Senior Clinical Development Engineer

Job Description

Primary Function of Position

The Senior Clinical Research Engineer in our Future Forward organization will lead the design and development of new product concepts prior to commercial launch by leveraging in-depth clinical, scientific, and technical expertise. This individual will collaborate closely with engineers, physicians, interaction designers, human factors, training and technical publication specialists, and various internal and external stakeholders to guide product and procedure development. They will also play a key role in proctoring early-stage feasibility clinical studies, gathering case insights to support technology advancement, identifying and documenting user needs, managing product requirements, assessing clinical risks, and providing design guidance for clinical and commercial design and development.

Essential Job Duties

Pre-clinical research and commercial concept development:

• Research disease states and medical technologies associated with new business opportunities to become an expert on new products and their clinical applications.
• ​Collaborate with marketing partners and clinicians to identify and understand marketing needs.
• Work with key opinion leaders, subject matter experts, and other stakeholders to identify clinical goals and translate those needs into user-centric designs for new platforms, procedures, instruments, and accessories.
• Collaborate closely with engineers and physicians to define and evaluate clinical performance goals, potential safety and usability risks for new products in early-phase development.
• Develop and execute clinical derisking pathways, including pre-clinical and clinical feasibility studies, to ensure technology advancement and readiness for commercial launch.
• Conduct design iteration assessments of products both internally and with external key opinion leaders.
• Develop and execute a preclinical evaluation strategy in advance of human trials and for regulatory submissions.
• Provide subject matter expertise to user manual and training documentation development.
• Support regulatory documentation and submissions.
• Demonstrate an analytical approach to identify potential product enhancements and new product ideas.

Clinical research and innovation:

• Lead and execute early-stage feasibility clinical studies, pilot and pivotal clinical trials to support technology development for regulatory and reimbursement strategies.
• Identify and drive product enhancements and new product ideas by applying an analytical approach to understanding the clinical needs of physicians and users.
• Collect and analyze clinical study insights to inform new product requirements, training needs, manage clinical risks adhering to quality management systems.
• Design, develop, and execute clinical evaluations of prototypes with the ability to translate feedback to the engineering team for technology acceleration.
• Develop intellectual property for novel clinical applications and technologies.

Others:

• Keep the organization’s vision and values at the forefront of decision making and action.
• Perform other duties as required to support the company's overall strategy and goals.

Qualifications

Required Skills and Experience

• Fluent in medical procedure terminology and sound knowledge of anatomy.
• Ability to understand complex robotic systems and software algorithms.
• Experience working in an operating room or interventional suite environment.
• Experience collaborating with physicians and collecting feedback on clinical use of the product.
• Excellent mechanical and technical aptitude, and intuition for spatial relations, including the ability to understand complex mechanical products.
• Excellent analytical capability and practical skills to develop and test a clinical hypothesis and draw succinct conclusions.
• Excellent teamwork skills with proven ability to cultivate collaboration across multiple disciplines to ensure timely project success.
• Proven success recognizing critical issues and driving them to closure by taking coordinated action.
• Product development and Design Controls experience.
• Effective communication skills (verbal, written, presentation).
• Self-starter needing minimal supervision.
• Self-confident and able to react quickly under pressure.

Required Education and Training

• Minimum of a B.S. in Biomedical Engineering, Mechanical Engineering, or similar.
• 8+ years of related experience in clinical engineering and/or product development within the medical device industry.

Working Conditions

• Must be available to work full-time and commute/relocate to Sunnyvale, CA.
• Up to 30% travel. Some international travel will be required.
• Primary Location: Sunnyvale, CA.

Preferred Skills and Experience  

• Experience with on-site clinical trial support.
• Experience with commercial product launch.
• Familiar with intellectual property development and patent assessment.