Senior Quality Engineer - Multiport Da Vinci

Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do  a global leader in robotic-assisted surgery and minimally invasive care, our technologies-like the da Vinci surgical system and Ion-have transformed how care is delivered for millions of patients worldwide.

We're a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful-because every improvement we make has the potential to change a life.

If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.

Job Description

Primary Function of Position:

Senior Quality Engineer supports product development from concept through commercialization

and will serve as the core team member for the cross-functional product development

team. Senior Quality Engineer will provide expertise and guidance to the team on design control

and risk management, Software Development Life Cycle, and Design for Reliability and

Manufacturing. In addition, this position will play an effective role to ensure that the developed

products meet quality standards consistent with Intuitive' s quality processes, while meeting all

external design control and regulatory requirements.

Essential

Job Duties (Specific responsibilities and tasks an individual would be expected to

perform in the role. Additional job duties may be determined by functional managers.

Proven contributor to the planning and execution of design

controls, risk management, and design

verification/validation for new products

o Participate and support the development of product

design history file and ensure compliance to internal

processes and external standards and regulations.

o Understand user needs and assure they are translated to the design, while

ensuring compliance to usability and human factors standards and regulations.

o Partner with engineering to define design inputs, design outputs, and traceability

matrices.

o Contribute to the strategy and execution of risk-based design verification and

validation.

o Participate and support the development of product risk management file, to

analyze and assess the product risks associated with user, design, process and

supplier.

* Ensure reliable and scalable designs to transferred to manufacturing

o Review design architectures, selections, requirements, and drawings from early

design

o Collaborate with manufacturing, purchasing, test engineering, and supplier

engineering to facilitate transfer of scalable designs into production.

o Assist in supplier selection, qualification, certification, and performance

improvement.

o Contribute to new product development Technical Reviews and Design Reviews.

* Support Regulatory Affairs with creating submissions and responding to submission

questions.

* Support internal and external audits, including preparation and direct interaction with

auditors.

Qualifications

Required Skills and Experience

* Minimum 8+ years of working experience in Quality Engineering, minimum 4 years in

electromechanical systems and/or software design and development

Solid understanding of design control and risk management

from early design and development through

commercialization;
Demonstrated experience with

electromechanical system from concept through launch is

required.

* Experience with medical standards compliance, including ISO 13485, ISO 14971 and

FDA Quality System Regulations with a focus on design controls and design optimization.

* Able to navigate quality system with minimal oversight on personal projects.

* Balanced risk decision making to drive product quality, gain consensus, and work through

technical challenges.

* Solves complex problem with minimal oversight.

* Able to articulate complex information to teams, including executive management.

Required Education and Training

* Educat…