Aug 06, 2021

R&D Project Lead

  • Ontogen Medtech
  • Lisle, IL, USA
Full time Biotech Design Engineering Research

Job Description

R&D Project Lead

 

Ontogen MedTech seeks an R&D Project Lead to join its product development team to lead the development of innovative medical device products in Chicagoland, IL.  This person will be adept at all aspects of medical device development from concept to launch and capable of owning and managing complex development projects and cross-functional / cross-organizational teams.  Responsibilities may include preparing and presenting project proposals to clients, product conceptualization and design, intellectual property development, DHF documentation preparation, drafting and executing test protocols, conducting prototype tests, gathering and organizing test data, regulatory submission preparation, writing test reports, documenting official procedures, design and creation of new test methods and fixtures, hands-on prototype fabrication, frequent interaction with vendors and suppliers to ensure timely completion of deliverables, and any other responsibilities assigned by Management. 

 

At minimum, candidates will have:

  • BS in Mechanical Engineering, Biomedical Engineering or equivalent
  • 10+ years Medical Device R&D experience
  • Experience with medical device development and FDA quality practices and standards, including ISO 13485;
  • Demonstrated ability to work independently with minimal supervision
  • Demonstrated leadership abilities and qualities
  • Excellent oral and written communication skills, particularly in technical writing and documentation
  • Demonstrated organizational, interpersonal, and critical thinking skills

 

Additionally, the following are highly desirable:  

  • MS in Mechanical Engineering, Biomedical Engineering or equivalent
  • Prior experience working in a fast-paced med tech startup environment
  • Prior experience in technical interaction with the FDA, both written and verbal presentation
  • Demonstrated expertise with risk management per ISO 14971
  • Direct experience with biocompatibility requirements and testing per ISO 10993
  • Direct experience with sterile packaging requirements and testing per ISO 11607
  • Direct experience with sterilization requirements and testing per ISO 11135
  • Direct experience with usability requirements and testing per FDA guidance
  • Demonstrated understanding and experience with common medical device packaging materials and techniques, sterilization processes and techniques, sterilization validation, etc.

 

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the U.S. and to complete the required verification document upon hire. 

 


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