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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 sector.
For over 25 years, we have collaborated with healthcare providers globally to tackle some of the most challenging issues in the industry and push the boundaries of what is achievable.
Our organization 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 team is characterized by integrity, a strong willingness to learn, and a passion for excellence.
We invest in our employees' long-term development, enabling them to grow alongside our mission and reach their fullest potential.
Together, we are advancing the future of minimally invasive care.
Position Overview:
The Senior Quality Engineer role is pivotal as we expand the adoption of the da Vinci Surgical System among hospitals, surgeons, and patients. This position is focused on enhancing reliability, quality, and safety across all stages of product development.
We are seeking a highly skilled technical contributor to support product development from initial concept to market launch, serving as a key member of the cross-functional product development team.
This role will involve providing expertise in Design Controls, Risk Management, Software Development Life Cycle, and Design for Reliability and Manufacturing.
Additionally, the Senior Quality Engineer will ensure that our products adhere to quality standards aligned with Intuitive's quality processes while meeting all regulatory requirements.
The ideal candidate will possess extensive experience and technical acumen, contributing to the establishment of standard practices within our organization.
You will actively seek efficient methods to enhance product quality and mentor engineering staff in best practices for quality design, manufacturability, and reliability.
Key Responsibilities:
- Drive product development initiatives for software and hardware projects, overseeing design controls, process controls, risk management, and SDLC deliverables.
- Collaborate with project teams to provide quality and compliance insights for critical project decisions and deliverables.
- Develop and maintain product design history files, ensuring compliance with internal processes and external regulations.
- Partner with engineering teams to define design inputs, outputs, and traceability matrices.
- Create Risk Management Plans and Reports, facilitating top-down and bottom-up risk analysis through cross-functional collaboration.
- Apply systematic problem-solving methodologies to identify, prioritize, and resolve quality issues.
- Provide quality leadership for new product development and sustaining engineering teams.
- Ensure effective translation of user needs into design inputs while adhering to applicable standards and regulations.
- Support the development of product risk management files to assess risks associated with user, design, process, and suppliers.
- Review design architectures and collaborate with manufacturing and engineering teams to ensure scalable designs for production.
- Assist in supplier selection, qualification, and performance improvement initiatives.
- Contribute to technical and design reviews for new product development.
- Support Regulatory Affairs in creating submissions and addressing inquiries.
- Engage in internal and external audits, preparing documentation and interacting with auditors.
Qualifications:
- Bachelor's degree in electrical, mechanical, or systems engineering, mathematics, or physics.
- Minimum of 8 years of experience in Quality Engineering, with at least 4 years in electromechanical systems and software design within the Medical Device sector.
- Strong understanding of design control and risk management processes from design through commercialization.
- Proven experience with electromechanical systems (including software) from concept to launch.
- Familiarity with medical standards compliance, including ISO 13485, ISO 14971, ISO 62304, ISO 60601, IEC 62366, and FDA Quality System Regulations.
- Ability to navigate quality systems with minimal oversight.
- Proficient in risk-based decision-making to enhance product quality and resolve technical challenges.
- Capable of articulating complex information effectively to teams and 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, providing equal opportunities to all qualified applicants and employees.
We offer competitive compensation packages, including base pay, incentives, benefits, and equity.
