R&D Project Manager

Reference Number: 471
Location: NC

R&D Project Manager

If you don’t like the thrill of a rollercoaster ride, you probably shouldn’t read any further.  Start-ups are innately scary because they are a risk.  And it isn’t an indictment but there aren’t many experienced engineers with a high risk personality.  Why is this risk any different than any other start-up?  On its surface it probably isn’t but when you drill deeper you will see that the most important qualifier of a successful start-up is intrinsic to this device; it is not a me too!  It isn’t about trying to improve, with little change to the approach, the condition of an existing product.  It is neither a sequel nor a remake.  No, in this instance it’s about completely shifting the paradigm in a way that will have a significant, positive impact on patient outcome. 

Scared but interested?  Good. 

Here’s the other thing though; this is the central R&D engineering role and while there’s a bit of a supporting cast you will be the one in the limelight.  You must have implantable device experience; you must have a minimum of a 4 year degree in engineering but an MS would be a plus; and you need a minimum of 5 years of demonstrable success in product design.  The following requirements will be intimidating to many but if they aren’t so to you, and if you’re really looking for that opportunity of a lifetime to make a difference we really should talk. 

Responsibilities:

  • Apply broad engineering knowledge to the design and development of new products as well as product changes and enhancements which are consistent with a zero-defect level as well as low product cost 
  • Conduct testing utilizing existing test protocols or develop new ones as needed
  • Assign work to vendors, technicians and temporary workers as needed  
  • Complete projects (including product enhancements) in a manner consistent with corporate objectives 
  • Contribute to the intellectual property position of the company via invention and patent applications 
  • Maintain accurate documentation of concepts, designs, drawings, and processes
  • Maintain current knowledge of procedure technologies in addition to medical, technical, and biomedical developments related to company products  
  • Provide multidisciplinary engineering and technical support of products introduced into both the domestic and international markets as well as physician in-service programs
  • Oversee outside vendors and consultants as required
  • Develop and maintain QMS systems
  • Provide multidisciplinary engineering support in the resolution of product complaints and/or safety issues 
  • Work with other engineering, manufacturing, clinical affairs, sales and marketing, and quality assurance staff to coordinate production of new products  
  • Support company goals and objectives, follow policies and procedures, adhere to Good Manufacturing Practices, and meet FDA regulations

 

Requirements: 

  • BSME and a minimum of 5 years of experience
  • Class 3 Implantable device experience preferred
  • Familiarity with interventional products used within the cardiovascular system
  • Field experience in clinical procedure setting desired
  • Strong project management skills from concept to clinical study
  • Experience in surgical procedures and managing physician relationships
  • Ability to coordinate and lead development programs in accordance with FDA and QMS requirements
  • Working knowledge and demonstrated ability with CAD software, SolidWorks preferred, including hardware and software performance requirements and configurations

 

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