Our client a hight potential medical device start up are currently seeking a Principal R&D Engineer to join their team. Reporting to the VP of R&D the Principal R&D Engineer will play a lead role in the product development of a cutting edge device through design development, verification, clinical trials, validation and regulatory approval.


Role/Responsibilities:

• Lead design and development at a system level, generation of detailed specifications, including review and approval of sub-systems.
• Design systems, including robust design selection, material selection and assembly method selection. Detailing finished device specifications to ensure a robust and right first time device.
• Manage the sourcing, building and testing of systems; ensuring detailed and comprehensive data analysis to drive the device design in the optimal direction
• Define and manage the execution of comprehensive test suites to fully understand device design, risk and verify & validate it in line with device specifications.
• Proactive management of risks throughout the product lifecycle to drive risk management at an overall system level, ensuring risk based design.
• Ensure the device development follows good Design Control practices, in line with IOS13485. Generating a complete, audit ready, Design History File.
• Ensure Quality in the product’s design for durability, usability, reliability, functionality, marketability and manufacturability
• Lead technical discussions with multiple internal and external stakeholders, adapting s and supporting material to suit the discussion to ensure clear understanding of all parties.
• Proactively ensure Company Goals are achieved
• Ensure interactions with colleagues/stakeholders fully reflects the company values:

• B.S. or masters degree in mechanical engineering, biomedical engineering, or related disciplines
• Eight years of related experience in medical device mechanical design/product development
• Cardiovascular medical product development experience preferred
• Comprehensive ability to assess in vitro and in vivo properties of device/device components including knowledge of the implant/tissue interface and challenges.
• Detailed working knowledge of FDA, GMP, QSR and ISO 13485 requirements.
• Experience interfacing with clinicians and reducing feedback to appropriate designs
• Excellent organizational and time management skills