Principal Clinical Engineer

imperativecare; Campbell (CA); On-site; USD 188,000 - 220,000; Full time

Benefits offered by this job

Stock options

Performance bonus

401(k) plan

Health benefits

Generous PTO

Parental leave

Job summary

Imperative Care in Campbell, California seeks a Principal Clinical Engineer to drive design verification, preclinical testing, and regulatory aligned development of neurovascular devices. You will lead cross-functional teams, manage budgets, and mentor junior staff while ensuring usability for physicians.

You must have a mechanical or biomedical background with 12+ years in medical devices, ISO 13485 proficiency, and experience with MDRs/IDE/PMAs.

Qualifications

• Bachelor's degree in mechanical or biomedical engineering with 12+ years in medical devices.
• Experience leading clinical/technical innovation projects and usability assessment.
• Expertise in ISO 13485 and interpreting QSR, MDR, IDE, PMA guidance.
• Ability to travel 15–20% and manage cross‑functional teams.

Responsibilities

• Establish project plans for preclinical testing, bench tests, model development, in‑vitro methods, and in‑vivo studies.
• Oversee budget spending for preclinical projects and allocate resources for testing capabilities.
• Contribute to strategies for clinical use of products and align with company objectives.
• Collaborate with internal and external multidisciplinary teams to address issues and communicate progress.
• Provide management updates on project status and revise tactical plans as needed.
• Create and execute design verification and testing plans; lead team meetings.
• Ensure compliance with design control and global regulatory requirements for products.
• Participate in hiring, training, and performance management of staff.
• Stay current on high-quality preclinical testing capabilities.

Skills

Clinical engineering

Medical device development

Preclinical testing

Regulatory compliance

Team leadership

Budget management

Regulatory submissions

Education

Bachelor's degree in mechanical or biomedical engineering

Job description

Title: Principal Clinical Engineer

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

Why Imperative Care?

At Imperative Care, we are developing novel robotic-assisted technologies and interventional capabilities that will forever change the disparate outcomes of ischemic stroke – a disease that impacts close to a million people a year in the U.S., and 10 million worldwide. Not only is Imperative Care changing the way stroke is treated, but also bringing this treatment to the greater population who is currently without. We are actively building a team who is focused on developing novel solutions for this complex disease – a disease in which one in four adults will face in their lifetime.

What You’ll Do

As an expert level professional, the Principal Clinical Engineer will offer subject matter expertise to drive the development and improvement of Telos’ technology to elevate our products clinical application through intuitive design and meaningful improvements for physicians when using our products. This position will establish processes and best practices based on user needs that are transformed into relevant design requirements and are validated through preclinical studies. An incumbent in this role may supervise the work of junior staff, or other project professionals, internally or externally, where a Principal Clinical Engineer is the lead.

• Serve as the subject matter expert when establishing and implementing project plans for product development including preclinical testing, bench testing, model development needs, in-vitro test methods and plans and in-vivo animal studies.
• Oversee budget spending for pre-clinical projects and to ensure appropriate resources are used for the continuous development and improvement of internal testing capabilities.
• Contribute to strategies for the clinical use of products and recommend solutions that align with Company objectives.
• Collaborate with internal and external multi-disciplinary teams, with a broad scope of discretion, to identify critical issues and communicate project advancements.
• Provide regular updates to management regarding project status, and critical issues that may affect attainment of project completion dates. Collect input and direction to revise tactical plans for projects to move forward.
• Create and execute design verification and testing plans, leading team meetings where progress is discussed, decisions are made, and updates are communicated.
• Ensure project teams are conducting 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.
• Participate in the hiring, training and performance management of assigned team aiming toward productively achieving department goals.
• Stay current on information related to high quality pre-clinical testing capabilities.

What You’ll Bring

• Bachelor's degree in mechanical or biomedical engineer, or related discipline and a minimum of 12 years of related experience in the medical device or related regulated industry or equivalent combination of education and work experience
• Preferred extensive experience in a clinical/technical innovation role, with specific focus on process, GLP, HFU, and/or assessing design and usability of endovascular or neurovascular devices.
• Preferred prior experience leading technical teams through the execution of novel technologies.
• Ability to understand the intricate nuances to what is clinically meaningful to physicians who use similar type of technology.
• Ability to collaborate effectively with internal and external stakeholders at all levels to accomplish project goals, example: senior management, field experts, investors, regulatory agencies, etc.
• Deep knowledge and expertise in execution throughout the product development cycle.
• Expert knowledge of product design under ISO 13485 with ability to interpret regulations, guidelines and policy statements (QSR, MDD, and ISO), or any comparable quality systems.
• Experience and involvement with MDRs, IDEs, PMAs and 510(k) filings.
• Excellent written and oral communication skills with technical writing capabilities.
• Ability to prioritize multiple projects independently, and influence others with proven decision making, hands‑on and results‑oriented work style.
• Ability to travel 15‑20% of time.

Employee Benefits

include a stake in our collective success with stock options, bonus, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.

Salary Range: $188,000 – 220,000 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.