Job Description

Medical Device Experience is a must!   The Principal R&D Engineer will be focusing on the development and support of electrophysiology products at Company, focusing on ablation systems. Works on most assignments with instructions about the general results expected. May receive technical guidance on the most unusual or complex problems, but independently resolves and develops approaches to solutions. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions.   Erroneous decisions or recommendations or failure to get results would normally result in serious program/project delay and considerable expenditure or resources. KEY RESPONSIBILITIES:

• Applies intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields.
• Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work.
• Requires the use of advanced techniques and the modification and extension of theories, precepts and practices of his/her field and related sciences and subject areas.
• Supervision and guidance related largely to overall requirements, critical issues, new concepts and policy matters.
• Consults with supervisor concerning unusual problems and developments.
• Responsible for or more of the following:
• In a supervisory capacity, plans, develops, coordinates and directs a large important engineering project or a number of small projects with many complex features.
• As an individual researcher, carries out complex or novel assignments requiring the development of new or improved techniques or procedures.
• Receiving technical mentorship on complex problems, but independently resolving and developing approaches and solutions. Work is expected to result in the development of new or improved techniques or procedures.
• Work is encouraged to result in the development of new or refined equipment, materials, processes, products, and/or methods.
• Develops and evaluates plans and criteria for a variety of projects and activities to be carried out by others.
• Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment when necessary data are insufficient or confirmation by testing is advisable.
• Performs as a consultant on a technical specialty, a type of facility or equipment, or a program function.
• May technically supervise, coordinate and review the work of a small staff of engineers and technicians, estimates resource needs and schedules and assigns work to meet completion date, or as individual researcher or staff specialist may be assisted on projects by other engineers or technicians.
• Practices company safety and quality policies and procedures. Actively requires conformance.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.
• Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.

  QUALIFICATIONS   EDUCATION:

• A Bachelor’ s Degree in Engineering or equivalent degree is required.

EXPERIENCE AND SKILLS:

• Must have eight (8) plus years of hands on experience in medical device design including technology or product development responsibility along with at least five (5) years of providing technical leadership on cross-functional teams.
• Must have an extensive experience in leading projects.
• Must have experience in development processes and in documentation writing
• Must be familiar with design control, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA) and software version control.
• Knowledge and experience with ablation systems a plus.
• Must possess a clear mastery of theoretical and practical fundamentals and experimental engineering techniques.