Sr R&D Engineer, Advanced Catheter Development

Imperative CareCampbell, CA
1dOnsite

About The Position

As a senior professional, this position will use solid knowledge and experience to design, develop and launch innovative endovascular/neurovascular products through conceptualization, design development, verification/validation, and manufacturability assessments. This role will deliver ideation and prototyping, establishing requirements/specifications and verification of performance inputs and outputs. Serve as technical team member or lead in project transfers from early-stage teams into formal design control programs Create, modify, and qualify test methods per FDA and regulatory requirements Establish and/or tune detailed requirements including product specifications and appropriate test methods through activities such as competitive testing, literature review and KOL engagement Develop complex prototypes and refine designs in response to feasibility testing data, pre-clinical evaluations, and customer feedback Ensure technical activities are properly documented; participate in and contribute to technical discussion sessions to generate new intellectual property.

Requirements

  • Bachelor’s degree in engineering, or related discipline and a minimum of 5 years of related experience in the medical device or related regulated industry; or equivalent combination of education and work experience.
  • Experience in endovascular/neurovascular techniques and devices, with knowledge of relevant standards preferred
  • Demonstrated knowledge of and exposure to product testing and data collection
  • Strong skill detailing project plans effectively with ability to complete projects independently or as part of a team, using evaluation, judgement and interpretation to select course of action
  • Must be able to travel domestically and internationally

Responsibilities

  • Serve as technical team member or lead in project transfers from early-stage teams into formal design control programs
  • Create, modify, and qualify test methods per FDA and regulatory requirements
  • Establish and/or tune detailed requirements including product specifications and appropriate test methods through activities such as competitive testing, literature review and KOL engagement
  • Develop complex prototypes and refine designs in response to feasibility testing data, pre-clinical evaluations, and customer feedback
  • Ensure technical activities are properly documented; participate in and contribute to technical discussion sessions to generate new intellectual property.

Benefits

  • stock options
  • bonus
  • competitive salaries
  • a 401k plan
  • health benefits
  • generous PTO
  • a parental leave program
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