Principal Clinical Engineer

Title: Principal Clinical Engineer

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

Why Telos Health?

At Telos Health, an Imperative Care company, 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 Telos 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

We are looking for a talented principal clinical engineer and expert professional leader to help shape Telos’ technology through intuitive design and meaningful clinical application. You will be responsible for translating user needs into relevant design requirements and validating through preclinical studies.

A Principal Clinical Engineer has real world clinical experience in the neurovascular field and understands the intricate nuances to what is clinically meaningful to physicians when using our products. The ideal candidate also has a strong communication and leadership skills as well as a proven ability to work cross-functionally between physician advisors, R&D, marketing, and clinical affairs.

• Build relationships and Interface directly with clinician customers and advisors
• Understand and drive education around how product(s) will be used clinically and how they affect the Company’s businesses.
• Thoroughly understand the current clinical procedures and associated products in order to provide specific and direct insight into product development recommendations.
• Thoroughly understand the current anatomy to the level of educating current employees and new hires in order to provide effective insights to drive engineering developments
• Interface with project teams, marketing, and senior management to manage technology demonstrations and evaluations for physicians, employees, investors, etc. as requested
• Proactively seek out new information to establish, train, and maintain high quality pre-clinical testing capabilities including but not limited to: Good Manufacturing Practices, applicable FDA and Regulatory requirements.
• Establish and execute detailed plans to support internal development projects with preclinical testing including bench testing, model development needs, in-vitro test methods and plans and pre-clinical studies
• Mentor team, organize and lead team meetings.
• Develop and maintain budget for pre-clinical department to support projects and to continually develop and improve internal testing capabilities
• Support project teams to ensure pre-clinical testing of new products are conducted within the design control and quality system
• Support creation and execution of design verification and testing plans
• Plan and lead team regular meetings to facilitate communication and decision making
• Ensure products are designed, developed, tested, manufactured and documented in accordance with regulatory requirements for approval of products by US and foreign regulatory agencies.
• Provide regular feedback to management regarding project status, as well as other critical issues which affect the attainment of project completion dates.
  
  

What You’ll Bring

• Bachelor's degree in Mechanical or Biomedical Engineering or related discipline with 12 years of related experience; or 8 years with MS or Advanced degree; or equivalent combination of education and work experience in the medical device or related regulated industry.
• Experience should include 5 years in pre-clinical/technical innovation role, with specific focus on the process, GLP, HFU, and/or assessing design and usability of endovascular devices, preferably for neurovascular use.
• Proven ability to work constructively with people at all levels of company, including senior management
• Proven ability to collaborate effectively with others to accomplish project goals
• Multiple experiences in product development and execution through significant portions of the product development cycle
• Experience with developing products under design control per ISO 13485 quality or comparable quality system
• Prior experience in leading/mentoring an experienced clinical engineering or technical team in the execution of something novel
• Experience and involvement with MDRs, IDEs, PMAs and 510(k) filings
• Solid knowledge and interpretation of applicable regulations, guidelines and policy statements (QSR, MDD, and ISO)
• Excellent written and oral communication skills; technical writing capabilities are a must
• A proven decision maker, hands-on and action-oriented style must be evident
• Proven ability to manage a team of professionals and prioritize multiple projects independently
  
  

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! Apply today.

Salary Range: $165,000 to 180,000 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.