Senior R&D Engineer

Our client, a high potential and well‑funded start‑up, is currently seeking a Senior R&D Engineer to join their team. Reporting to the Director of R&D, the 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.

• 
  
• 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 solutions.
  
• 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.
  
• Drive risk management for sub‑assemblies under responsibility and adopt 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 reflect 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‑Oriented: identify problems but focus energy on solutions.
  
• Quality‑Focused: patient safety comes first.
  

• 
  
• B.S. or master degree in mechanical engineering, biomedical engineering, or related disciplines.
  
• Minimum five 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.
  

The above role profile is not designed to cover a comprehensive listing of activities, duties or responsibilities that are required of the employee. xcfaprz Duties, responsibilities and activities may change or new ones may be assigned from time to time.