Senior R&D Engineer Job specification

Opportunity

This is a key role in the design and development of a cutting edge structural heart device, bringing it through all phases of the development cycle into clinical trials. We are looking for ambitious people who love to innovate, are committed to making things happen and want to contribute to saving human lives. This is a great opportunity to join an early-stage company with huge scope to grow your skills and experiences.

Roles and Responsibilities:

  • Working as part of the R&D team to design and develop a novel transcatheter heart valve device in line with user needs, including generating creative solutions to problems

  • Manage and drive project activities to ensure timely completion of project milestones.

  • Liaise where necessary with Physicians to understand and validate the specific user requirements

  • Identify and manage key risks throughout the product lifecycle

  • Contribute to innovation through filing of disclosures and patents.

  • Responsible for developing device specifications, in line with user needs and Design Inputs. Create detailed component and finished device assembly drawings/specifications

  • Identify and manage vendors to obtain components, processes, and equipment

  • Develop test methods and fixturing for product verification and validation; analyse test data and interpret to identify optimal solution

  • Ensure quality in the product’s design for durability, usability, reliability, functionality, marketability, and manufacturability

  • Develop and manage manufacturing activities for prototype and pilot production builds

  • Reports directly to the Chief Technology Officer

Requirements:

  • B.S. or Masters degree in Mechanical Engineering, Biomedical Engineering, or related disciplines
  • Minimum of four (4) 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 systems products is highly preferred
  • Excellent SolidWorks skills, experience in the use of Parametric Modelling in SolidWorks
  • Experience in multi-tasking, project planning, and time-line management via GANTT chart
  • Class III medical product development experience involving clinical trials highly preferred
  • Strong knowledge of material selection for long term implants, capability of assessing in vitro and in vivo properties of implantable devices and their components, knowledge of the implant/tissue interface and the challenges associated with chronic implants.
  • Working knowledge of FDA, GMP, QSR and ISO 13485 requirements.
  • Excellent organisational and time management skills
  • A good team player who works well in a small, fast-paced team environment

Availability to travel is required