Senior Biosafety Engineer

Company Description It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do  a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.

Job Description Primary Function of Position:

Intuitive Surgical designs and manufactures pioneering medical devices for use in surgery. These devices consist of surgical instruments, endoscopes, diagnostic tools, and accessories used on a robotic surgical platform. Each patient-contact device is evaluated for biological safety according to relevant international standards.  The Biological Safety Group at Intuitive are responsible for the definition, implementation, and communication of our biological safety program under the guidance of board-certified toxicologists.

The Biosafety Development Engineer is responsible for managing and collaborating with teams in support of the biological safety evaluation process for new products and changes to existing products. The successful candidate must excel in a high-energy, small-focused team environment, be a quick learner, and have a commitment to high product quality. The candidate must have a strong understanding of toxicology and analytical chemistry requirements for evaluating the biological safety of medical devices.

The candidate should possess experience in designing and implementing biocompatibility safety evaluations, risk assessments, root-cause analysis, laboratory techniques, in vitro and in vivo test methods, and chemical analyses. The candidate should have experience in planning, tracking, creating process and procedure and implementing activities for the biological safety evaluation of medical devices, adhering to ISO 10993 guidelines. The candidate should have understating and knowledge of global regulatory requirements, compliance, quality management systems, audits, standards, and test methods for the biological safety evaluation and risk assessment of medical devices.

A strong sense of shared responsibility and shared reward is required and the ability to make work fun and interesting.  Supporting you will be a technical services management team that knows and cares about what you are doing and wants you to succeed.

Roles and Responsibilities:

Work closely with toxicologists and other specialists to support and implement the biological safety program at Intuitive; collaborate with biosafety group members to develop safety assessment plans.

Serve as the biological safety representative for new product development teams; attend meetings; communicate schedules; present at design reviews; and be responsible for peer interactions with engineering. With excellent organizational skills, prioritization abilities, and effective communication with project stakeholders, play a crucial role in managing multiple projects concurrently, ensuring the fulfillment of all compliance requirements.

Responsible for closely monitoring and ensuring that all processes and procedures are in line with…