Senior Toxicologist

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

The Senior Toxicologist plays a key role in ensuring the biocompatibility and safety of medical devices, materials, and processes in compliance with global regulatory standards (ISO 10993, FDA, EU MDR). This position is responsible for conducting toxicological risk assessments, developing safety strategies, and supporting regulatory submissions. The applicant will work collaboratively with cross-functional teams, including engineering, quality, regulatory, and clinical teams, to evaluate and mitigate potential toxicological risks associated with medical device materials and components. Specific emphasis will be placed on candidates with proven experience supporting Class III medical devices.

Essential Job Duties

• Conduct and oversee toxicological risk assessments for medical devices and materials to ensure compliance with ISO 10993 standards and global regulatory requirements.
• Manage biocompatibility and chemical characterization studies, collaborating with contract research organizations (CROs) to design, plan, and interpret toxicological testing.
• Evaluate potential toxicological hazards of new materials, manufacturing processes, and device modifications.
• Provide guidance on material selection, ensuring the use of safe and biocompatible materials in product development.
• Support regulatory submissions by preparing toxicological safety assessments and responding to regulatory inquiries.
• Stay abreast of emerging toxicological methodologies, computational toxicology models, and regulatory updates to improve risk assessment approaches.
• Act as a subject matter expert and mentor within the organization, educating internal teams on toxicological and biocompatibility considerations.
• Collaborate with engineering, supplier quality, and manufacturing teams to ensure toxicological compliance from design to commercialization for class III medical devices.
• Participate in scientific conferences, regulatory meetings, and industry working groups to contribute to the advancement of toxicology practices in the medical device industry.

Qualifications

Required Skills and Experience

• Extensive experience in toxicological risk assessment and medical device safety evaluations.
• Proven knowledge of biocompatibility testing methodologies and regulatory frameworks (ISO 10993, FDA, EU MDR, etc.).
• Demonstrated expertise in designing, conducting, and interpreting toxicology and biocompatibility studies.
• Proven ability to work cross-functionally and effectively communicate toxicological findings to technical and non-technical audiences.
• Experience working with regulatory bodies and preparing toxicology-related regulatory documentation for Class III devices.
• Proven analytical and problem-solving skills with attention to detail and scientific rigor. • Excellent written and verbal communication skills.

Required Education and Training

• Master's degree in Toxicology, Biomedical Science, or a related field with 5+ years of experience in toxicological risk assessment and biocompatibility evaluation, preferably in the medical device industry.

OR

• Ph.D. in Toxicology, Biomedical Science, or a related field with 2+ years of experience in the same areas.
• Board certification (e.g., DABT) is highly preferred.

Working Conditions

• Onsite role based in Sunnyvale, CA.
• May involve occasional travel (up to 2%) for regulatory meetings, conferences, or external collaborations.

Preferred Skills and Experience

• Experience with computational toxicology and in silico modeling.
• Expertise in extractables and leachables (E&L) assessments for Class III devices.
• Familiarity with Good Laboratory Practices (GLP) and regulatory compliance strategies.
• Knowledge of advanced analytical techniques (e.g., mass spectrometry, chromatography) for chemical characterization.
• Experience with engaging directly with regulatory authorities for toxicological discussions.
• Exceptional project management skills with the ability to drive multiple initiatives simultaneously.

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

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.

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 salary ranges are listed.