Title: Product Development Engineer
Location: The Digital Hub, Dublin 8. (Hybrid working)


Company: My client are a venture-backed Irish medical device developer of a neuromodulation-based treatment of tinnitus, a debilitating condition commonly known as ‘ringing in the ears’. With one product on the market in America and Europe they are now looking at next Gen products and looking to grow in the market.


Job Description: My client are seeking a highly skilled and motivated Product Development Engineer to join our team. This engineering role will focus on the design, development, and optimization of medical devices aimed at improving the lives of individuals with tinnitus. You will work closely with cross-functional teams, to ensure the successful execution of product development deliverables.


Responsibilities:

• Lead product development activities from design and prototyping to testing, validation, and commercialization for tinnitus treatment devices, including both hardware and software components.
• Collaborate cross-functionally with Operations, QA/RA, Technical Support, and Commercial teams to ensure smooth product development and compliance with industry standards.
• Partner with the Product Manager to define product strategies and requirements, ensuring alignment with business goals and market needs.
• Define technical requirements, conduct feasibility studies, and develop design inputs for new products.
• Work on embedded systems, firmware, and software development to ensure seamless integration into the medical device.
• Perform risk assessments and contribute to the creation of product development documentation, including design history files (DHF) and technical files.
• Work closely with product development and manufacturing teams to ensure designs are optimized for production and scalability.
• Manage the product development lifecycle to ensure timelines are met and products are developed to meet regulatory requirements and quality standards.
• Participate in design reviews, prototype testing, and provide technical support to other departments throughout the product lifecycle.
• Assist in troubleshooting and providing technical solutions for product-related issues in both development and post-market stages.

• Engineering degree with a minimum of 3 years of experience in product development engineering, preferably in medical devices or related fields (e.g. hearing technology or similar industries)
• Strong experience in embedded systems, firmware, and software development for medical devices.
• Experience in developing and launching medical devices, with a strong understanding of design controls and regulatory requirements (e.g., FDA, ISO 13485).
• Hands-on experience in product design, prototyping, and testing, including both hardware and software components.
• Strong knowledge of mechanical engineering principles, materials, and manufacturing processes, along with software development principles.
• Familiarity with risk management techniques (e.g., FMEA) and product validation processes.