R&D Manager, Medical Device

Reference Number: 475
Location: TX

Research & Development Manager

Organic growth of 10-20% per year in a small to medium sized company is the very definition of exciting.   It’s that situation where you are constantly testing your own limits as well as the limits of those who work for you.  It’s the rare opportunity to learn every critical cog in the business wheel because at some point you’ll probably do that job. 

What do you need to bring?  Electrical Engineering skills that have been plied in a Medical Device role for at least 8 years as a doer and at least 3 of those need to be in a supervisory/managerial role where you coached others to successful conclusions.  Yes, you also need to be familiar with that laundry list of standards like IEC 60601-1, ISO 13485, ISO 14971 but as importantly, bring your “can-do” attitude. 

What is most rare about this opportunity is, as the R&D Manager, your legacy will become the company’s legacy.  There’s a team in place and they are hungry for mentoring.  There are products in the pipeline wringing their hands as they wait for the right leadership.  And yes, there are customers who know, as good as the current products are, the next gen will be even better.  Sound interesting? 


  • Hands-on as well as mentoring accountability for the development of a microelectromechanical system
  • Describe/defines project requirements (i.e. Microsoft Project) including costs and resources, providing regular updates to the team, the peer group and management
  • Within the limits of the QS and ensuring compliance with FDA and other authorities, ensures that the Design Control system is a living document current with the business circumstance and regulatory requirements
  • Works directly with clientele to integrate the product line to theirs as well as to develop internal (private labeled) devices especially as regards the systems’ electronics
  • Hires, on-boards, develops, directs, coaches and leads the R&D group providing the leadership required to ensure success from the individual and the organization
  • Embraces the hands-on component of being a EE leading her/his group by example but providing the teaching needed for succession planning
  • Maintains an appropriate relationship with RA/QA to maintain compliance through documentation as well as assure the company’s IP is appropriately guarded
  • Has final signatory authority and accountability for all documents from DHF fulfillment to EC notices
  • May participate in patent and/or grant application writing
  • Leads cross-functional efforts in development and manufacturing transfer to ensure patient safety and product efficacy


  • Minimum of a Bachelor’s Degree in Engineering either Electrical or with a strong focus to electrical engineering; Master’s degree preferred 
  • A minimum of 8 years’ experience in Medical Device R&D where at least 2 of those are in a Supervisory or Managerial capacity
  • Highly knowledgeable in applicable IEC & ISO (e.g. 60601-1, 13485, 14971) standards and applicable regulations both domestic and international
  • Demonstrable experience with Design Control and documentation
  • Embraces a hands-on management approach and has clear skills with engineering techniques and electronic assembly procedures that may include basics like soldering and bread-boarding
  • Defines, writes protocols, collects data, analyzes and presents the results of experiments that prove efficacy
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