Product Development Engineer
We are recruiting for a Product Development Engineer to join our team at a growing medical devices company. This engineering role will focus on the design, development, and optimization of medical devices aimed at improving the lives of individuals with tinnitus.
Main 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.
Requirements:
* Engineering degree with a minimum of 5 years of experience in product development engineering, preferably in medical devices or related fields.
* 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.
* 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.
Desirable Skills:
* Global perspective with the ability to work effectively in multi-disciplinary teams.
* Continuous improvement mindset & experience including Six Sigma/Lean Manufacturing.
* Strong attention to detail and commitment to quality.
* Ability to train and mentor other team members and guide them to resolutions.