Senior Clinical Specialist, Clinical Engineering

This is a fully remote position, open to applicants in California.

📋 Description

• Offer clinical assistance for innovative, dependable, and safe products that fulfill clinical requirements and adhere to regulatory standards.

• Ensure that products satisfy market functional criteria for user-friendliness, ease of learning, and competitive positioning.

• Confirm that products comply with international human factors standards, including IEC 62366.

• Implement company devices in clinical settings, covering setup, testing, analysis, and validation.

• Provide both on-site and remote assistance during pre-clinical and clinical procedures.

• Work closely with healthcare professionals to resolve technical challenges and enhance device performance.

• Utilize manuals, guides, and presentations to train healthcare providers effectively.

• Conduct training sessions for physicians, nurses, and technicians on the operation and maintenance of products.

• Incorporate clinical insights, user requirements, and market feedback into product development processes.

• Engage in root cause analysis regarding clinical performance challenges.

• Recognize emerging trends, technologies, and best practices within clinical engineering and medical device development.

• Assist regulatory affairs and submissions by ensuring that clinical and engineering documentation is thorough and precise.

• Build and maintain relationships with physicians and healthcare professionals.

• Mentor other Clinical Specialists as needed.

⛳️ Requirements

• Bachelor’s degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related field, or equivalent experience.

• Over 6 years of progressive experience in clinical engineering, medical device development, or a related field.

• Familiarity with Cardiac Ablation Procedures is essential.

• Experience with Class II or Class III devices is highly preferred.

• Solid understanding of global regulatory processes, clinical testing requirements, and post-market surveillance.

• Extensive knowledge of medical device design, engineering principles, regulatory standards (e.g., FDA, ISO 13485), and quality benchmarks.

• Strong analytical and problem-solving abilities.

• Exceptional verbal and written communication skills.

• Proficient in managing time, resources, and multitasking effectively.

• Capable of both hands-on implementation and strategic thinking.

• Ability to collaborate as a team member, multitask, and adapt to evolving priorities and requirements.

• High level of computer proficiency required, including MS Word, Excel, and PowerPoint.

• Willingness to travel up to 60% of the time; overnight domestic and/or international travel may be necessary.

• Capability to lift 10-15 pounds.

🏝️ Benefits

• A range of health insurance plans and supplemental insurance options.

• 401k retirement savings plan.

• Stock options awards.

• Employee Stock Purchase Plan (ESPP).

• Paid time off.

• Paid holidays.

• Flexible work schedule.

• Wellness program, which includes an onsite gym and mindfulness classes.

• Opportunities for professional and personal growth and development.