Engineer

Responsible for: 

• Resolves competing constraints between interrelated functions (engineering, purchasing, manufacturing, regulatory, marketing, etc.) required to deliver the product to market.
• Defines protocols and conduct the necessary testing required to validate the safety and effectiveness of the design(s).
• Develops and maintains an effective and corroborative working relationship with internal and external development partners.
• Executes protocols and testing required to validate the safety and effectiveness of the design(s).
• Troubleshooting and problem solving efforts related to mechanical aspects of devices and associated systems/subsystems.
• Creates and communicates design/test plans, tasks, deliverables and status. Manages time and resources to meet committed schedule milestones.
• A demonstrated track record in Plastic component Design, preferably medical devices or other highly regulated products.
• In depth knowledge of the regulatory environment for Design, Develop and Manufacture of Medical products.
• Knowledge of machinery to build prototypes, handle variety of materials for prototypes and testing (metals, plastics, films, etc.), set up engineering tests to validate new products and processes
• Demonstrated record of working with multiple vendors and suppliers.
• Knowledge of standards such as IEC 60601, UL, ANSI, ASTM standards.
• Experience working with regulatory bodies like UL, TuV, ITT
• Understanding of the Healthcare regulatory environment and country regulations
• Demonstrated strong analytical and problem solving skills
• Excellent verbal and written communication skills
• Success in working with multifunctional, global teams.
• Excellent interpersonal/communication/influencing skills required