Biosafety Development Engineer

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

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, 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. 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 toxicologist and other specialists in supporting and implementing the biological safety program at Intuitive; collaborate with biosafety group members in developing safety assessment plans

• Serve as the biological safety member to new product development teams; attend meetings, communicate schedules, present at design reviews and be responsible for peer interactions with engineering

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

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

• Coordinate chemical characterization and biocompatibility testing activities at CRO laboratories in support of biosafety plans; understand testing needs, request quotes, coordinate test articles and track schedules

• Support the creation and archival of documentation that supports the biological safety of Intuitive products; write reports, release in document management system (Agile)

• Maintain ISI biological safety material database; provide computer generated reports as needed

• Support engineering teams in the selection of patient-contact materials based on previous use and support the description of design, material, process and supplier changes to be evaluated for impact to biosafety

• Support 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

Qualifications

Skill/Job Requirements

• Minimum Bachelor's degree in medical life science or engineering

• Minimum 5 years experience in medical device product safety, product development or related areas

• Training in medical device biocompatibility testing and management or equivalent preferred

• Proven project management skills; PMP certification a plus

• Good organizational and people skills; work effectively in team environment

• In Vitro and In Vivo laboratory testing experience preferred, but can be learned through training

• Knowledge of MS Office applications

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 Employment 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.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

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.

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 Employment 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.

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.