Therapy CDE Lead - Tissue

Job Description

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 involving 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, leading cross‑functional teams and mentoring others through complex problem‑solving efforts.

• 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.

• 4‑year degree & Master’s degree in Engineering, Biology, or related field. PhD is a plus.
• 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.

• 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%.

• Base Compensation Range Region 1: $186,100 USD – $267,900 USD
• Base Compensation Range Region 2: $158,200 USD – $227,700 USD
• Shift: Day
• Workplace Type:
  Set Schedule – Onsite weekly (percentage of onsite work defined by the leader)

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.