Assoc Dir Product Development, Medical Device

Texas | Engineering
  • Texas

Associate Director of Product Development

 

Our client is a Medical Device start-up engaged in an extraordinary clinical challenge, developing a truly unique product in a cardiac related clinical need with little competition.  If you know the Device space, here’s the allure; to-date results not only offer a solution to the clinician, but also dramatically reduce the cost to treat this patient population.  And the device already has reimbursement codes.  Are you still reading or did you stop at start-up?  If you are still reading, you understand that the title is not for someone looking for the next notch on their career belt, rather it’s an indication of the desired experience level.  Make no mistake, while this job demands your skills in persuasion, your hands-on skills need to be fresh and in tune with current technology. 

 

This role will drive critical mechanical components of the device implant and requires the qualified candidate to have discernable experience with NiTi.  The components interact directly with the implant, the power leads, and the delivery system so you need to understand how the material reacts for its purpose (e.g FEA) and how it will interact with the other pieces of the puzzle.  You need a med device background because your contribution to the Design Control and/or DHF will be critical.  Oh, and if the message wasn’t clear, your persuasive skills will be needed with technicians, peers, vendors and most importantly the PhD’s who were part of the original concept. 

 

RESPONSIBILITIES: 

  • Champions the development or enhancement of the company’s products to achieve customer input ensuring requirements are met and Design Control is implemented throughout the process
  • Leads Design Review process, regularly assessing and reporting status from concept to commercialization
  • Accountable for design conformity to engineering principles, regulatory requirements, company procedures, and customer requirements/specifications
  • Responsible for project strategy, task implementation, and organizing staff to meet company objectives
  • Ensures the effective integration of their sphere of influence cross-functionally with marketing, regulatory, quality, and clinical and others as needed
  • Regularly interacts with all levels of Senior management to review/set project goals and priorities
  • Overall responsibilities include coordination of technical/development activities, scheduling, testing procedures, and design change approval and re-testing
  • Contributes to budget requirements and subsequently controls costs within the project’s scope
  • Writes test protocols, performs or oversees tests, documents results, and writes reports
  • Prepares protocols and reports, initiating or participating in animal studies
  • Signatory for Design and Process Freeze

REQUIREMENTS:

  1. BS in an Engineering Discipline (MS a plus) with strong, hands-on engineering skills
  2. 5 to 10 years’ experience in device development with strong materials knowledge (background in cardio a plus)
  3. SolidWorks a must (FEA in nitinol a plus)
  4. Soft skills must include influencing others, effective interpersonal interaction, systemic thinking and problem-solving
  5. Experienced in the requirements of ISO 13485, 21 CFR 820, EU CE, and others regarding reports and data
  6. Skilled in tools like MS Office and Project
  7. Proficient in the use of the English language
  8. Must be able to sit/stand/walk 8 hours per day
  9. Position requires up to 10% travel which includes air travel
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