Senior Medical Device 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

Job Description:

The Future Forward group within Intuitive Surgical is searching for a Senior Medical Device Development Engineer to support design controls and testing and manage reprocessing activities for instruments and accessories of a new robotic surgical platform.  This work will include development of risks and requirements documents, testing protocols, and verification and validation for reprocessed instruments, as well as other parts of the system as necessary.  As an early member of the team, this role is an exciting opportunity to help define the eventual product from early prototypes through clinical trials and into product launch.  This engineer will be expected to supervise the work of contractors and junior engineers as necessary.

As part of the team, the engineer will work with team members and subject matter experts to:

• Manage risks and requirements
• Support development of test methods and protocols
• Supervise/coordinate test execution
• Execute dry run and formal validations
• Develop reprocessing workflows for all relevant devices
• Draft reprocessing IFU
• Manage reprocessing workflows for life test, biocompatibility
• Support 3rd party collaborations, including purchasing equipment and accessories as necessary
• Support reprocessing at FHU site

Qualifications

Desired Skills and Experience:

• Minimum BS in relevant engineering discipline
• Minimum 6 years experience, at least 4 years in medical device industry
• Experience with design controls management in a medical device environment
• Experience drafting, releasing, executing, and closing test protocols for verification and validation(V&V) of a medical device (experience with Polarion requirements management software preferred)
• Prior experience qualifying medical devices for cleaning, disinfection, and/or sterilization processes
• Experience with sterilization and reprocessing processes in hospitals
• Experience supervising the work of contractors or junior team members
• Strong organizational skills and proven ability to work on multiple fast-paced project threads simultaneously
• Clear and efficient documentation skills

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.

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.

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