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Lead Quality Assurance Engineer
2 months ago
At Intuitive Surgical, we are driven by a singular mission: to enhance lives through minimally invasive care. Our innovative technology empowers healthcare professionals to provide exceptional care without limitations.
As a leader in robotic-assisted surgery, we are dedicated to cultivating a diverse and inclusive workforce, united in our commitment to effecting positive change in healthcare.
For over 25 years, we have collaborated with healthcare providers globally to tackle some of the most challenging issues in the industry and to push the boundaries of what is achievable.
Our organization thrives on the contributions of talented individuals from various backgrounds. We believe that the best ideas can emerge from anywhere and strive to create an inclusive environment that values diverse perspectives and mutual respect. Our culture is fueled by passionate individuals who are eager to make a meaningful impact.
We invest in our employees' long-term development, enabling them to grow and reach their fullest potential while advancing our mission.
Together, we are committed to making significant advancements for healthcare professionals and their patients around the world.
Position Overview:
The Senior Quality Engineer role focuses on enhancing the reliability, quality, and safety of our da Vinci Surgical System as it gains traction among hospitals, surgeons, and patients. This position encompasses product usage, manufacturing, and design.
We seek a dedicated technical expert to support product development from initial concept to market launch, serving as a vital member of the cross-functional product development team.
This individual will offer expertise in Design Controls, Risk Management, Software Development Life Cycle, and Design for Reliability and Manufacturing.
Moreover, this role is crucial in ensuring that our products adhere to quality standards aligned with Intuitive's quality processes and comply with all external design control and regulatory requirements.
The ideal candidate will possess extensive experience and a high level of technical acumen, providing leadership as we establish best practices within our organization.
You will prioritize efficiency over bureaucratic processes, striving to integrate quality into our products seamlessly. Additionally, you will mentor and guide engineering staff in best practices for quality, design, manufacturability, and reliability.
Key Responsibilities:
- Contribute to product development efforts for software and hardware projects, primarily overseeing design controls, process controls, risk management, and SDLC deliverables.
- Possess a solid understanding of Design Controls, Risk Management, and Software Development Lifecycle Process; provide quality and compliance input to project teams for project decisions and deliverables.
- Support the creation of product design history files and ensure adherence to internal processes and external standards.
- Collaborate with engineering teams to define design inputs, outputs, and traceability matrices.
- Develop Risk Management Plans and Reports and contribute to risk analysis through cross-functional collaboration.
- Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
- Provide quality leadership for new product development and sustaining teams.
- Ensure user needs are accurately translated into design inputs while maintaining compliance with applicable standards.
- Participate in the development of product risk management files to assess risks associated with user, design, process, and supplier.
- Review design architectures and collaborate with manufacturing and supplier engineering to facilitate the transition of designs into production.
- Assist in supplier selection, qualification, and performance improvement.
- Support Regulatory Affairs with submissions and audits.
Qualifications:
Education:
A minimum of a Bachelor's degree in electrical, mechanical, or systems engineering, mathematics, or physics.
A minimum of 8 years of experience in Quality Engineering, with at least 4 years in electromechanical systems and software design within the Medical Device Industry.
Strong understanding of design control and risk management from early design through commercialization.
Demonstrated experience with electromechanical systems (including software) from concept to launch is essential.
Familiarity with medical standards compliance, including ISO 13485, ISO 14971, ISO 62304, ISO 60601, IEC 62366, and FDA Quality System Regulations, focusing on design controls and optimization.
Ability to navigate quality systems with minimal oversight and make balanced risk decisions to enhance product quality.
Proficient in articulating complex information to teams, including executive management.
Additional Information:
Due to the nature of our business, proof of vaccination against certain diseases may be required.
Intuitive Surgical is an Equal Employment Opportunity Employer, committed to providing equal opportunities to all qualified applicants and employees.
We offer competitive compensation packages, including base pay, incentives, benefits, and equity.
