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Lead Quality Assurance Engineer
2 months ago
At Intuitive, we are driven by our mission: we believe that minimally invasive care enhances lives. Through innovation and smart technology, we empower physicians to heal without limitations.
As a trailblazer and leader in robotic-assisted surgery, we are dedicated to cultivating a diverse and inclusive workforce, committed to making a positive impact.
For over 25 years, we have collaborated with healthcare providers globally to tackle some of the toughest challenges in healthcare and expand the boundaries of what is achievable.
Intuitive has been shaped by the contributions of talented individuals from various backgrounds. We believe that great ideas can emerge from anywhere. Our aim is to nurture an inclusive culture centered on diverse perspectives and mutual respect. We prioritize inclusion and empower our team members to perform at their best as their authentic selves.
Our culture is driven by passionate individuals who aspire to make a difference.
Position Overview:
The role of Senior Quality Engineer is essential as Intuitive's da Vinci Surgical System gains traction among a growing number of hospitals, surgeons, and patients. We are assembling a dedicated team to enhance reliability, quality, and safety.
This focus encompasses products in use, in manufacturing, and in design. Your hands-on experience in addressing complex engineering challenges, your enthusiasm for intricate electro-mechanical devices, and your commitment to best practices in product and process design, monitoring, and improvement will be invaluable.
Intuitive seeks a proficient technical contributor to aid in product development from concept to commercialization, serving as a vital member of the cross-functional product development team.
This individual will offer expertise and guidance on Design Controls, Risk Management, Software Development Life Cycle, and Design for Reliability and Manufacturing.
Moreover, this position will play a crucial role in ensuring that developed products adhere to quality standards aligned with Intuitive's quality processes while complying with all external design control and regulatory requirements.
The ideal candidate will possess extensive experience and a high level of technical expertise and leadership as we establish standard practices within our organization.
You will seek efficient methods to integrate product quality without being hindered by bureaucratic processes. Additionally, you will mentor and influence engineering staff in best quality practices, design for quality, manufacturability, and reliability methodologies.
Key Responsibilities:
- Contribute to product development efforts on software and hardware projects, primarily overseeing design controls, process controls, risk management, and SDLC deliverables.
- Possess working knowledge of Design Controls, Risk Management, and Software Development Lifecycle Process; provide quality and compliance input to project teams for project decisions and associated deliverables.
- Support the creation of product design history files and ensure compliance with internal processes and external standards and regulations.
- Collaborate with engineering to define design inputs, outputs, and traceability matrices.
- Develop Risk Management Plans and Reports and assist in the creation and review of risk analyses through cross-functional collaboration.
- Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
- Provide quality leadership for new products and sustaining development teams, ensuring appropriate translation of user needs into design inputs.
- Support the development of product risk management files to assess risks associated with user, design, process, and supplier.
- Ensure designs are reliable and scalable for manufacturing.
- Assist in supplier selection, qualification, certification, and performance enhancement.
- Contribute to new product development Technical Reviews and Design Reviews.
- Support Regulatory Affairs in creating submissions and addressing submission inquiries.
- Assist with internal and external audits, including preparation and direct interaction with auditors.
Qualifications:
- Minimum 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 and development 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.
- Familiarity with medical standards compliance, including ISO 13485, ISO 14971, ISO 62304, ISO 60601, IEC 62366, and FDA Quality System Regulations.
- Able to navigate quality systems with minimal oversight on personal projects.
- Exhibit balanced risk decision-making to enhance product quality and work through technical challenges.
- Ability to articulate complex information to teams, including executive management.
Additional Information:
Due to the nature of our business, Intuitive may require proof of vaccination against certain diseases.
Intuitive is an Equal Employment Opportunity Employer, providing equal opportunities to all qualified applicants and employees, prohibiting discrimination and harassment of any type.
We offer competitive compensation packages, including base pay, incentives, benefits, and equity.
