This NEW engineering position requires strong technical skills and an ability to support and lead the design and development of innovative, new products.
- Required - BS in Mechanical Engineering, Biomedical Engineering or similar with 5+ years of design and development experience.
- Preferred - MS or PhD in Mechanical Engineering, Biomedical Engineering or similar with 2+ years of design and development experience.
- Be creative and apply solid mechanicalengineering design skills while following design controls to develop new medical devices.
- Develop concepts and build prototypes for marketing, user feedback, technical feasibility of device functionality, design for manufacturing and design for assembly.
- Contribute as the R&D team member to complete various project activities - development of design inputs from user needs, generate concepts, evaluate feasibility, generate FMEAs, assist with risk analysis, and perform design verification and validation, assist in design transfer and setting up manufacturing processes.
- Create and implement the product test plans/protocols and generate test reports to ensure product design meets the specifications and quality system requirements.
- Make, recommend or justify critical technical decisions based on scientific investigation and testing in product design and ensure their implementation in development.
- Work closely with cross-functional team, including design reviews with manufacturing engineers, test engineers, electrical engineers to ensure the design meets the product requirements, including safety, reliability and manufacturability. Be creative in finding cost effective and innovative solutions in the product development process.
- Work closely with supply chain, contract manufacturers, vendors and suppliers to ensure quality goals are met.
- Familiarity with medical device regulatory environment including FDA regulations and guidance such as QSR, GMP, Usability.
- Able to work in global collaborating environment with intensive challenges.
- About 10% travel involved.
Reference # 8121