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Lead Quality Assurance Engineer for Electromechanical Systems
2 months ago
At Intuitive, we are driven by a singular mission: to enhance lives through minimally invasive healthcare solutions. Our innovative spirit and advanced technology empower healthcare professionals to perform their duties without limitations.
As a trailblazer in robotic-assisted surgical systems, we are dedicated to cultivating a diverse and inclusive workforce, united in our goal to make a significant impact in the healthcare sector. For over 25 years, we have collaborated with medical institutions and care teams globally to tackle some of the most pressing challenges in healthcare and redefine what is achievable.
Intuitive thrives on the contributions of individuals from varied backgrounds. We believe that exceptional ideas can emerge from anywhere, and we are committed to nurturing an inclusive environment that values diverse perspectives and mutual respect. Our culture is fueled by passionate individuals who aspire to make a difference. Our team members exemplify integrity, possess a strong desire to learn, and bring a wealth of real-world experiences that inspire innovative thinking. We invest in our team members' growth to help them reach their full potential while advancing our mission.
Join us in our commitment to revolutionizing healthcare for professionals and patients alike. Together, we can elevate the standards of minimally invasive care.
Key Responsibilities:
As a Senior Quality Engineer, you will play a pivotal role in the development of cutting-edge surgical systems, including cameras, instruments, and accessories. Your expertise will be crucial in supporting projects that lead to the creation of next-generation innovative products.
The Senior Quality Engineer will engage in product development from initial concept through to market introduction, serving as an integral member of the cross-functional product development team. You will provide essential guidance on design control, risk management, the Software Development Life Cycle, and principles of Design for Reliability and Manufacturing. Furthermore, you will ensure that all developed products adhere to quality standards in line with Intuitive's quality protocols while complying with external design control and regulatory requirements.
Core Duties:
- Actively contribute to the planning and execution of design controls, risk management, and design verification/validation for new products.
- Assist in the creation of the product design history file, ensuring adherence to internal processes and external regulations.
- Translate user requirements into design specifications while ensuring compliance with usability and human factors standards.
- Collaborate with engineering teams to define design inputs, outputs, and traceability matrices.
- Support the development of risk-based design verification and validation strategies.
- Contribute to the product risk management file, assessing risks associated with user needs, design, processes, and suppliers.
- Ensure designs are reliable and scalable for manufacturing.
- Review design architectures, requirements, and drawings from the early design phase.
- Work closely with manufacturing, purchasing, test engineering, and supplier engineering to facilitate the transition of scalable designs into production.
- Assist in the selection, qualification, certification, and performance enhancement of suppliers.
- Participate in Technical Reviews and Design Reviews for new product development.
- Support Regulatory Affairs by preparing submissions and addressing inquiries related to submissions.
- Assist with internal and external audits, including preparation and direct engagement with auditors.
Required Skills and Experience:
- 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, Systems Engineering, or Design Assurance, with a minimum of 4 years in electromechanical systems and/or software design and development.
- Comprehensive understanding of design control and risk management from initial design through commercialization; demonstrated experience with electromechanical systems from concept to launch is essential.
- Ability to drive design modifications based on risk assessments, testing outcomes, and user requirements.
- Experience in influencing design team processes to enhance design rigor.
- Familiarity with medical standards compliance, including ISO 13485, ISO 14971, and FDA Quality System Regulations, focusing on design controls and optimization.
- Capable of navigating quality systems with minimal oversight on personal projects.
- Balanced decision-making skills to drive product quality, achieve consensus, and resolve technical challenges.
- Proficient in articulating complex information to teams, including executive management.
Due to the nature of our business, it may be necessary for Intuitive and/or its clients to require proof of vaccination against certain diseases, including COVID-19. Specific requirements may vary by role.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, prohibiting discrimination and harassment of any kind, regardless of race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information, or any other status protected under applicable laws.
We will consider qualified applicants with arrest and conviction records in accordance with fair chance laws.
We offer competitive compensation packages, including base pay, incentives, benefits, and equity. Actual pay will be determined based on various factors, including experience, skills, and qualifications.
