Optizm Global

Job Summary:

• This role will support the design and development effort for new products using Phase Gate PDP development process in compliance with Quality Management System.

Roles & Responsibilities:

• Conceptualize and prototype new devices using knowledge of materials and processes as well as creativity to create innovative mechanical designs.
• Collaborate with physician users to develop relevant simulated use models and test and iterate on prototypes.
• Plan, coordinate, and execute activity in support of Product Development Process. Identify and mitigate project risks and escalate in timely manner.
• Quickly iterate on designs until they meet product requirements and specifications
• Lead verification and validation testing in support of regulatory clearance and support animal testing and clinical evaluations.
• Participate the Phase gate reviews in support of PDP processes for new product development.
• Keep up to date knowledge of the developing clinical environment (i.e. current treatment methods, competitive devices, evolving clinical needs etc.)
• Work with outside consultants, vendors, and the medical community
• Generate intellectual property
• May manage and supervise technicians, co-ops/interns.
• Ensure compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, and company processes.

Qualification, Skills and Experience:

• Masters or bachelor’s in Biomedical, Mechanical or Material Science Engineering
• Minimum 8 years’ experience in medical device product development on Class II and Class III devices.
• Knowledge of medical device product development processes including risk management and FDA regulations.
• Strong verbal and written communications with ability to effectively communicate within the organization, external vendor and partners.
• Project management skills & Project leadership
• Experience with modeling tools namely SolidWorks
• Experience with statistical analysis tool namely Minitab
• Experience with a variety of manufacturing processes and design for manufacturability of interventional medical devices
• Experience with development of testing methods for interventional devices and simulated clinically relevant models.