Principal R&D Engineer

Website 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.

To apply for this job email your details to ranjan@optizmglobal.com

Anshuman Sinha

I am an Entrepreneur and Angel Investor. Board Member of TiE SoCal Angels Fund, and CEO @ Optizm Global, the executive search firm. We are a Right Fit Recruitment & Placement Agency.

I'm the Co-Founder of "StartupSteroid" the platform to connect founders with investors.

As an Angel Investor I look for Business Plan, Cashflow, Core Team, Board of Advisors, Secure IP, Quality Investors, Monetization Models, USP, Scalability, Strong Returns, Growth Market, and Board Role.