Manager Clinical Research Engineering

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

The Team

The Advanced Research team at Intuitive is a cross-functional team dedicated to the creation of innovative medical technologies and robotic systems. We develop transformational technologies in order to address the major pain points and unmet needs in healthcare. Our goal is to revolutionize the future of healthcare by developing platforms and technologies that empower providers and teams to deliver life-enhancing care.

Primary Function of the Position The Clinical Research Engineering Manager will guide and mentor a talented Clinical Engineering team responsible for development of a robotic platform in early concept. The person will foster relationships across functions and along with the team communicate the customer need, safety risks, and feature value for a specialty where Intuitive does not currently have a commercial presence. The person will be a key stakeholder in selecting the winning concepts that balance performance, program risk, and commercial viability. The person will have a track record of effectively working closely with hardware and software engineering teams, Regulatory, Clinical Affairs, Quality, and more to collaboratively develop the novel system.

Essential Job Duties

The person will:

• Mentor an exceptional team of self-directed Clinical Engineers, encouraging an enthusiastic, exploratory, and innovative mindset in the team.
• Encourage the long-term professional development of the team by coaching and providing feedback in an ongoing basis.
• Establish sub-team priorities consistent with program goals. Facilitate priority alignment and track progress, adhering to budget and timelines.
• Identify, isolate, and plan to resolve high-risk questions that stand between today and confidence that we can meet the customer needs and program targets. In other words, reduce risks until they become implementation tasks.
• Bring a clinical voice to the design team by becoming an Intuitive resource on how procedures are currently done today, with an eye toward what they can become in the future.
• Work with key subject matter experts, physicians, and other stakeholders to identify clinical goals and translate those needs for user-centric design concepts.
• Be a key contributor in the design iteration process by developing and executing an experimental strategy to assess performance and safety of prototype designs.
• Research, develop, and design novel pre-clinical models.
• Develop novel procedures and workflows for novel robotic platform.
• Develop research plans and performance metrics for the pre-clinical assessment of a novel robotic platform to validate the safety and effectiveness of proposed designs. Provide data-driven feedback to the design team.
• Develop and execute a pre-clinical evaluation strategy in advance of human trials and for regulatory submissions.
• Drive on-site execution of early feasibility, pilot, and pivotal clinical trials including user training and case support.
• Keep the organization’s vision, values, strategy, and goals at the forefront of decision-making and action

Qualifications

Required Skills and Experience

• Track record of leading and developing sustainable teams
• Demonstrated ability to establish, track, and meet clear goals for the team
• Excellent organizational skills and demonstrated ability to manage fast-paced projects
• Ability to easily communicate with physicians and procedure staff using accurate medical terminology
• Experience observing medical procedures and partnering with physicians to identify areas of opportunity
• Demonstrated capacity for solving complex problems
• Demonstrated ability to work well with cross-functional partners
• Ability to effectively communicate in written and oral forms across all levels of stakeholders (functional peers, cross-functional partners, leadership, customers)
• Demonstrated ability to set priorities and drive results with limited supervision

Required Education and Training

• Minimum B.S. in Biomedical Engineering, Mechanical Engineering, or similar
• Minimum 8 years of related experience in Clinical Engineering and/or product development within the medical device industry

Preferred Skills and Experience

• 1-3 years of experience managing an engineering team
• Experience developing complex medical robotic platforms
• Experience developing and executing a preclinical strategy to assess solutions
• Experience executing clinical trials including case support

Job Requirements:

• Must be available to work full-time and commute/relocate to Sunnyvale, CA
• Up to 25% travel. Some international travel may be required.
• Primary Location: Sunnyvale, CA

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.