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Product Development Engineer
3 weeks ago
We are seeking a highly skilled Product Development Engineer to join our team. This role will focus on the design, development, and optimization of medical devices aimed at improving the lives of individuals with tinnitus.
The successful candidate will lead product development activities from design and prototyping to testing, validation, and commercialization for tinnitus treatment devices, including both hardware and software components.
About the Role:
This is a challenging opportunity for an experienced engineer who can work closely with cross-functional teams to ensure smooth product development and compliance with industry standards.
The ideal candidate will have a strong understanding of mechanical engineering principles, materials, and manufacturing processes, as well as software development principles.
Responsibilities:
- Lead product development activities from design and prototyping to testing, validation, and commercialization for tinnitus treatment devices.
- 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.
Requirements:
- Bachelor's degree in engineering or related field.
- Minimum 5 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.
What We Offer:
We offer a dynamic and fast-paced environment where you can grow your skills and expertise. If you are a motivated and results-driven individual who is passionate about medical devices, we would like to hear from you.
