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R&D Catheter Engineer

R&D Catheter Engineer

Bolt MedicalCarlsbad, CA, US
23 hours ago
Job type
  • Full-time
Job description

Job Description

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS : DO NOT CONTACT.

Overview :

Position Overview : Catheter R&D Engineer will be a key contributor to the design and development of next generation Intravascular Lithotripsy (IVL) devices. Contribute as part of a cross‐functional team in product design and development, process development and optimization, and testing to support new product development.

Responsibilities :

  • Provide technical leadership for projects in the coronary vascular space.
  • Provide mentorship to other engineers and assignments to technicians as required.
  • Collaborate cross-functionally to gather and define user needs for new products
  • Prototype and develop proof of concept designs, disease models and test methods based on the defined user needs and requirements.
  • Solve challenging and complex technical problems during the new product development process.
  • Work with clinical and scientific advisors as well as Key Opinion Leaders in translating clinical needs into design solutions while utilizing these resources to develop and optimize product design.
  • Analyze, evaluate, source, and coordinate the procurement of new materials to support prototyping and pilot operation.
  • Develop protocols, test methods, and reports, and perform product assessments on benchtop, in-situ, and in-vivo to prove and de-risk viability and feasibility of new product designs.
  • Identify suppliers and maintain relationships to ensure the delivery of superior components and services.
  • Enhance the intellectual property position of the company via invention disclosures and patent applications.
  • Participate as SME on product development team(s) that manage projects from concept through transfer to PDP team.
  • Design and develop product(s) in compliance with the company’s Design Control requirements and consistent with applicable regulatory requirements.
  • Ensure proper documentation consistent with the company’s quality system.
  • Responsible for knowing and planning activities consistent with the company’s quality policy and quality objectives.
  • Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company’s products.
  • Responsible for component and assembly documentation for new products being developed.
  • Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations.
  • Other duties as assigned.

Qualifications :

  • Bachelor’s Degree in Mechanical or Biomedical (or similar) Engineering and minimum 5 years’ experience in engineering OR a Master’s Degree / PhD and 3 years’ experience in engineering
  • 3 years experience in early-stage (pre-design freeze) catheter and / or leads-based cardiovascular device development, preferred.
  • Knowledge of coronary and vascular anatomy, physiology, and model development is a strong plus.
  • Minimum 1 year as team or project technical lead.
  • Strong understanding of engineering materials, component selection, and design for reliability and manufacturability.
  • Strong understanding of data analysis and statistics including design of experiments, Gage R&R, capability, etc. is a strong plus.
  • Strong teamwork skills and demonstrated ability to work closely with cross functional partners.
  • Effective communication skills with all levels of management and organizations.
  • Operate independently and adaptability to changing requirements.
  • Ability to work in a fast-paced environment, managing multiple priorities.
  • Occasional travel up to 10%
  • Employee may be required to lift objects up to 25 lbs.
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    Engineer • Carlsbad, CA, US