Sr. Clinical Development Engineer

Job description

Primary Function of Position

This Sr. Clinical Development Engineer (CDE) position reports to the Clinical Development Engineering Manager on the Ion Endoluminal platform. In this position, Sr. CDE utilizes their in-depth clinical, technical and design control knowledge to collaborate with physicians and design engineering to discover, define, develop, and validate new product solutions for flexible robotic catheter platforms. Their primary focus is to understand user needs, establish clinical and engineering requirements, consider clinical risks and identify solutions to guide product development.

This position will also allow exploration of future robotic clinical applications and solutions.

Roles and Responsibilities

The responsibilities for this position include: Clinical and Technical knowledge

• Apply in-depth clinical knowledge and technical system understanding in defining and developing products based on clinical needs
• Collaborate with physicians and key clinical users on clinical procedure development and understanding product feedback Clearly define clinical need and requirements for product
• Develop test models and test methods for clinically relevant product evaluations.
• Assess potential clinical risks and propose mitigations as an input to product design
• Observe cases and communicate assessment of robotic value and/or opportunities
• Contribute expertise into clinical protocol design and strategy

Product Leadership

• Participate in early design investigation teams that are lean and efficient with a focus on product enhancements & new product ideas.
• Drive frequent stakeholder alignment and solicit appropriate user feedback
• Drive decision making and escalate key issues quickly
• Keep the organization’s vision and values at the forefront of decision making and action
• Educate cross functional team on clinical workflow
• Support product launches and/or clinical trials and collect early field feedback

Design Control

• Conduct clinical risk analysis for new products or updates
• Lead testing and clinical evaluations of new product features
• Collaborate with cross functional team members including regulatory, human factors, training, engineering and product management to determine design and development key inputs
• Drive design validation testing strategy for new products and get alignment on the strategy with key regulatory and engineering stakeholders

Qualifications

Skill/Job Requirements

Masters or PhD in Mechanical Engineering, Controls Engineering, Biomedical Engineering or similar Minimum of 4 years of clinical development and design control experience including the MS Experienced in driving medical device products and features from concept to market Experience collaborating with physicians and collecting feedback on clinical use of the products Experience understanding clinical harms and performing clinical risk analysis Fluent in medical terminology and sound knowledge of anatomy Nice to haves: Experience working in cross-functional teams and proven ability to cultivate collaboration across multiple disciplines (marketing, regulatory, quality, product design, engineering, human factors) to ensure project success.

Experience developing design validation strategy, protocol creation and testing Experience leading hands-on product evaluation testing in a pre-clinical lab setting Self-starter needing minimal supervision Self-confident and able to react quickly under pressure Ability to adapt priorities in a fast paced, dynamic, product development team Excellent verbal and written communications skills including presentation of technical content Travel: Ability to travel up to 25% of the time, internationally and domestic