Principal Clinical Engineer

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

Benefits offered by this job

Stock options

Bonus

401k plan

Health benefits

Generous PTO

Parental leave program

Job summary

Imperative Care in Campbell, California is seeking a Principal Clinical Engineer to drive clinical application improvements for Telos technology. The role demands expert level experience, leadership of project teams, and oversight of preclinical testing within design controls and regulatory standards.

You will collaborate with cross-functional groups, guide test planning, and contribute to strategies for clinical product use while ensuring QA and regulatory compliance.

Qualifications

• Bachelor's degree in mechanical or biomedical engineering with at least 12 years in medical devices or a regulated industry.
• Preferred experience in clinical/technical innovation focusing on process, GLP, HFU, and usability of endovascular or neurovascular devices.
• Preferred prior experience leading technical teams through novel technology execution.
• Ability to translate clinical needs into design requirements for physicians.
• Ability to collaborate with internal/external stakeholders at all levels to achieve goals.
• Deep knowledge across the product development lifecycle.
• Expertise in ISO 13485 design, interpreting QSR, MDD, ISO regulations, or similar quality systems.
• Experience with MDRs, IDEs, PMAs and 510(k) filings.
• Strong written and oral communication with technical writing capabilities.
• Ability to prioritize multiple projects and demonstrate decisive, hands-on work.
• Willingness to travel 15-20%.

Responsibilities

• Serve as SME when establishing project plans for product development including preclinical and bench testing, model development, and in vitro/in vivo studies.
• Oversee budget spending for pre-clinical projects and ensure resources support ongoing development.
• Contribute to clinical-use strategies and align solutions with company objectives.
• Collaborate with multidisciplinary teams to identify issues and communicate progress.
• Provide regular updates to management and revise tactical plans as needed.
• Create and execute design verification and testing plans and lead progress meetings.
• Ensure compliance with design controls and global regulatory requirements.
• Participate in hiring, training and performance management of the team.
• Stay current on high-quality pre-clinical testing capabilities.

Skills

Leadership

Clinical/technical innovation

Regulatory knowledge

Communication skills

Project management

Travel readiness

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.

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.