Senior Quality Engineer - Forward​/NPD

Position: Senior Quality Engineer - Future Forward / NPD
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:

Intuitive Surgical designs and manufactures highly complex surgical systems including

cameras, instruments, and accessories for use in surgery. We are looking for a strong

quality functional leader to support the projects associated with the development of next

generation products.

The Quality Engineer supports product development from concept through

commercialization and serves as a core team member of the cross-functional product

development team. This role provides expertise and guidance on design controls, risk

management, process validation, and design for reliability and manufacturing.

Additionally, the position ensures that developed products meet quality standards

consistent with Intuitive' s quality processes and all external design control and regulatory

requirements.

Roles & Responsibilities :

Design Controls and

Risk Management:

o Contribute to the planning and execution of design controls, risk management,

and design verification/validation for new products.

o Participate in and support the development of the product design history file,

ensuring compliance with internal processes and external standards and

regulations.

o Understand user needs and ensure they are translated into the design, while

complying with 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 in and support the development of the product risk management file,

analyzing and assessing product risks associated with user, design, process, and

supplier.

Design Transfer:

o Ensure reliable and scalable designs are transferred to manufacturing.

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

design stages.

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

engineering to facilitate the 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.

Regulatory Support:

o Support Regulatory Affairs with creating submissions and responding to

submission questions.

o Support internal and external audits, including preparation and direct interaction

with auditors.

Process Improvement & Cross-Functional Collaboration

o Support continuous improvement in design control & risk management quality

processes and methodologies.

Qualifications

Qualifications

Skills, Experience, Education, & Training:

Requires a minimum of 8 years of related experience with a University Degree (in

Electrical Engineering, Mechanical Engineering, Computer Science, software engineering,

biomedical engineering), or 6 years of relevant experience and an Advanced Degree.

Strong proficiency in FDA Design Controls and international standards, including ISO

13485, ISO 14971, and IEC 60601/62304. Previous experience with risk-based V&V,

process validation, and limit/challenge testing are required.

Experience working with robotic or complex electromechanical devices is preferred.

Previous experience with…