Therapy CDE Lead - Tissue

Therapy CDE Lead - Tissue

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.

Roles and 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.

Skills and Qualifications

• 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.

Nice to have:

• 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%.

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

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.

Mandatory Notices

U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR 743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process).

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate's experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate's qualifications, consistent with applicable law.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.

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