Senior Biosafety Engineer

Intuitive•Sunnyvale, CA

2d•$138,400 - $234,200•Onsite

About The Position

Intuitive Surgical designs and manufactures medical devices for robotic-assisted surgery. Patient-contact devices are evaluated for biological safety against 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 Biosafety Development Engineer manages and collaborates with teams on biological safety evaluations for new products and changes to existing products. The role applies knowledge of toxicology, analytical chemistry, biocompatibility, risk assessment, laboratory methods, chemical analyses, and global regulatory requirements to support high-quality medical device development. It works with toxicologists, specialists, engineering teams, suppliers, contract research organization (CRO) laboratories, and other stakeholders to plan, coordinate, document, and track biological safety activities in accordance with relevant requirements, including ISO 10993. The position supports regulatory filing activities, including FDA 510(k) submissions, international country registrations, MDR compliance certification, and other regulatory needs. It also maintains biological safety processes, procedures, project-tracking tools, and material databases, and prepares and archives supporting documentation. The role is listed as a day-shift position and is onsite weekly, with the percentage of onsite work defined by the leader.

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 biological safety evaluations for medical devices in accordance with ISO 10993 guidelines.
Knowledge and understanding of global regulatory requirements, compliance, quality management systems, audits, standards, and test methods for biological safety evaluation and medical-device risk assessment.
Strong organizational, prioritization, communication, and interpersonal skills; ability to work effectively in a team and manage multiple projects.
Knowledge of MS Office applications.
A strong sense of shared responsibility and shared reward, and the ability to make work engaging.

Nice To Haves

Training in medical-device biocompatibility testing and management, or an equivalent program.
PMP certification; it is a plus.
In vitro and in vivo laboratory testing experience; this may also be acquired through training.

Responsibilities

Work with toxicologists and other specialists to support and implement Intuitive’s biological safety program and develop safety assessment plans.
Represent biological safety on new product development teams; attend meetings, communicate schedules, present at design reviews, and coordinate with engineering stakeholders.
Manage multiple projects and ensure applicable compliance requirements are fulfilled.
Monitor processes and procedures for alignment with biocompatibility requirements; conduct assessments, review documentation, and implement changes as needed.
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 to reflect current standards, regulatory requirements, and industry practices.
Create and maintain project-management tools to track biological safety activities and communicate progress and commitments to project leaders and business-unit executives.
Maintain tracking and documentation for compliance projects, including progress, milestones, updates, and stakeholder access to project records.
Address stakeholder inquiries about requirements, processes, and compliance, communicating complex information clearly.
Support biosafety plans and 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 company products; write reports and release them in the Agile document management system.
Maintain the biological safety material database and provide computer-generated reports as needed.
Assist engineering teams in selecting patient-contact materials based on prior usage and describing design, material, process, and supplier modifications for biosafety evaluation.
Support regulatory filing activities, including FDA 510(k) submissions and other filing strategies, international country registrations, MDR compliance certification, and other regulatory support needs.
Develop a working understanding of medical-device biocompatibility, relevant national and international standards, biosafety endpoint testing methods, and regulatory requirements.