Website Optizm Global
- 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.
To apply for this job email your details to email@example.com