Title: Product Development Engineer (Validation & Verification)
Location: The Digital Hub, Rainsford St, Dublin 8.
Benefits: Excellent salary, flexible working hours and Health insurance


Role:
As a Product Development Engineer you will gain exposure to a range of technologies at the forefront of biomedical research and every phase of the product development lifecycle from initial concept development through to commercialisation. Expand its engineering department to support development of flagship and next-generation medical device products that combine auditory stimulation, nerve stimulation, wireless communications and physiological sensing technologies



Company:
My client are a Medical Device company who started up in 2010 and have developed and patented a bimodal neuromodulation technology that it is evaluating for neurological disorders. The lead application of this technology is through a device which has been shown to soothe and relieve tinnitus, a condition affecting 10% of the adult population and commonly known as 'ringing in the ears'.

Having launched in the States in April 2023 and received FDA approval also it is an exciting time to be part of this team.



Responsibilities:
- Develop comprehensive test protocols for various testing domains including, but not limited to, electronic circuit design verification (DVT), mechanical design verification testing, sound stimulation functional testing, electrical stimulation functional testing, packaging integrity testing, transport validation, ingress protection testing, electromagnetic compatibility testing and wireless coexistence testing.
- Participate in the design change control process, ensuring that any changes made to the product design are verified, validated and meet the requirements of applicable procedures and regulations.
- Participate in the design, development, and validation of manufacturing equipment, particularly focusing on printed-circuit board test fixtures.
- Continuous Improvement, Training and Collaboration


Education, Qualifications and Experience

• Degree in biomedical, electronic, electrical, software, or a similar relevant field with Degree in Engineering or related fields (Electrical, Electronic or Mechanical Engineering preferred) with 5+ years' industry experience in an engineering role.
• An understanding of quality management system principles (e.g., ISO 9001 or ISO 13485) and/or FDA design and development processes to 21 CFR part 820.
• At least one year experience in electrical and/or mechanical verification (Design Verification Testing/ DVT), including the drafting of test protocols, executing or overseeing the execution of testing, and authoring of test reports.
• Relevant experience in medical device design or manufacturing.