We’re looking for a driven and passionate Product Development Engineer to join our rapidly growing startup.
You will work closely with the technical and quality team to complete verification and validation activities of our product portfolio. You will report directly to our Quality and Regulatory Manager with more than 25 years of experience in the field.
As a Product Development Engineer, you will be involved with product development and quality related design activities. You need to have a good technical understanding of biomedical engineering/ medical science and keen to learn/ implement quality requirements in accordance with regulatory requirements/ISO13485.
You will be very involved with a wide range of technical, quality, and commercialisation activities. If interested, you will have an opportunity to learn A-Z of medical device commercialisation, from product development and testing to regulatory submission.
What You’ll Bring
- Ideally, prior involvement, 2-3 years’ experience in a medical device organisation or similar technical role
- University degree qualified in a relevant engineering or scientific field
- Project management skills, with experience involving multiple stakeholders and complex timelines
- Proactive attitude and willing to take initiative
- High attention to details
- Organised & self-sufficient
- Research technical and scientific publication with the focus on biomaterials and regeneration of skin, cartilage and bone.
- Document findings and discuss outcomes with CTO and Research Manager.
- Have access to ISO13485 training with a focus on product design and development as well as ISO1497 medical devices risk assessment.
- Participate in design and development activities and generate and maintain the product development plan in accordance with regulatory requirements.
- Manage the product requirements documentation in accordance with predefined standard operating procedures. Product requirements shall be identified from the following sources:
- Applicable ISO and industry standards
- Applicable regulations
- Establish traceability of requirements through the product development lifecycle.
- Conduct and document risk analysis in accordance with the risk management plan by understanding technical and scientific risks.
- Develop the product verification and validation plan and associated product validation protocols.
- Assist with non-clinical product validation testing and generate validation reports.
- Participate in cross-functional team meetings relating to Quality, Regulatory, Design and Development, Manufacturing