Continuous Learning: at an individual and company level
• Solution Orientated: Identify problems but focus your energy on solutions
• Quality Focused: patient safety comes first

• B.S. or master degree in mechanical engineering, biomedical engineering, or related disciplines
• Minimumfive years of related experience in medical device mechanical design/product development
• Strong design and technical ability based on a broad and deep knowledge of fundamental engineering principles. Prior experience in cardiovascular/nitinol/delivery system medical products highly preferred
• Strong capability of assessing in vitro and in vivo properties of device/device components including knowledge of the implant/tissue interface and challenges.
• Detailed knowledge of Design Controls and FDA, GMP, QSR and ISO 13485 requirements.
• Experience interfacing with clinicians and reducing feedback to device concept
• Excellent organizational and time management skills
• Experience designing with Nitinol for Class III implant devices is a significant advantage