Sr Clinical Engineer

imperativecare; Campbell (CA); On-site; USD 140,000 - 150,000; Full time

Benefits offered by this job

Stock options

401k plan

Health benefits

Generous PTO

Parental leave

Job summary

Imperative Care is hiring a Sr Clinical Engineer for our Campbell, CA office. This on-site, full-time role focuses on gathering clinical data to define and test vascular and stroke products, with heavy interaction with clinicians and cross-functional teams.

You will lead pre-clinical testing, develop verification plans, and ensure adherence to regulatory standards. The ideal candidate has a BS in Engineering or related field and 5+ years in medical device development, especially in vascular or

Qualifications

• Bachelor's degree in Engineering or related discipline; 5+ years in medical device product development.
• Experience in vascular/neurovascular interventions or surgical robotics.
• Familiarity with FDA QSR, ISO 13485 and regulatory requirements.
• Knowledge of design controls and documentation standards.
• Excellent written and verbal communication; ability to travel as needed.

Responsibilities

• Gather clinical/user data to define and test vascular and stroke products.
• Lead pre-clinical testing, bench testing, and in-vivo studies with teams.
• Create and execute design verification/testing plans and reports.
• Ensure compliance with QMS and regulatory requirements across development.
• Interact with clinical customers and cross-functional partners to capture inputs.
• Support training, onboarding of new team members, and lab maintenance.

Skills

Clinical engineering

Cross-functional collaboration

Communication

Initiative

Independent work

Education

Bachelor's degree in Engineering or related field

Job description

Title: Sr Clinical Engineer

This position is based in our Campbell, California offices. This position is on-site and 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 seasoned professional in this field, the Sr Clinical Engineer is responsible for gathering clinical or user data to inform the definition, specification, design and testing of pre-commercial and commercial vascular and/or stroke products, with heavy emphasis on our stroke portfolio. This team member will interact directly with clinical customers as well as with cross functional internal teams. They must possess significant initiative and be intellectually disposed toward exploring and making sense of the unknown and lead the support of pre-clinical testing, training and support in clinical procedures for internal and external stakeholders using the product(s).

• Serve as a clinical engineering team member for product development including preclinical testing, bench testing, model development needs, in-vitro test methods and plans and in-vivo animal studies.

• Provide updates to team members and management (as needed) regarding project status, and critical issues that may affect attainment of project completion dates.
• Create and execute design verification and testing plans, participating in team meetings where progress is discussed, decisions are made, and updates are communicated.
• Ensure work effort supports pre-clinical testing of new products within the design control and applicable quality standards, and products are designed, developed, tested, manufactured and documented according to applicable global regulatory requirements.
• Support new team members or interns though product and procedure training as needed
• Ensure detailed plans are executed fully to support internal development projects with preclinical testing including bench testing, model development needs, in-vitro test methods and plans and in-vivo animal studies.
• Interact directly with clinical customers to identify customer input requirements for the system
• Plan and conduct ethnography studies
• Interact directly with commercial and marketing partners to identify gaps and potential solutions to existing customer needs
• Provide inputs to help quantify performance requirements for our products
• Work with design engineers to translate customer input requirements to design input requirements
• Drive completion of pre-clinical testing including validation testing
• Develop test models
• Create test plans, protocols, reports for all testing ensuring all documentation is aligned to company procedures and QMS
• Responsible for planning, conducting and completing lab activities including maintaining inventory, ordering materials, setting up and keeping lab areas clean
• Handle complaints and market claims as requested
• Support commercial events such as conferences by providing product demos or physician engagements

What You’ll Bring

• BS in Engineering or related discipline or equivalent and 5+ years of experience with increasing responsibility in novel product or procedure development in the medical device industry or equivalent combination of education and experience
• Experience in one of the following fields: vascular/neurovascular interventions or surgical robotics
• Demonstrated ability to take initiative to start projects, create and meet deadlines.
• Demonstrated success working with cross functional teams and customers (physicians and hospital staff)
• Previous involvement in at least one full product development cycle
• Knowledge of and exposure to product testing and data collection
• Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485 and the MDD
• Strong working knowledge of relevant regulatory standards that apply to the specific product/project
• Familiarity with Design control procedures and requirements
• Excellent communication skills (both written and verbal)
• Ability to work independently or in a team setting required and ability to travel as required for the role;

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: $140,000 – 150,000 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.