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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 perform procedures without limitations.
As a leader in robotic-assisted surgery, we are dedicated to cultivating a diverse and inclusive workforce, committed to making a significant impact in the healthcare industry.
For over 25 years, we have collaborated with hospitals and healthcare teams globally to tackle some of the most challenging issues in healthcare and push the boundaries of what is achievable.
Intuitive Surgical thrives on the contributions of talented individuals from various backgrounds. We believe that exceptional ideas can emerge from anywhere, and we are committed to fostering a culture of inclusivity that values diverse perspectives and mutual respect. Our passionate team members are the heartbeat of our culture.
We are dedicated to investing in our employees' long-term development, enabling them to grow and reach their full potential while advancing our mission.
Together, we are committed to making significant strides for healthcare professionals and their patients worldwide.
Position Overview:
The Senior Quality Engineer will play a crucial role in ensuring the reliability, quality, and safety of our products as the da Vinci Surgical System gains traction among hospitals, surgeons, and patients. This role encompasses product performance, manufacturing processes, and design integrity.
We seek a highly skilled technical contributor to assist in product development from conception to market launch, serving as an integral member of the cross-functional product development team.
This individual will provide expertise in Design Controls, Risk Management, Software Development Life Cycle, and Design for Reliability and Manufacturing, ensuring that our products adhere to the highest quality standards and comply with all regulatory requirements.
The ideal candidate will possess extensive experience and technical depth, demonstrating leadership as we establish best practices within our organization.
We value efficiency and innovation, and you will be encouraged to pursue the most effective methods for ensuring product quality. Additionally, you will mentor and guide engineering staff in quality practices, design for quality, manufacturability, and reliability methodologies.
Key Responsibilities:
- Contribute to product development efforts for software and hardware projects, overseeing design controls, process controls, risk management, and SDLC deliverables.
- Review and provide quality and compliance input to project teams for critical 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 contribute to risk analysis through cross-functional collaboration.
- Apply systematic problem-solving methodologies to identify and resolve quality issues effectively.
- Provide quality leadership for new product development and sustaining teams.
- Assist in supplier selection, qualification, and performance improvement initiatives.
- Support Regulatory Affairs with submission preparations and audits.
Qualifications:
Education: A minimum of a Bachelor's degree in electrical, mechanical, or systems engineering, mathematics, or physics.
At least 8 years of experience in Quality Engineering, with a minimum of 4 years in electromechanical systems and software design within the Medical Device sector.
Proficient understanding of design control and risk management throughout the product lifecycle.
Experience with medical standards compliance, including ISO 13485, ISO 14971, ISO 62304, ISO 60601, IEC 62366, and FDA Quality System Regulations.
Demonstrated ability to navigate quality systems independently and make balanced risk decisions to enhance product quality.
Strong communication skills to articulate complex information to diverse teams, including executive management.
Additional Information: Intuitive Surgical is an Equal Employment Opportunity Employer, committed to providing equal opportunities to all qualified applicants and employees, without discrimination based on race, sex, sexual orientation, gender identity, national origin, age, religion, protected veteran or disability status, or any other status protected by law.
