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Senior Clinical Specialist, Clinical Engineering
Pulse Biosciences, Inc.. Provide clinical support for innovative, reliable, and safe products meeting clinical needs and regulatory standards .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical engineering and medical device development, with a strong focus on regulatory compliance, user training, and product optimization. Capable of integrating clinical insights and market feedback to enhance product functionality and safety.
Highest-signal resume keywords
Clinical Engineering ExperienceRegulatory Compliance KnowledgeCardiac Ablation Procedures ExperienceMedical Device Design ExpertiseTraining and Mentoring Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Biomedical EngineeringElectrical EngineeringMechanical EngineeringClinical Testing RequirementsQuality StandardsRegulatory RequirementsAnalytical SkillsProblem-Solving SkillsDocumentation SkillsDevice Validation
Soft Skills
Excellent Communication SkillsTime ManagementTeam CollaborationAdaptabilityStrategic Thinking
Tools & Technologies
MS WordMS ExcelMS PowerPoint
Industry Keywords
Class II DevicesClass III DevicesIEC 62366FDAISO 13485Post-Market SurveillanceHuman-Factors StandardsClinical SupportHealthcare Provider CollaborationRoot Cause Analysis
About the role
Key responsibilities & impact- Provide clinical support for innovative, reliable, and safe products meeting clinical needs and regulatory standards
- Ensure products meet market functional requirements for ease-of-use, ease-of-learning, and market competitiveness
- Ensure products meet international human-factors standards such as IEC 62366
- Deploy company devices into clinical environments, including setup, testing, analysis, and validation
- Provide on-site and remote support during pre-clinical and clinical procedures
- Collaborate with healthcare providers to address technical issues and optimize device performance
- Use manuals, guides, and presentations to educate healthcare providers
- Conduct training for physicians, nurses, and technicians on product use, operation, and maintenance
- Integrate clinical insights, user needs, and market feedback into product development
- Participate in root cause analysis for clinical-performance issues
- Identify emerging trends, technologies, and best practices in clinical engineering and medical-device development
- Support regulatory affairs and regulatory submissions by ensuring clinical and engineering documentation is complete and accurate
- Develop and sustain relationships with physicians and healthcare professionals
- Mentor other Clinical Specialists as needed
Requirements
What you’ll need- Bachelor’s degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or related field or similar experience
- 6+ years of progressive experience in clinical engineering, medical device development, or related field
- Experience with Cardiac Ablation Procedures
- Experience with Class II or Class III devices is highly desirable
- Strong understanding of global regulatory processes, clinical testing requirements, and post-market surveillance
- Deep knowledge of medical device design, engineering principles, regulatory requirements (e.g., FDA, ISO 13485), and quality standards
- Strong analytical and problem-solving skills
- Excellent verbal and written communication skills
- Ability to effectively manage time, manage resources and multi-task
- Ability and willingness to both "roll up sleeves" and think strategically
- Ability to work as a team member, multi-task and adapt to changing priorities and requirements
- High level computer skills required, including MS Word, Excel, and PowerPoint
- Ability to travel up to 60% of the time; overnight domestic and/or international travel may be required
- Ability to lift 10-15 pounds
Benefits
Comp & perks- A variety 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, including onsite gym and mindfulness classes
- Professional and personal growth and development opportunities