Sr R&D Engineer

Imperative Care • Campbell, CA

89d • $129,000 - $142,000

About The Position

This position is based in our Campbell, California offices. This position is on-site, full-time. 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.

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.
• 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.
• 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.

Nice To Haves

• Experience in endovascular/neurovascular techniques and devices.
• Knowledge of relevant standards.

Responsibilities

• Design, develop and launch innovative endovascular/neurovascular products through conceptualization, design development, verification/validation, and manufacturability assessments.
• 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.
• 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.
• 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.
• 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 and contributing to risk analyses.
• Ensure that new products, components, and assemblies are designed to facilitate manufacturability.

Benefits

• Stock options
• Competitive salaries
• 401k plan
• Health benefits
• Generous PTO
• Parental leave program
• Emotional health resources

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 251-500 employees