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Sr R&D Engineer, Advanced Development

Sr R&D Engineer, Advanced Development

Imperative CareCampbell, CA, US
30+ days ago
Job type
  • Full-time
  • Quick Apply
Job description

Title :

  • Senior R&D Engineer This position is based in our Campbell, California offices.
  • This position is on-site, full-time.
  • Why Imperative Care?
  • Do you want to make a real impact on patients?
  • As part of our team at Imperative Care, you can help elevate care for patients suffering from stroke and other devastating vascular diseases.
  • Every day, the technologies that we develop at Imperative Care directly impact people at the most vulnerable moments of their lives.
  • Our focus is on the needs of the patient, and they come first in everything we do.
  • What You’ll Do As a senior professional, t his 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 on early-stage projects through project transfer to larger cross-functional teams and into formal design control programs, executing projects based on value improvement, line extensions, and compliance on commercialized products.
  • Respond to technical field inquiries and perform root-cause investigations on product failures.
  • 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.
  • Create and execute product test plans for verification and validation of specifications using novel bench testing, model / fixture development, test method validation and ex / in vivo testing (as required).
  • Develop complex prototypes and refine designs in response to feasibility testing data, pre-clinical evaluations, and customer inputs.
  • Author robust component / assembly drawings, specification documents, test protocols and reports.
  • Ensure technical activities are properly documented; participate in and contribute to technical discussion sessions to generate new intellectual property.
  • Perform design control activities for new product development including performing comprehensive design evaluation, contributing to risk analyses (Hazards / Harms, FMEAs etc.) and ensuring documentation is in accordance with Quality System requirements.
  • Ensure that new products, components, and assemblies are designed to facilitate manufacturability.
  • May contribute to the process of transferring product from development to manufacturing including fixture / tooling development and Manufacturing Process Instruction review.

What You’ll Bring :

  • 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.
  • Demonstrated experience of full R&D product life cycle and product design from concept to regulatory marketing approval.
  • MS in Engineering and experience in endovascular / neurovascular techniques and devices, with knowledge of relevant standards preferred.
  • Statistical analysis Software (Minitab or similar) and CAD (Solidworks, ProE, similar).
  • 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.
  • Experience working under regulated quality systems such as GMPs, ISO 13485 / 9001, and the MDD.
  • Familiar with Design Control procedures and requirements.
  • Excellent written and verbal communication skills required.
  • Must be able to travel domestically and internationally.
  • Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.
  • Join Us!
  • Imperative Care Salary Range :

  • $129,000 – 142,000 annually Please note that the salary information is a general guideline only.
  • Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education / training, key skills, and internal equity, as well as location, market and business considerations when extending an offer.  As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources.   The use of external recruiters / staffing agencies requires prior approval from our Human Resources Department.
  • The Human Resources Department at Imperative Care requests that external recruiters / staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates.
  • Complying with this request will be a factor in determining future professional relationships with Imperative Care.
  • Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.
  • Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter / staffing agency does not create any implied obligation on the part of Imperative Care.
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    Development Engineer • Campbell, CA, US

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