Position Title: Product Development Engineer
Reports to: R&D Head
About this Role:
- The Product Development Engineer will bring design and drafting competencies into the Product Development Lifecycle from the early concept stage to the product release stage.
This person will work on new, exciting products and technology using state of the art equipment while focusing on product design and problem solving as well as engineering documentation.
Main Purpose & Key Accountabilities:
- Responsible for end to end development of product, from capturing the user/marketing needs to final product release.
- Interact with customers and marketing team to develop and refine user requirements
- The Product Development Engineer plays a pivotal role in product development, making sure the product meets all the functional and the performance requirements.
- Responsible to ensure that the manufacturing requirements are translated into product design.
- Develop the Risk Management Plan and execute the Risk Management activities defined by the plan
- Develop and delivers the reliability goals of the product
- Develop and delivers the regulatory compliance requirement in product design
- Plan and execute system integration activities to minimize issues in verification and validation
- Develop test plans, test protocols, and test reports for product integration testing
- Document traceability from requirements to verification activities, and from requirements to design entities.
- Summarizes results, contributes to the generation of technical reports, and completes experimental paperwork/lab notebook documentation.
- Tolerance Analysis
- Assist with Illustrations and Presentations
- Comply with Medorah’s reporting policies and procedures
- High ethical & performance standards, discretion / confidentiality
- Strong analytical skills and demonstrated ability to collaborate
- Written & oral communication and presentation skills
- Entrepreneurial bent of mind and a self-starter who is able to function independently with minimal direct supervision; with a “can do” attitude
- Excellent and proven problem-solving capabilities.
- Customer focus and concern for impact
Experience and Knowledge:
- In-depth knowledge of the regulatory environment for design, develop and manufacture of medical devices
- Excellent computer and systems skills – Excel, MS office, Power Point etc.
- Bachelor/Master’s degree in Mechanical Engineering, Biomedical Engineering or equivalent
- Minimum of 3 years of experience in product development or related field
- Familiarity with ISO, FDA and other regulatory standards