Job Description
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, 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 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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