Manager Clinical Development Engineering
Company: Intuitive
Location: Sunnyvale
Posted on: June 16, 2022
Job Description:
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 Clinical Development Engineering team at Intuitive Surgical
holds a unique position within product and procedure development by
identifying clinical value through enabling the safe, effective,
and reliable use of surgical robotic platforms and their
components.
The Clinical Development Engineering Manager will lead a team of
Clinical Development Engineers in the development of digital & data
solutions that effectively augment and support robotic surgery to
ultimately improve clinical outcomes for patients. The Clinical
Development Engineering Manager provides leadership through
thinking broadly, working cross-functionally, supporting
collaboration, and building strong empowering foundations. We are
looking for someone with the ability to keenly observe the surgical
environment and robotic ecosystem, quickly absorb relevant
information, help identify clinical needs and risks, and manage the
execution of assessments and design validations to drive product
development. Additionally, they recruit, develop, inspire, engage,
and retain high performing clinical development engineers.
Primary Function of Position:
The Clinical Development Engineering (CDE) Manager leads a team and
uses their in-depth knowledge of the Da Vinci Surgical Systems and
surgical workflows to work with clinicians and cross-functional
partners to develop safe and highly effective digital & data
products. The CDE Manager is responsible for establishing
data-driven clinical requirements, the validation of new products
to ensure high-quality patient outcomes, and for conveying clinical
value throughout the organization.
Roles and Responsibilities:
Digital & Data Product Development
- Understands the clinical needs of surgeon and OR team and
monitors the progression of state-of-the-art surgical technique and
technologies to help define digital & data products that provide
clinical value for the patient and are technically feasible.
- Works with cross-functional partners, internal SMEs and
surgeons, and external KOLs to identify the clinical value and
potential market opportunity of new Da Vinci surgical digital &
data products
- Collaborates with cross-functional partners, including NPD
Engineering, Marketing, Clinical Affairs, Regulatory Affairs,
Quality, and Project Management to develop and launch new digital &
data products that enhance and support robotic surgery.
- Provides assessment of complex trade-offs, challenges, and
risks with new digital & data products to the product development
team to ensure broad market acceptance of new product designs.
- Contributes to the strategic plan and roadmap for future
digital & data product development, working with internal and
external stakeholders
- Builds strong, trusting relationships with Digital & Data
business unit partners and leaders and promotes CDE opportunities
for collaboration and support
- Manages clinical development engineering activities and
resources related to new product development:
- Developing clinical product requirements and performance
goals
- Assessing and documenting clinical risks and mitigations and
advising engineering regarding risks and mitigations
- Providing clinical guidance to engineering product design
teams
- Performing informal assessments of the clinical performance of
prototype designs
- Creating and executing formal clinical validations of final
product designs
- Supporting first human use and/or launch of new products
- Articulates and promotes process improvements that accelerate
or strengthen product development processes and results.
- Supports strategic planning and creation of regulatory
submissions and first human use of product
- Works with cross-functional user facing teams (HF, IxD,
marketing/sales) to identify and collaborate with key opinion
leaders and together provide a unified "voice of the customer"
- Works with upstream colleagues to identify product enhancements
and influence new ideas by leading data driven clinical evaluations
and research
- Works with downstream colleagues to support clinical trials for
our products and their applications, establish best practices, and
validate marketing claims
- Communicates across all parts of the organization: training,
research, design, manufacturing, quality, marketing, sales, and
regulatory Management
- Organization:
- Keeps the organization's vision, values, strategy, and goals at
the forefront of decision making and action
- Consistently demonstrates culture and values of the
organization internally and externally
- Team:
- Hires, trains, and develops high performing staff, and supports
their long-term professional development. Coaches and provides
feedback on an ongoing basis
- Provides vision for the team ensuring successful development of
new digital and data products and solutions. Fosters an environment
that encourages creativity and crisp execution and recognizes
achievements, contributions, and learning
- Develops methodology and encourages team members to use
accurate data and appropriate judgment to form decisions
- Establishes sub-team objectives and work goals consistent with
overall departmental and project goals. Facilitates alignment of
priorities, reviews metrics and tracks progress
- Assesses employee performance and provides coaching to improve
performance
- Influences and builds bridges across CDE and cross-functional
teams and throughout the Digital & Data business unit to improve
communication and processes; keeps team on target and collaborates
with functional leadership to resolve conflicts quickly
- Seeks, recognizes, and executes creative and simple solutions
to resolve complex situations; routinely steadies the team when
stressed; leads by example Qualifications
Skill/Job Requirements:
- Minimum Bachelor of Science degree required in Engineering or
equivalent
- Minimum 6+ years of experience in medical device product
development (surgical devices preferred)
- A leader who is a consistent high performer, a continual
learner and leads with emotional intelligence
- A team player. Experience in managing direct reports is a
plus
- Self-starter with ability to take leadership in a fast-paced
and dynamic environment
- Experience interacting with surgeons and their teams in an
operating room environment with recognized clinical credibility and
surgical acumen. Fluent in surgical terminology and sound knowledge
of anatomy and surgical technique
- Aptitude to cultivate collaboration with Key Opinion Leaders
and influence cross-functional teams without formal authority to
ensure project success
- Proven success in recognizing critical issues with the ability
to react quickly under pressure and driving issues to closure by
providing coordinated direction. Creative in succeeding
- Strong project management, planning, decision making,
negotiating and change management skills
- Excellent communication skills (verbal, written, presentation)
and experience conveying complex ideas to others
- OR/Scrub experience, cadaveric, and animal surgical experience
a plus
- Ability to travel up to 25%, international and domestic
Additional Information
All your information will be kept confidential according to EEO
guidelines.
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.
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Keywords: Intuitive, Sunnyvale , Manager Clinical Development Engineering, Executive , Sunnyvale, California
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