Therapy CDE Lead - Tissue

Intuitive•Sunnyvale, CA

About The Position

In this very senior role, the individual will work on solving complex, multidisciplinary problems that have significant impact across multiple programs. The position requires deep clinical expertise, strong technical acumen, and experience in preclinical evaluation and physician engagement to develop robust evaluation strategies having to do with tissue. This role serves as a key cross-functional stakeholder, partnering closely with Design Engineering to inform product decisions. In collaboration with Medical Office and Product Management, the individual identifies unmet clinical needs and drives the definition, development, and validation of innovative product solutions. The individual will explore and evaluate new endoluminal therapeutic applications in preclinical settings around tissue. As a tissue subject matter expert, they will lead cross-functional teams and mentor others through complex problem-solving efforts.

Requirements

4 year degree & Master’s degree in Engineering, Biology, or related field.
15+ years in the medical device industry.
10+ years in clinical development and preclinical evaluation.
Demonstrated experience with pre-clinical model development and validation of Class III products
Must be an expert on tissue and show it throughout your resume.
Strong understanding of complex engineering systems.
Experience collaborating with physicians.

Nice To Haves

PhD is a plus
Experience working cross-functionally across product development teams.
Experience driving products from concept through commercialization.
Experience in validation strategy and testing.
Self-motivated and able to work independently.
Effective communicator.
Willingness to travel up to 15%.

Responsibilities

Apply in-depth knowledge of tissue therapeutic clinical procedures and medical technologies for needs discovery and evaluation strategies.
Collaborate with medical officers, physicians, and clinical users to understand clinical needs.
Partner with cross-functional teams (Design Engineering, Product Management, Quality, Regulatory) to define product requirements.
Develop evaluation strategies including product characterization and tissue-effect assessments.
Assess clinical risks and define mitigation strategies.
Drive decision-making and escalate critical issues appropriately.
Lead planning and execution of evaluation and product launch strategies.
Mentor and guide junior team members.