Senior Clinical Engineer

Summary

Join Noah Medical, a leading medical robotics company, as a Senior Clinical Engineer (Post-Market). In this role, you will collaborate with cross-functional teams to ensure clinical value, safety, and best practices for our next-generation robotic platform. You will investigate complaints, analyze data to identify trends, and provide feedback to improve product design and training. This position requires strong technical expertise, experience in the medical device industry, and excellent communication skills. You will also mentor a team and proactively identify emerging clinical technologies. The position offers a competitive salary and benefits package, including health insurance, 401K, stock purchase plans, tuition reimbursement, paid time off, and flexible work arrangements.

Requirements

• 5 to 10 years of experience in a medical devices industry
• Bachelor’s degree in Engineering or Science; Master’s degree preferred
• Strong technical experience and aptitude
• Strong understanding of ISO 14971, 21 CFR Part 820
• Ability to effectively communicate concepts, ideas, and knowledge to other individuals and teams
• Knowledge of basic anatomy, clinical terminology, and general surgical techniques
• Knowledge of fundamentals of robotics or electromechanical systems
• Experience in the regulated medical device environment, including but not limited to document control processes, design control processes, protocol development, and report writing
• Experience working with healthcare providers in a hospital environment
• Ability to travel domestically up to 25% of the time

Responsibilities

• Develop internal expertise in clinical domains relevant to the company’s products
• Understand current state of end-user and patient environment
• Build knowledge about relevant anatomy and disease states
• Become aware of alternative and competing treatment modalities
• Remain current with the latest in scientific publications relevant to the company’s products
• Attend key scientific conferences and engage with clinicians
• Conduct Post-Market Surveillance investigations related to Use Errors and Adverse Events
• Investigate serious injury / adverse event and death complaints daily
• Investigate potential use error complaints daily
• Provide input to clinical conclusion to be included in the complaint reports
• Escalate complaints that require additional review to other complaints investigation teams
• Accurately select Risk (Hazard, Harms, Severity) for investigated complaints
• Collaborate with cross-functional teams including clinical engineering, human factors, and engineering to provide relevant clinical information related to investigated complaints to influence improvements to the design
• Analyze complaint data to identify trends, issues, or systemic discrepancies
• Provide feedback to engineering on potential design improvements
• Monitor and escalate trends of complaints and system issues in the field
• Provide the risk management input data based on real-use data from the field, required to update existing or include new failure modes into risk management files
• Collaborate with Medical Education and Sales Training teams to provide relevant clinical and use information related to complaints investigation to update training material and processes
• Analyze complaint data to Monitor and escalate trends of complaints and system issues in the field
• Identify trends, issues, or systemic discrepancies
• Provide feedback to Medical Education and Sales Training on training material and process improvements to improve the system usage
• Lead the development of enhanced usage techniques and potential improvements within the existing product in the field
• Support the Service and Commercial team during new customer installations and system launches
• Own the creation supporting documentation during product development for the quality system and regulatory submissions
• Plan project timeless and help clear resource dependencies allocation optimization for crossfunctional projects
• Architect and oversee the pre-clinical evaluation strategy for multiple product development efforts, ensuring alignment with business objectives
• Mentor and develop a high-performing team of clinical engineers, fostering a culture of innovation and excellence
• Proactively identify emerging clinical technologies and assess their potential impact on the company's product strategy
• Perform other duties as directed

Preferred Qualifications

Master’s degree

Benefits

• Competitive pay
• Health insurance
• 401K and stock purchase plans
• Tuition reimbursement
• Paid time off plus holidays
• Flexible approach to work with remote, hybrid, field or office work schedules