Senior Biosafety Engineer

Intuitive; Sunnyvale (CA); Vor Ort; USD 140.000 - 210.000; Vollzeit

Zusammenfassung

Intuitive Surgical, a leader in robotic surgery, seeks a Biosafety Development Engineer to manage and collaborate on the biological safety evaluation process for new products and changes. The role requires deep toxicology and analytical chemistry knowledge, plus experience in biocompatibility safety evaluations, risk assessments, and regulatory compliance.

You will work with toxicologists and engineers to implement safety plans, track compliance, and coordinate with CROs to support FDA filings

Qualifikationen

• Experience designing and implementing biocompatibility safety evaluations and risk assessments.
• Familiarity with in vitro/in vivo test methods and chemical analyses.
• Ability to plan, track, and implement biosafety evaluations for medical devices per ISO 10993.

Aufgaben

• Collaborate with toxicologists and specialists to support the biological safety program.
• Represent biological safety on new product development and design reviews; communicate schedules.
• Ensure processes align with biocompatibility requirements set by regulatory bodies; implement changes as needed.
• Coordinate testing activities with CROs; request quotes and track schedules.
• Create and maintain project management tools to track biosafety activities and progress.
• Maintain comprehensive tracking for all compliance projects and ensure accessible documentation.
• Engage with stakeholders to address requirements and inquiries; communicate clearly.
• Support regulatory filing activities including FDA 510(k) submissions and MDR compliance.

Kenntnisse

Toxicology

Analytical chemistry

Biocompatibility

Regulatory understanding

Project coordination

Tools

ISO 10993 standards

CRO coordination

Document management systems (Agile)

Jobbeschreibung

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 the biocompatibility requirements set by relevant regulatory bodies. This includes conducting assessments, reviewing documentation, and implementing necessary changes to achieve compliance.

• Support sustaining and supplier engineering programs by collecting information on design changes for patient-contact materials and coordinating the execution of biological safety assessment plans.

• Responsible for continuously reviewing and updating biological safety processes and procedures based on current standards. This includes staying informed about the latest regulatory requirements and industry best practices to ensure our standards remain accurate and up to date.

• Create and maintain project management tools to track biological safety activities and communicate progress on commitments to project leaders and business unit executives.

• Responsible for establishing and maintaining a comprehensive tracking system for all compliance-related projects. This includes documenting project progress, milestones, and any necessary updates or changes. Ensure that all project documentation is easily accessible to the relevant stakeholders.

• Engage directly with project stakeholders to address any requirements, processes, or compliance-related inquiries. able to effectively communicate complex information in a clear and concise manner will be crucial to ensuring a smooth compliance process.

• Support biosafety plans, coordinate chemical characterization and biocompatibility testing activities at CRO laboratories; understand testing needs; request quotes; coordinate test articles; and track schedules.

• Support the creation and archiving of documentation that supports the biological safety of intuitive products; write reports and release them in the document management system (Agile)

• Maintain an ISI biological safety material database and provide computer-generated reports as needed.

• Assist engineering teams in choosing patient-contact materials based on prior usage, and assist in describing design, material, process, and supplier modifications for biosafety evaluation.

• The role involves supporting regulatory filing activities, including FDA 510(k) submissions (and other filing strategies), OUS country registration activities, MDR compliance certification, and other regulatory support needs.

• Develop a working understanding of medical device biocompatibility, including relevant national and international standards, methods for biosafety end-point testing, and other regulatory requirements.