Senior Biosafety Engineer

Intuitive•Sunnyvale, CA

About The Position

Intuitive Surgical designs and manufactures medical devices used in surgery, including surgical instruments, endoscopes, diagnostic tools, and accessories for robotic surgical platforms. Patient-contact devices are evaluated for biological safety under relevant international standards. The Biological Safety Group defines, implements, and communicates the company’s biological safety program under the guidance of board-certified toxicologists. The Senior Biosafety Engineer supports biological safety evaluations for new products and changes to existing products. The role collaborates with toxicologists, engineering teams, project stakeholders, suppliers, and contract research organization (CRO) laboratories to plan and coordinate assessments and testing in accordance with ISO 10993 and applicable regulatory requirements. The position also supports documentation, regulatory filings, material selection, process improvement, and project tracking. The successful candidate is expected to manage multiple projects, communicate effectively across teams, maintain a strong focus on product quality and compliance, and contribute in a collaborative team environment.

Requirements

Bachelor’s degree in medical life science or engineering; a master’s degree is preferred.
At least 8 years of experience in medical device product safety, product development, or related areas.
Strong understanding of toxicology and analytical chemistry requirements for evaluating medical-device biological safety.
Experience designing and implementing biocompatibility safety evaluations, risk assessments, root-cause analysis, laboratory techniques, in vitro and in vivo test methods, and chemical analyses.
Experience planning, tracking, creating processes and procedures, and implementing activities for medical-device biological safety evaluation in accordance with ISO 10993 guidelines.
Knowledge of global regulatory requirements, compliance, quality management systems, audits, standards, and test methods for biological safety evaluation and risk assessment of medical devices.
Strong organizational, prioritization, communication, and interpersonal skills, including the ability to manage concurrent projects and communicate complex information clearly.
Ability to work collaboratively in a team environment and demonstrate shared responsibility.
Knowledge of MS Office applications.

Nice To Haves

Training in medical-device biocompatibility testing and management, or an equivalent program.
Project management experience; PMP certification is a plus.
In vitro and in vivo laboratory testing experience; this may also be acquired through training.
A master’s degree in medical life science or engineering.

Responsibilities

Work with toxicologists and other specialists to support and implement Intuitive’s biological safety program, and collaborate with biosafety group members to develop safety assessment plans.
Represent biological safety on new product development teams; attend meetings, communicate schedules, present at design reviews, and interact with engineering teams.
Manage multiple projects and coordinate with stakeholders to meet compliance requirements and project commitments.
Monitor processes and procedures for alignment with regulatory biocompatibility requirements; conduct assessments, review documentation, and implement necessary changes.
Support sustaining and supplier engineering programs by collecting information about design changes to patient-contact materials and coordinating biological safety assessment plans.
Review and update biological safety processes and procedures in response to current standards, regulatory requirements, and industry practices.
Create and maintain project management tools and tracking systems for biological safety and compliance projects; document progress and milestones, communicate status, and keep project documentation accessible to stakeholders.
Respond to stakeholder questions about requirements, processes, and compliance.
Coordinate chemical characterization and biocompatibility testing at CRO laboratories, including understanding testing needs, requesting quotes, coordinating test articles, and tracking schedules.
Create and archive documentation supporting the biological safety of products; write reports and release them in the Agile document management system.
Maintain the ISI biological safety material database and provide computer-generated reports as needed.
Assist engineering teams with patient-contact material selection based on prior use, and document design, material, process, and supplier modifications for biosafety evaluation.
Support regulatory filing activities, including FDA 510(k) submissions and other filing strategies, OUS country registrations, MDR compliance certification, and other regulatory support needs.
Develop and maintain a working understanding of medical-device biocompatibility, relevant national and international standards, biosafety endpoint testing methods, and regulatory requirements.