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Principal R&D Engineering - Exploratory

Principal R&D Engineering - Exploratory

Bolt MedicalCarlsbad, CA, United States
7 hours ago
Job type
  • Full-time
Job description

Position Overview :

The Engineer will be a key contributor for early stage medical device development (Exploratory Programs). The Engineer will work closely with a small team to create and explore new ideas to solve unmet medical device needs.

The ideal candidate will possess deep knowledge across a wide span of cardiovascular therapies, catheters, and accessories used in cases. Experience with development of balloon catheters (i.e., PTA, PTCA) cardiovascular medical devices is required.

Responsibilities :

  • Utilize research and experience to develop new technologies to improve therapies of medical devices.
  • Manage multiple projects simultaneously, on time, well documented and within budget to meet business objectives.
  • Work independently to develop high value IP to solve unmet medical device needs for existing or new therapies.
  • Collaborate with external suppliers for components and identify outsourcing opportunities to accelerate early development cycles.
  • Understand the technology and key product features that ensure clinical and commercial success.
  • Manage research and development activities for exploratory phase of a project.
  • Make data driven decisions using appropriate analytical methodologies
  • Prepare for and conduct various exploratory concept reviews.
  • Demonstrate deep insight regarding design intent and use insight to drive value added early-stage design ideas.
  • Working with highly skilled technicians, develop processes necessary to fabricate devices.
  • Develop and implement new test methods to assess performance characteristics of designs.
  • Prepare documentation to support design transfer for early development teams. (IP, concept documents, test results, drawings, etc.)
  • Provide technical leadership along with technical subject matter expertise to technology development team during exploratory design transfer.
  • Research and recommend material choices for product designs.
  • Translate highly technical results into easily understood recommendations that will influence cross-functional and senior stakeholders.
  • Utilize research and experience to develop new technologies to improve therapies of medical devices.
  • Manage multiple projects simultaneously, on time, well documented and within budget to meet business objectives.
  • Work independently to develop high value IP to solve unmet medical device needs for existing or new therapies.
  • Collaborate with external suppliers for components and identify outsourcing opportunities to accelerate early development cycles.
  • Understand the technology and key product features that ensure clinical and commercial success.
  • Manage research and development activities for exploratory phase of a project.
  • Make data driven decisions using appropriate analytical methodologies
  • Prepare for and conduct various exploratory concept reviews.
  • Demonstrate deep insight regarding design intent and use insight to drive value added early-stage design ideas.
  • Working with highly skilled technicians, develop processes necessary to fabricate devices.
  • Develop and implement new test methods to assess performance characteristics of designs.
  • Prepare documentation to support design transfer for early development teams. (IP, concept documents, test results, drawings, etc.)
  • Provide technical leadership along with technical subject matter expertise to technology development team during exploratory design transfer.
  • Research and recommend material choices for product designs.
  • Translate highly technical results into easily understood recommendations that will influence cross-functional and senior stakeholders.

Qualifications : Education :

  • BS degree in Engineering, Biomedical or Physics
  • Minimum Required Experience :
  • Minimum of 15 years of experience in medical device engineering.
  • Proven track record of developing medical devices from concept to design transfer that have made it to market.
  • Generated core IP and patents related to commercial medical devices.
  • Proficient in CAD software, preferably SolidWorks.
  • Experience with mechanical and / or electrical design, mechanical / electrical drawings, tolerance analysis, and computer-aided design (CAD)
  • Excellent hands-on mechanical prototyping, verification, and failure analysis skills.
  • Proven self-starter who runs towards critical issues, ambiguous requirements, or loosely defined challenges with a demonstrated ability to rally teams to achieve business results.
  • Preferred Experience

  • MS / PHD in Engineering, Biomedical or Physics
  • Polymer knowledge along with extrusion, injection molding experience and metallurgy.
  • Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD
  • Working knowledge of mechanical design principles.
  • Experience developing FDA class 3 medical devices.
  • Medical Device experience in new product development with successful design from concept to commercialization is strongly preferred.
  • Familiarity with statistical analysis of raw data is required, proficiency in Minitab is preferred.
  • Knowledge of ASME Y14.5 GD&T.
  • A flexible team player, focusing on shared goals with a positive results oriented attitude.
  • Strong leadership skills and mentoring capabilities
  • Strong interpersonal and communication skills (oral / presentation and written
  • Strong quantitative analysis and problem-solving skills and methodologies
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