Development Engineer - Medical Device
We’re seeking a technical expert who would be responsible for new product development for medical devices. Candidate will develop requirement specifications and lead performance quality, scheduling as well as budgeting.
ESSENTIAL DUTIES & RESPONSIBILITIES
•Develops design solutions to complex technical problems where analysis of data requires an in-depth evaluation of many factors. Solutions require use of ingenuity and creativity.
•Design and develop new medical products to meet customer requirements within scope
•Represent the company in initial technical reviews and cost estimation analysis of new products to support quote generation.
•Translate customer’s product requirements into achievable product specifications and design features.
•Represent the company in FMEA and risk analysis reviews on development products as well as a series of cross-functional design reviews throughout the development process.
•Direct proof-of-concept and design verification testing and write final test reports for communication with internal and external customers.
•Ensure new designs meet relevant environmental and regulatory Design History File (DHF) requirements.
•BS in Engineering (Mechanical or Electrical preferred) with 5 or more years of related product design and development engineering experience
•Medical product development experience and knowledge of FDA regulations.
•Proven technical contribution through creative product design solutions that have been successfully launched into the market.
•Demonstrated inventiveness through invention disclosures, patents, active participation in professional organizations, technical conference presentations, etc.
•Advanced knowledge of materials, manufacturing processes (e.g., plastic injection molding, machining, automated assembly), sterilization, and advanced statistical techniques.
•Demonstrated aptitude of innovative mechanical and design skills including but not limited to frequent use of 2D and 3D SolidWorks modeling and prototype creation.
•Effective problem solving and project management skills.
•Ability to effectively manage and motivate others to meet deadlines.
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